Adjuvanted Seasonal Recombinant Quadrivalent Virus-Like Particles (QVLP) Influenza Vaccine in Adults 65 Years of Age and Older
Official Title
A Randomized, Partially-Blinded, Active Comparator-Controlled, Dose-Ranging, Safety, Tolerability, and Immunogenicity Phase 1/2 Study of an Adjuvanted Seasonal Recombinant Quadrivalent VLP Influenza Vaccine in Adults 65 Years of Age and Older
Acronym
Not provided
Organization
MedicagoINDUSTRY
Status Module
Record Verification Date
Jul 2023
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 2, 2020Actual
Primary Completion Date
Apr 26, 2022Actual
Completion Date
Apr 26, 2022Actual
First Submitted Date
Oct 16, 2020
First Submission Date that Met QC Criteria
Nov 3, 2020
First Posted Date
Nov 10, 2020Actual
Results Waived
Not provided
Results First Submitted Date
May 29, 2023
Results First Submitted that Met QC Criteria
Jul 13, 2023
Results First Posted Date
Jul 21, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jul 13, 2023
Last Update Posted Date
Jul 21, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
MedicagoINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This randomized, partially-blinded, active comparator-controlled was conducted at multiple sites globally. The composition of QVLP used in this study includes a mix of recombinant H1, H3, and two B hemagglutinin proteins expressed as VLPs and is based on the 2020-2021 influenza virus strains.
In this study, 3 dose levels (15 μg/strain, 30 μg/strain, and 45 μg/strain) of QVLP were planned to be tested in combination with 2 dose levels of AS03 adjuvant (full and half dose) in a single-dose regimen to select a dose level of QVLP and adjuvant dose level-combination that is safe and effective for further development.
Participants participated in this study for up to approximately 13 months, during which the first visit was scheduled for screening (up to 7 days in advance of vaccine administration) and the second visit on Day 0 was scheduled for vaccine administration. Telephone contacts were made on Day 1, Day 8, and monthly (starting after Day 28) until the end of the study for safety assessments, including concomitant medication use review. Blood draws at the clinic site for key safety assessments were made on Day 3, and Day 28 and for key immunogenicity assessments on Day 0, Day 28, Day 182 (6-month follow-up), and Day 365 (12-month follow-up).
Detailed Description
In this study, a partially-blinded design was applied whereby the following individuals did not have access to treatment allocation (i.e. remained "blind") throughout the entire study duration: the participants, the Investigators and all personnel involved in the clinical conduct of the study (except the staff involved in the preparation and administration of the study vaccine, the quality assurance auditor, and quality control reviewers), Medicago clinical staff and medical staff involved in safety evaluations (e.g. causality assessments), and all personnel involved in sample analysis at the central and testing laboratories.
A total of 209 participants were randomized to the study, divided into 8 groups receiving different adjuvant dose level-combinations of QVLP or Fluzone HD Quad (60 µg/strain). The majority of participants (126 participants) received QVLP 30 μg/strain with full dose AS03 (42 participants), QVLP 30 μg/strain unadjuvanted (41 participants) or Fluzone HD Quad (43 participants), while in 5 other groups with 83 participants enrolled in total the enrollment was discontinued prematurely due to recruitment challenges caused by COVID-19 pandemic.
Conditions Module
Conditions
Influenza
Keywords
vaccine
safety
immunogenicity
plant-made
virus-like particle
hemagglutinin
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
209Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
QVLP15+Full AS03
Experimental
Participants received one intramuscular (IM) injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent virus-like particle (VLP) Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
Biological: Instramuscular vaccine
QVLP15+Half AS03
Experimental
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
Biological: Instramuscular vaccine
QVLP30+Full AS03
Experimental
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
Biological: Instramuscular vaccine
QVLP30+Half AS03
Experimental
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
Biological: Instramuscular vaccine
QVLP45+Full AS03
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Instramuscular vaccine
Biological
On Day 0, a single injection of the assigned dose of the vaccine into the deltoid region of the arm
Fluzone HD Quad
QVLP15+Full AS03
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous Influenza Strain on Day 0
The GMTs in each treatment group were measured using an HI assay for the homologous influenza strains: A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage).
Day 0 (pre-vaccination)
GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 28
The GMTs in each treatment group were measured using an HI assay for the homologous influenza strains: A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage).
Day 28
Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28
Seroconversion rate: the percentage of participants in a given treatment group with either a ≥4-fold increase in reciprocal HI titers between Day 0 and Day 28 or a rise of undetectable HI titer (i.e. < 10) pre-vaccination (Day 0) to an HI titer of ≥ 40 on Day 28 was measured using an HI assay for the homologous influenza strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage).
Day 0 (pre-vaccination) up to Day 28
Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28
Seroprotection rate: the percentage of participants in a given treatment group attaining a reciprocal HI titer of ≥40 on Day 28 (the percentage of vaccine recipients with a serum HI titer of at least 1:40 following vaccination) for the homologous influenza strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage).
Secondary Outcomes
Measure
Description
Time Frame
GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365
The GMTs in each treatment group were measured using an HI assay for the homologous influenza strains: A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage).
Day 182, Day 365
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participants read, understood, and signed the informed consent form prior to participating in the study; participants also completed study-related procedures and communicated with the study staff at visits and by phone during the study;
Male and female participants 65 years of age and older at the Vaccination visit (Visit 2);
Participants had a body mass index (BMI) < 30 kg/m2 at the Vaccination visit (Visit 2);
Participants were considered by the Investigator to be reliable and likely to cooperate with the assessment procedures and be available for the duration of the study;
Participants were non-institutionalized (e.g. not living in rehabilitation centers or old-age homes; living in an elderly community was acceptable) and had no acute or evolving medical problems prior to study participation and no clinically relevant abnormalities that could jeopardize participant safety or interfere with study assessments, as assessed by the Investigator and determined by medical history, physical examination, serology, clinical chemistry and hematology tests, urinalysis, and vital signs. Investigator discretion was permitted with this inclusion criterion;
Note: Participants with a pre-existing chronic disease were allowed to participate if the disease was stable and, according to the Investigator's judgment, the condition was unlikely to confound the results of the study or pose additional risk to the participant by participating in the study. Stable disease was generally defined as no new onset or exacerbation of pre-existing chronic disease 3 months prior to vaccination. Based on the Investigator's judgment, participants with more recent stabilization of a disease were also eligible.
Exclusion Criteria:
According to the Investigator's opinion, significant acute or chronic, uncontrolled medical or neuropsychiatric illness. Acute disease was defined as presence of any moderate or severe acute illness with or without a fever within 48 hours prior to the Vaccination visit (Visit 2). "Uncontrolled" was defined as:
Requiring a new medical or surgical treatment during the 3 months prior to study vaccine administration;
Required any significant change in a chronic medication (i.e. drug, dose, frequency) during the 3 months prior to study vaccine administration due to uncontrolled symptoms or drug toxicity unless the innocuous nature of the medication change met the criteria outlined in inclusion criterion #5 and was appropriately justified and documented by the Investigator. Note: Investigator discretion was permitted with this exclusion criterion.
Any confirmed or suspected current immunosuppressive condition or immunodeficiency, including cancer, human immunodeficiency virus, hepatitis B or C infection (participants with a history of cured hepatitis B or C infection without any signs of immunodeficiency at present time were allowed). Investigator discretion was permitted with this exclusion criterion;
Current autoimmune disease requiring systemic treatment (such as rheumatoid arthritis, systemic lupus erythematosus, or multiple sclerosis). Investigator discretion was permitted with this exclusion criterion, and participants were eligible to participate with appropriate written justification in the source document (i.e. participants with a history of autoimmune disease who were disease-free without treatment for 3 years or more, or on stable thyroid replacement therapy, mild psoriasis [i.e. a small number of minor plaques requiring no systemic treatment], etc.);
Administration of any non-influenza vaccine within 30 days prior to the Vaccination visit (Visit 2); planned administration of any vaccine up to Day 28 of the study. Immunization on an emergency basis during the study was evaluated on case-by-case basis by the Investigator.
Note: Administration of an authorized COVID-19 vaccine prior to or during the study was acceptable;
Administration of influenza vaccine within 6 months prior to the Vaccination visit (Visit 2) or planned administration of influenza vaccine (other than the study vaccine) up to completion of the study;
Administration of any adjuvanted or investigational influenza vaccine within 1 year prior to randomization or planned administration prior to the completion of the study;
Use of any investigational or non-registered product within 30 days or five half-lives, whichever is longer, prior to the Vaccination visit (Visit 2) or planned use during the study period. Participants who were in a prolonged post-administration observation period of another investigational or marketed drug clinical study, for which there was no ongoing exposure to the investigational or marketed product and all scheduled on-site visits were completed, were allowed to take part in this study, if all other eligibility criteria were met;
Administration of any medication or treatment that may alter the vaccine immune responses, such as:
Systemic glucocorticoids at a dose exceeding 10 mg of prednisone (or equivalent) per day for more than 7 consecutive days or for 10 or more days in total, within 1 month prior to the Vaccination visit (Visit 2). Inhaled, nasal, intraarticular, ophthalmic, dermatological, and other topical glucocorticoids were permitted;
Cytotoxic, antineoplastic or immunosuppressant drugs - within 36 months prior to the Vaccination visit (Visit 2);
Any immunoglobulin preparations or blood products, blood transfusion - within 6 months prior to the Vaccination visit (Visit 2);
Use of any prescription antiviral drugs with the intention of COVID-19 prophylaxis, including those that were thought to be effective for prevention of COVID-19 but had not been licensed for this indication, within 1 month prior to the Vaccination visit (Visit 2);
Participants at high risk of contracting SARS-CoV-2/COVID-19 infection, including, but not limited to, individuals with known close contact with:
anyone residing in, visiting, or working at a health care or long-term care institution (i.e. long-term care facilities, acute care hospitals, rehabilitation hospitals, mental health hospitals, emergency departments);
anyone with laboratory-confirmed SARS-CoV-2/COVID-19 infection within 2 weeks prior to vaccine administration;
anyone who traveled outside the country for any duration within 30 days before the study vaccination;
History of allergy to any of the constituents of QVLP, any components of Fluzone HD Quad, the adjuvant AS03, egg, or tobacco;
History of anaphylactic allergic reactions to plants or plants components (including fruits and nuts);
Personal or family (first-degree relatives) history of narcolepsy;
Use of prophylactic medications (e.g. antihistamines [H1 receptor antagonists], nonsteroidal anti-inflammatory drugs [NSAIDs], systemic and topical glucocorticoids, non-opioid and opioid analgesics) within 24 hours prior to the Vaccination visit (Visit 2) to prevent or pre-empt symptoms due to vaccination;
Had a rash, dermatological condition, tattoos, muscle mass, or any other abnormalities at the injection site that could interfere with injection site reaction rating. Investigator discretion was permitted with this exclusion criterion;
Participants identified as an Investigator or employee of the Investigator or clinical site with direct involvement in this study, or identified as an immediate family member (i.e. parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in this study, or any employees of Medicago.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
65 Years
Maximum Age
Not provided
Standard Ages
Older Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Medical Director
Medicago
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Optimal Sites
Huntsville
Alabama
35802-2569
United States
Synexus
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Participants were healthy adult males and females 65 years of age and older.
Recruitment Details
Participants were randomized at an equal ratio into 8 treatment groups to receive Quadrivalent Virus-Like Particles (QVLP) vaccine adjuvanted with AS03 (full and half dose), QVLP vaccine unadjuvanted or Fluzone HD Quad vaccine.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
QVLP15+Full AS03
Participants received one intramuscular (IM) injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent virus-like particle (VLP) Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
Biological: Instramuscular vaccine
QVLP45+Half AS03
Experimental
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
Biological: Instramuscular vaccine
QVLP30 unadjuvanted
Active Comparator
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
Biological: Instramuscular vaccine
Fluzone HD Quad
Active Comparator
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone high dose (HD) Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Biological: Instramuscular vaccine
QVLP15+Half AS03
QVLP30 unadjuvanted
QVLP30+Full AS03
QVLP30+Half AS03
QVLP45+Full AS03
QVLP45+Half AS03
Day 0 (pre-vaccination) up to Day 28
Geometric Mean Fold Rise (GMFR) Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 28/Day 0)
GMFR, the geometric mean of the ratio of GMTs (Day 28/Day 0) in each treatment group was measured using an HI assay for the homologous strains: A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage).
Day 0 (pre-vaccination), Day 28
Number of Participants With at Least One Immediate Adverse Event (AE)
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. Immediate AEs were defined as any solicited (local and systemic) and unsolicited AEs that started up to 30 minutes after vaccination. Solicited local AEs included erythema, swelling, and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck.
Up to 30 minutes post-vaccination
Number of Participants With at Least One Immediate AE of Grade 1, 2, 3, or 4
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. Immediate AEs were defined as any solicited (local and systemic) and unsolicited AEs that started up to 30 minutes after vaccination. Solicited local AEs included erythema, swelling, and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck. The intensity of the AEs was graded according to the United States Food and Drug Administration Toxicity Grading Scale: mild (Grade 1), moderate (Grade 2), severe (Grade 3), or potentially life threatening (Grade 4).
Up to 30 minutes post-vaccination
Number of Participants With at Least One Immediate AE Related to Vaccination
An AE is defined in OM #6. Immediate AEs were defined as any solicited (local and systemic) and unsolicited AEs that started up to 30 minutes after vaccination. Solicited local AEs included erythema, swelling and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck. A related AE is an event where the investigator determined that the relationship to study vaccine was "Possibly Related", "Probably Related" or "Definitely Related". If a participant reported multiple occurrences of the same AE, only the most closely related occurrence was presented. The causal relationship of all solicited local and systemic AEs was considered related to vaccination. Participants with any related AE was reported.
30 minutes post-vaccination
Number of Participants With at Least One Solicited Local or Systemic AE From Day 0 up to Day 7
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. Solicited local AEs included erythema, swelling, and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck.
Day 0 (pre-vaccination) up to Day 7
Number of Participants With at Least One Solicited Local or Systemic AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 7
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. Solicited local AEs included erythema, swelling and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck. The intensity of the AEs was graded according to the FDA Toxicity Grading Scale: mild (Grade 1), moderate (Grade 2), severe (Grade 3), or potentially life threatening (Grade 4).
Day 0 (pre-vaccination) up to Day 7
Number of Participants With at Least One Unsolicited AE From Day 0 up to Day 28
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product.
Day 0 (pre-vaccination) up to Day 28
Number of Participants With at Least One Unsolicited AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 28
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. The intensity of the AEs was graded according to the FDA Toxicity Grading Scale: mild (Grade 1), moderate (Grade 2), severe (Grade 3), or potentially life threatening (Grade 4).
Day 0 (pre-vaccination) up to Day 28
Number of Participants With at Least One Unsolicited AE Related to Vaccination From Day 0 up to Day 28
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. A related AE was an event where the Investigator determined that the relationship to study vaccine was "Possibly Related", "Probably Related" or "Definitely Related". If a participant reported multiple occurrences of the same AE, only the most closely related occurrence was presented. Participants with any related AE were reported.
Day 0 (pre-vaccination) up to Day 28
Number of Participants With at Least One Serious Adverse Events (SAE) From Day 1 up to Day 28
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. An SAE is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event.
Day 1 up to Day 28
Number of Participants With at Least One AE Leading to Withdrawal From the Study From Day 1 up to Day 28
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product.
Day 1 up to Day 28
Number of Participants With at Least One Adverse Event of Special Interest (AESI) From Day 1 up to Day 28
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. AESIs included hypersensitivity reactions, narcolepsy, Potential Immune-Mediated Diseases (pIMDs), and other AESIs. Participants with any AESI were reported.
Day 1 up to Day 28
Number of Participants With at Least One Medically Attended AE (MAAE) From Day 1 up to Day 28
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. MAAEs are defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a healthcare provider.
Day 1 up to Day 28
Number of Participants With at Least One New Onset Clinical Disease (NOCD) From Day 1 up to Day 28
All NOCDs that may plausibly have an allergic, autoimmune or inflammatory component were assessed and reported. Plausibility was interpreted broadly; the only clear exceptions were degenerative conditions such as osteoarthritis, age-related physiologic changes and life-style diseases. In this context, most cancers, cardiac conditions, and kidney diseases had to be reported.
Day 1 up to Day 28
Number of Participants With the Occurrence of Death From Day 1 up to Day 28
The number of participants in each treatment group with an occurrence of death was assessed.
Day 1 up to Day 28
Number of Participants With at Least One SAE From Day 29 up to Day 182
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. An SAE is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event.
Day 29 up to Day 182
Number of Participants With at Least One AE Leading to Withdrawal From the Study From Day 29 up to Day 182
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. The number of participants with at least one AE leading to withdrawal was assessed.
Day 29 up to Day 182
Number of Participants With at Least One AESI From Day 29 up to Day 182
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. AESIs included hypersensitivity reactions, narcolepsy, pIMDs, and other AESIs. Participants with any AESI were reported.
Day 29 up to Day 182
Number of Participants With at Least One MAAE From Day 29 up to Day 182
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. MAAEs are defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider.
Day 29 up to Day 182
Number of Participants With at Least One New NOCD From Day 29 up to Day 182
All NOCDs that may plausibly have an allergic, autoimmune or inflammatory component were assessed and reported. Plausibility was interpreted broadly; the only clear exceptions were degenerative conditions such as osteoarthritis, age-related physiologic changes and life-style diseases. In this context, most cancers, cardiac conditions, and kidney diseases were reported.
Day 29 up to Day 182
Number of Participants With an Occurrence of Death From Day 29 up to Day 182
The number of participants in each treatment group with an occurrence of death was assessed.
Day 29 up to Day 182
Number of Participants With at Least One SAE From Day 183 up to Day 365
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. An SAE is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event.
Day 183 up to the end of study (Day 365)
Number of Participants With at Least One AE Leading to Withdrawal From the Study From Day 183 up to Day 365
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. The number of participants with at least one AE leading to withdrawal was assessed.
Day 183 up to the end of study (Day 365)
Number of Participants With at Least One AESI From Day 183 up to Day 365
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. AESIs included hypersensitivity reactions, narcolepsy, pIMDs, and other AESIs. Participants with any AESI were reported.
Day 183 up to the end of study (Day 365)
Number of Participants With at Least One MAAE From Day 183 up to Day 365
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. MAAEs were defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider.
Day 183 up to the end of study (Day 365)
Number of Participants With at Least One NOCD From Day 183 up to Day 365
All NOCDs that may plausibly have an allergic, autoimmune or inflammatory component were assessed and reported. Plausibility should be interpreted broadly; the only clear exceptions are degenerative conditions such as osteoarthritis, age-related physiologic changes and life-style diseases. In this context, most cancers, cardiac conditions, and kidney diseases should be reported.
Day 183 up to the end of study (Day 365)
Number of Participants With an Occurrence of Death From Day 183 up to Day 365
The number of participants in each treatment group with an occurrence of death was assessed.
Day 183 up to the end of study (Day 365)
Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 0
Participants were monitored for any abnormal findings in urine parameters (urine color, glucose, occult blood, protein, specific gravity, specimen appearance, pH), hematological parameters (basophils, leukocytes, eosinophils, erythrocytes mean corpuscular hemoglobin, erythrocytes, hematocrit, hemoglobin, lymphocytes, mean platelet volume, monocytes, neutrophils, platelets), and blood chemistry parameters (alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, calcium, chloride, cholesterol, creatinine, gamma glutamyl transferase, glucose, HDL and LDL cholesterol, phosphate, potassium, protein, sodium, triglycerides, urea nitrogen). Any laboratory result outside of the testing laboratory's normal range was classified as "clinically significant" or "not clinically significant" by the site investigator, with appropriate documentation.
Day 0 (pre-vaccination)
Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 3
Participants were monitored for any abnormal findings in urine parameters (urine color, glucose, occult blood, protein, specific gravity, specimen appearance, pH), hematological parameters (basophils, leukocytes, eosinophils, erythrocytes mean corpuscular hemoglobin, erythrocytes, hematocrit, hemoglobin, lymphocytes, mean platelet volume, monocytes, neutrophils, platelets), and blood chemistry parameters (alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, calcium, chloride, cholesterol, creatinine, gamma glutamyl transferase, glucose, HDL and LDL cholesterol, phosphate, potassium, protein, sodium, triglycerides, urea nitrogen). Any laboratory result outside of the testing laboratory's normal range was classified as "clinically significant" or "not clinically significant" by the site investigator, with appropriate documentation.
Day 3
Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 28
Participants were monitored for any abnormal findings in urine parameters (urine color, glucose, occult blood, protein, specific gravity, specimen appearance, and pH), hematological parameters (basophils, leukocytes, eosinophils, erythrocytes mean corpuscular hemoglobin, erythrocytes, hematocrit, hemoglobin, lymphocytes, mean platelet volume, monocytes, neutrophils, and platelets), and blood chemistry parameters (alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, calcium, chloride, cholesterol, creatinine, gamma glutamyl transferase, glucose, cholesterol, phosphate, potassium, protein, sodium, triglycerides, and urea nitrogen). Any laboratory result outside of the testing laboratory's normal range was classified as "clinically significant" or "not clinically significant" by the site investigator, with appropriate documentation.
Day 28
Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365
Seroconversion rate: the percentage of participants in a given treatment group with either a ≥4-fold increase in reciprocal HI titers between Day 0 and Day 182 and Day 0 and Day 365 or a rise of undetectable HI titer (i.e. <10) pre-vaccination (Day 0) to an HI titer of ≥40 on Day 182 and Day 365 was measured using an HI assay for the following homologous influenza strains: A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage).
Day 0 (pre-vaccination) up to Day 182 and up to Day 365
Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365
Seroprotection rate: the percentage of participants in a given treatment group attaining a reciprocal HI titer of ≥40 on Day 182 and on Day 365 (the percentage of vaccine recipients with a serum HI titer of at least 1:40 following vaccination) for the homologous influenza strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage)
Day 0 (pre-vaccination) up to Day 182 and up to Day 365
GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0)
GMFR: the geometric mean of the ratio of GMTs (Day 182/Day 0 and Day 365/Day 0) measured using an HI assay for the homologous strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage).
Day 0 (pre-vaccination), Day 182, Day 365
GMTs of HI Antibody Response for Each Heterologous Influenza Strain
The GMTs in each treatment group were measured using an HI assay for the heterologous influenza strains: A/Brisbane/02/2018 (H1N1), A/Kansas/14/2017 (H3N2), and B/Maryland/15/2016 (B/Victoria lineage).
Day 0 (pre-vaccination), Day 28
Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Heterologous Influenza Strain
Seroconversion rate: the percentage of participants in a given treatment group with either a ≥4-fold increase in reciprocal HI titers between Day 0 and Day 28 or a rise of undetectable HI titer (i.e. <10) pre-vaccination (Day 0) to an HI titer of ≥40 on Day 28 was measured using an HI assay for the heterologous influenza strains A/Brisbane/02/2018 (H1N1), A/Kansas/14/2017 (H3N2), and B/Maryland/15/2016 (B/Victoria lineage).
Day 0 (pre-vaccination) up to Day 28
Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Heterologous Influenza Strain
Seroprotection rate: the percentage of participants in a given treatment group attaining a reciprocal HI titer of ≥40 on Day 28 (the percentage of vaccine recipients with a serum HI titer of at least 1:40 following vaccination) for the heterologous influenza strains A/Brisbane/02/2018 (H1N1), A/Kansas/14/2017 (H3N2), and B/Maryland/15/2016 (B/Victoria lineage)
Day 0 (pre-vaccination) up to Day 28
GMFR Measured by HI Antibody Response for Each Heterologous Influenza Strain
GMFR: the geometric mean of the ratio of GMTs (Day 28/Day 0) measured using an HI assay for the heterologous strains A/Brisbane/02/2018 (H1N1), A/Kansas/14/2017 (H3N2), and B/Maryland/15/2016 (B/Victoria lineage).
Day 0 (pre-vaccination), Day 28
GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain
The GMTs in each treatment group were measured using an MN assay for the homologous influenza strains: A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage).
Day 0 (pre-vaccination), Day 28
Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Influenza Strain
Seroconversion rate: the percentage of participants in a given treatment group with either a ≥4-fold increase in reciprocal HI titers between Day 0 and Day 28 or a rise of undetectable MN titer (i.e. <10) pre-vaccination (Day 0) to an MN titer of ≥40 on Day 28 was measured using an MN assay for the homologous influenza strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage).
Day 0 (pre-vaccination) up to Day 28
GMFR Measured by MN Antibody Response for Each Homologous Influenza Strain
GMFR: the geometric mean of the ratio of GMTs (Day 28/Day 0) measured using an MN assay for the homologous strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage).
Day 0 (pre-vaccination), Day 28
GMTs of HI Antibody Response for Each Homologous Influenza Strain, Stratified by Prior Influenza Vaccination Status
The GMTs in each treatment group were measured using an HI assay for the homologous influenza strains: A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Day 0 (pre-vaccination), Day 28
Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain, Stratified by Prior Influenza Vaccination Status
Seroconversion rate: the percentage of participants in a given treatment group with either a ≥4-fold increase in reciprocal HI titers between Day 0 and Day 28 or a rise of undetectable HI titer (i.e. <10) pre-vaccination (Day 0) to an HI titer of ≥40 on Day 28 was measured using an HI assay for the homologous influenza strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Day 0 (pre-vaccination) up to Day 28
Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain, Stratified by Prior Influenza Vaccination Status
Seroprotection rate: the percentage of participants in a given treatment group attaining a reciprocal HI titer of ≥40 on Day 28 (the percentage of vaccine recipients with a serum HI titer of at least 1:40 following vaccination) for the homologous influenza strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Day 0 (pre-vaccination) up to Day 28
GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain, Stratified by Prior Influenza Vaccination Status
GMFR: the geometric mean of the ratio of GMTs (Day 28/Day 0) measured using an HI assay for the homologous strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Day 0 (pre-vaccination), Day 28
GMTs of HI Antibody Response for Each Heterologous Influenza Strain, Stratified by Prior Influenza Vaccination Status
The GMTs in each treatment group were measured using an HI assay for the heterologous influenza strains: A/Brisbane/02/2018 (H1N1), A/Kansas/14/2017 (H3N2), and B/Maryland/15/2016 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination. It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Day 0 (pre-vaccination), Day 28
Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Heterologous Influenza Strain, Stratified by Prior Influenza Vaccination Status
Seroconversion rate: the percentage of participants in a given treatment group with either a ≥4-fold increase in reciprocal HI titers between Day 0 and Day 28 or a rise of undetectable HI titer (i.e. <10) pre-vaccination (Day 0) to an HI titer of ≥40 on Day 28 was measured using an HI assay for the following heterologous influenza strains: A/Brisbane/02/2018 (H1N1), A/Kansas/14/2017 (H3N2), and B/Maryland/15/2016 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Day 0 (pre-vaccination) up to Day 28
Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Heterologous Influenza Strain, Stratified by Prior Influenza Vaccination Status
Seroprotection rate: the percentage of participants in a given treatment group attaining a reciprocal HI titer of ≥40 on Day 28 (the percentage of vaccine recipients with a serum HI titer of at least 1:40 following vaccination) for the following heterologous influenza strains: A/Brisbane/02/2018 (H1N1), A/Kansas/14/2017 (H3N2), and B/Maryland/15/2016 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Day 0 (pre-vaccination) up to Day 28
GMFR Measured by HI Antibody Response for Each Heterologous Influenza Strain, Stratified by Prior Influenza Vaccination Status
GMFR: the geometric mean of the ratio of GMTs (Day 28/Day 0) measured using an HI assay for the heterologous strains A/Brisbane/02/2018 (H1N1), A/Kansas/14/2017 (H3N2), and B/Maryland/15/2016 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Day 0 (pre-vaccination), Day 28
GMTs of MN Antibody Response for Each Homologous Influenza Strain, Stratified by Prior Influenza Vaccination Status
The GMTs in each treatment group were measured using an MN assay for the following homologous influenza strains: A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Day 0 (pre-vaccination), Day 28
Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Influenza Strain, Stratified by Prior Influenza Vaccination Status
Seroconversion rate: the percentage of participants in a given treatment group with either a ≥4-fold increase in reciprocal HI titers between Day 0 and Day 28 or a rise of undetectable MN titer (i.e. <10) pre-vaccination (Day 0) to an MN titer of ≥40 on Day 28 was measured using an MN assay for the homologous influenza strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Day 0 (pre-vaccination) up to Day 28
GMFR Measured by MN Antibody Response for Each Homologous Influenza Strain, Stratified by Prior Influenza Vaccination Status
GMFR: the geometric mean of the ratio of GMTs (Day 28/Day 0) measured using an MN assay for the strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Day 0 (pre-vaccination), Day 28
Number of Participants With at Least One Immediate AE, Stratified by Prior Influenza Vaccination Status
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. Immediate AEs were defined as any solicited (local and systemic) and unsolicited AEs that started up to 30 minutes after vaccination. Solicited local AEs included erythema, swelling and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck. It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Up to 30 minutes post-vaccination
Number of Participants With at Least One Immediate AE of Grade 1, 2, 3, or 4, Stratified by Prior Influenza Vaccination Status
An AE is defined in OM #6. Immediate AEs were defined as any solicited (local and systemic) and unsolicited AEs that started up to 30 minutes after vaccination. Solicited local AEs included erythema, swelling and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck. The intensity of the AEs was graded according to the FDA Toxicity Grading Scale: mild (Grade 1), moderate (Grade 2), severe (Grade 3), or potentially life threatening (Grade 4). It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Up to 30 minutes post-vaccination
Number of Participants With at Least One Immediate AE Related to Vaccination, Stratified by Prior Influenza Vaccination Status
An AE is defined in OM #6. Immediate AEs were defined as any solicited (local and systemic) and unsolicited AEs that started up to 30 minutes after vaccination. Solicited local AEs included erythema, swelling and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck. A related AE is an event where the investigator determined that the relationship to study vaccine was "Possibly Related", "Probably Related", or "Definitely Related". If a participant reported multiple occurrences of the same AE, only the most closely related occurrence was presented. It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Up to 30 minutes post-vaccination
Number of Participants With at Least One Solicited Local or Systemic AE, Stratified by Prior Influenza Vaccination Status
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. Solicited local AEs included erythema, swelling and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck. It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Day 0 (pre-vaccination) up to Day 7
Number of Participants With at Least One Solicited Local or Systemic AE of Grade 1, 2, 3, or 4, Stratified by Prior Influenza Vaccination Status
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. Solicited local AEs included erythema, swelling and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck. The intensity of the AEs was graded according to the FDA Toxicity Grading Scale: mild (Grade 1), moderate (Grade 2), severe (Grade 3), or potentially life threatening (Grade 4). It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Day 0 (pre-vaccination) up to Day 7
Number of Participants With at Least One Unsolicited AE, Stratified by Prior Influenza Vaccination Status
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Day 0 (pre-vaccination) up to Day 28
Number of Participants With at Least One Unsolicited AE of Grade 1, 2, 3, or 4, Stratified by Prior Influenza Vaccination Status
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. The intensity of the AEs was graded according to the FDA Toxicity Grading Scale: mild (Grade 1), moderate (Grade 2), severe (Grade 3), or potentially life threatening (Grade 4). It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Day 0 (pre-vaccination) up to Day 28
Number of Participants With at Least One Unsolicited AE Related to Vaccination, Stratified by Prior Influenza Vaccination Status
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. A related AE was an event where the Investigator determined that the relationship to study vaccine was "Possibly Related", "Probably Related", or "Definitely Related". It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Day 0 (pre-vaccination) up to Day 28
Number of Participants With at Least One SAE From Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365, Stratified by Prior Influenza Vaccination Status
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. An SAE is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event. It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365
Number of Participants With at Least One AE Leading to Withdrawal From the Study From Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365, Stratified by Prior Influenza Vaccination Status
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365
Number of Participants With at Least One AESI From Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365, Stratified by Prior Influenza Vaccination Status
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. AESIs included hypersensitivity reactions, narcolepsy, pIMDs, and other AESIs. It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365
Number of Participants With at Least One MAAE From Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365, Stratified by Prior Influenza Vaccination Status
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. MAAEs are defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider. It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365
Number of Participants With at Least One NOCD From Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365, Stratified by Prior Influenza Vaccination Status
All NOCDs that may plausibly have an allergic, autoimmune or inflammatory component were assessed and reported. Plausibility was interpreted broadly; the only clear exceptions were degenerative conditions such as osteoarthritis, age-related physiologic changes and life-style diseases. In this context, most cancers, cardiac conditions, and kidney diseases had to be reported. It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365
Number of Participants With the Occurrence of Death From Day 1 up to Day 28, From Day 29 to Day 182, and From Day 183 to Day 365, Stratified by Prior Influenza Vaccination Status
The number of participants in each treatment group with an occurrence of death was assessed. It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365
Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 0, Stratified by Prior Influenza Vaccination Status
Participants were monitored for abnormal findings in urine parameters (urine color, glucose, occult blood, protein, specific gravity, specimen appearance, pH), hematological parameters (basophils, leukocytes, eosinophils, erythrocytes mean corpuscular hemoglobin, erythrocytes, hematocrit, hemoglobin, lymphocytes, mean platelet volume, monocytes, neutrophils, platelets), and blood chemistry parameters (alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, calcium, chloride, cholesterol, creatinine, gamma glutamyl transferase, glucose, HDL and LDL cholesterol, phosphate, potassium, protein, sodium, triglycerides, urea nitrogen). Any laboratory result outside of the normal range was classified as "clinically significant" or "not clinically significant" by the site investigator. It was planned that the endpoint would be analyzed if >25% of the participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Day 0 (pre-vaccination)
Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 3, Stratified by Prior Influenza Vaccination Status
Participants were monitored for abnormal findings in urine parameters (urine color, glucose, occult blood, protein, specific gravity, specimen appearance, pH), hematological parameters (basophils, leukocytes, eosinophils, erythrocytes mean corpuscular hemoglobin, erythrocytes, hematocrit, hemoglobin, lymphocytes, mean platelet volume, monocytes, neutrophils, platelets), and blood chemistry parameters (alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, calcium, chloride, cholesterol, creatinine, gamma glutamyl transferase, glucose, HDL and LDL cholesterol, phosphate, potassium, protein, sodium, triglycerides, urea nitrogen). Any laboratory result outside of the normal range was classified as "clinically significant" or "not clinically significant" by the site investigator. It was planned that the endpoint would be analyzed if >25% of the participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Day 3
Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 28, Stratified by Prior Influenza Vaccination Status
Participants were monitored for abnormal findings in urine parameters (urine color, glucose, occult blood, protein, specific gravity, specimen appearance, pH), hematological parameters (basophils, leukocytes, eosinophils, erythrocytes mean corpuscular hemoglobin, erythrocytes, hematocrit, hemoglobin, lymphocytes, mean platelet volume, monocytes, neutrophils, platelets), and blood chemistry parameters (alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, calcium, chloride, cholesterol, creatinine, gamma glutamyl transferase, glucose, HDL and LDL cholesterol, phosphate, potassium, protein, sodium, triglycerides, urea nitrogen). Any laboratory result outside of the normal range was classified as "clinically significant" or "not clinically significant" by the site investigator. It was planned that the endpoint would be analyzed if >25% of the participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
Day 28
Chandler
Arizona
85224
United States
Optimal Sites
San Diego
California
92108
United States
Optimal Sites
Melbourne
Florida
32934-8172
United States
Global AES
Orlando
Florida
32806
United States
Global AES
The Villages
Florida
32162-7116
United States
Optimal Sites
Peoria
Illinois
61614
United States
Synexus
Evansville
Indiana
47714-7513
United States
Optimal Sites
Rockville
Maryland
20850
United States
Vitalink Research
Anderson
South Carolina
29621
United States
Vitalink Research
Columbia
South Carolina
29204
United States
Vitalink Research
Gaffney
South Carolina
29340
United States
Vitalink Research
Union
South Carolina
29379
United States
Optimal Sites
Austin
Texas
78705-2655
United States
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
FG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
FG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
FG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
FG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
FG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
FG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone high dose (HD) Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible)
FG00019 subjects
FG0019 subjects
FG00242 subjects
FG00319 subjects
FG00423 subjects
FG00513 subjects
FG00641 subjects
FG00743 subjects
Vaccinated
FG00019 subjects
FG0019 subjects
FG00242 subjects
FG00319 subjects
FG00423 subjects
FG00513 subjects
FG00641 subjects
FG00743 subjects
COMPLETED
FG00018 subjects
FG0019 subjects
FG00238 subjects
FG00316 subjects
FG00421 subjects
FG00513 subjects
FG00638 subjects
FG00736 subjects
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0024 subjects
FG0033 subjects
FG0042 subjects
FG0050 subjects
FG0063 subjects
FG0077 subjects
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0033 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG004
Other than specified above
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Safety Analysis Ser (SAS) was defined as all participants who received either the adjuvanted QVLP or the active comparators.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
BG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
BG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
BG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
BG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
BG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
BG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible)..
BG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00019
BG0019
BG00242
BG00319
BG00423
BG00513
BG00641
BG00743
BG008209
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
65-74 years
Title
Measurements
BG00014
BG0017
BG00233
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0008
BG0016
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0003
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Immunization History
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Both Influenza and Non-influenza
BG0001
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous Influenza Strain on Day 0
The GMTs in each treatment group were measured using an HI assay for the homologous influenza strains: A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage).
Per protocol (PP) set included participants with a Day 0 and any post-vaccination immunogenicity assessment who completed the study with no major protocol deviations related to participant eligibility, the ability to develop a valid immune response, prohibited medication use, or the immunogenicity analyses; and who received QVLP or the active comparators.
Posted
Geometric Mean
95% Confidence Interval
titers
Day 0 (pre-vaccination)
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG00019
OG0019
OG00238
OG003
Title
Denominators
Categories
H1N1
Title
Measurements
OG00087.5704(54.8902 to 139.7076)
OG00171.2385(36.1378 to 140.4323)
OG00269.1840(49.7233 to 96.2612)
Primary
GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 28
The GMTs in each treatment group were measured using an HI assay for the homologous influenza strains: A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage).
Participants in PP Set with available data were analyzed.
Posted
Geometric Mean
95% Confidence Interval
titers
Day 28
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
Primary
Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28
Seroconversion rate: the percentage of participants in a given treatment group with either a ≥4-fold increase in reciprocal HI titers between Day 0 and Day 28 or a rise of undetectable HI titer (i.e. < 10) pre-vaccination (Day 0) to an HI titer of ≥ 40 on Day 28 was measured using an HI assay for the homologous influenza strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage).
Participants in PP Set with available data were analyzed.
Posted
Number
95% Confidence Interval
percentage of participants
Day 0 (pre-vaccination) up to Day 28
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
QVLP30+Full AS03
Primary
Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 28
Seroprotection rate: the percentage of participants in a given treatment group attaining a reciprocal HI titer of ≥40 on Day 28 (the percentage of vaccine recipients with a serum HI titer of at least 1:40 following vaccination) for the homologous influenza strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage).
Participants in PP Set with available data were analyzed.
Posted
Number
95% Confidence Interval
percentage of participants
Day 0 (pre-vaccination) up to Day 28
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
QVLP30+Full AS03
Primary
Geometric Mean Fold Rise (GMFR) Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 28/Day 0)
GMFR, the geometric mean of the ratio of GMTs (Day 28/Day 0) in each treatment group was measured using an HI assay for the homologous strains: A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage).
Participants in PP Set with available data were analyzed.
Posted
Geometric Mean
95% Confidence Interval
ratio
Day 0 (pre-vaccination), Day 28
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
Primary
Number of Participants With at Least One Immediate Adverse Event (AE)
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. Immediate AEs were defined as any solicited (local and systemic) and unsolicited AEs that started up to 30 minutes after vaccination. Solicited local AEs included erythema, swelling, and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck.
SAS.
Posted
Count of Participants
Participants
Up to 30 minutes post-vaccination
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
Primary
Number of Participants With at Least One Immediate AE of Grade 1, 2, 3, or 4
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. Immediate AEs were defined as any solicited (local and systemic) and unsolicited AEs that started up to 30 minutes after vaccination. Solicited local AEs included erythema, swelling, and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck. The intensity of the AEs was graded according to the United States Food and Drug Administration Toxicity Grading Scale: mild (Grade 1), moderate (Grade 2), severe (Grade 3), or potentially life threatening (Grade 4).
Participants in SAS with at least one immediate AE.
Posted
Count of Participants
Participants
Up to 30 minutes post-vaccination
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Primary
Number of Participants With at Least One Immediate AE Related to Vaccination
An AE is defined in OM #6. Immediate AEs were defined as any solicited (local and systemic) and unsolicited AEs that started up to 30 minutes after vaccination. Solicited local AEs included erythema, swelling and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck. A related AE is an event where the investigator determined that the relationship to study vaccine was "Possibly Related", "Probably Related" or "Definitely Related". If a participant reported multiple occurrences of the same AE, only the most closely related occurrence was presented. The causal relationship of all solicited local and systemic AEs was considered related to vaccination. Participants with any related AE was reported.
Participants in SAS with at least one immediate AE.
Posted
Count of Participants
Participants
30 minutes post-vaccination
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
Primary
Number of Participants With at Least One Solicited Local or Systemic AE From Day 0 up to Day 7
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. Solicited local AEs included erythema, swelling, and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck.
SAS.
Posted
Count of Participants
Participants
Day 0 (pre-vaccination) up to Day 7
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
Primary
Number of Participants With at Least One Solicited Local or Systemic AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 7
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. Solicited local AEs included erythema, swelling and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck. The intensity of the AEs was graded according to the FDA Toxicity Grading Scale: mild (Grade 1), moderate (Grade 2), severe (Grade 3), or potentially life threatening (Grade 4).
Participants in SAS with at least one solicited local or systemic AE.
Posted
Count of Participants
Participants
Day 0 (pre-vaccination) up to Day 7
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
Primary
Number of Participants With at Least One Unsolicited AE From Day 0 up to Day 28
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product.
SAS.
Posted
Count of Participants
Participants
Day 0 (pre-vaccination) up to Day 28
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
Primary
Number of Participants With at Least One Unsolicited AE of Grade 1, 2, 3, or 4 From Day 0 up to Day 28
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. The intensity of the AEs was graded according to the FDA Toxicity Grading Scale: mild (Grade 1), moderate (Grade 2), severe (Grade 3), or potentially life threatening (Grade 4).
Participants in SAS with at least one unsolicited AE.
Posted
Count of Participants
Participants
Day 0 (pre-vaccination) up to Day 28
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
QVLP30+Full AS03
Primary
Number of Participants With at Least One Unsolicited AE Related to Vaccination From Day 0 up to Day 28
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. A related AE was an event where the Investigator determined that the relationship to study vaccine was "Possibly Related", "Probably Related" or "Definitely Related". If a participant reported multiple occurrences of the same AE, only the most closely related occurrence was presented. Participants with any related AE were reported.
Participants in SAS with at least one unsolicited AE.
Posted
Count of Participants
Participants
Day 0 (pre-vaccination) up to Day 28
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
Primary
Number of Participants With at Least One Serious Adverse Events (SAE) From Day 1 up to Day 28
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. An SAE is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event.
SAS.
Posted
Count of Participants
Participants
Day 1 up to Day 28
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
QVLP30+Full AS03
Primary
Number of Participants With at Least One AE Leading to Withdrawal From the Study From Day 1 up to Day 28
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product.
SAS.
Posted
Count of Participants
Participants
Day 1 up to Day 28
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
Primary
Number of Participants With at Least One Adverse Event of Special Interest (AESI) From Day 1 up to Day 28
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. AESIs included hypersensitivity reactions, narcolepsy, Potential Immune-Mediated Diseases (pIMDs), and other AESIs. Participants with any AESI were reported.
SAS.
Posted
Count of Participants
Participants
Day 1 up to Day 28
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
QVLP30+Full AS03
Primary
Number of Participants With at Least One Medically Attended AE (MAAE) From Day 1 up to Day 28
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. MAAEs are defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a healthcare provider.
SAS.
Posted
Count of Participants
Participants
Day 1 up to Day 28
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
Primary
Number of Participants With at Least One New Onset Clinical Disease (NOCD) From Day 1 up to Day 28
All NOCDs that may plausibly have an allergic, autoimmune or inflammatory component were assessed and reported. Plausibility was interpreted broadly; the only clear exceptions were degenerative conditions such as osteoarthritis, age-related physiologic changes and life-style diseases. In this context, most cancers, cardiac conditions, and kidney diseases had to be reported.
SAS.
Posted
Count of Participants
Participants
Day 1 up to Day 28
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
Primary
Number of Participants With the Occurrence of Death From Day 1 up to Day 28
The number of participants in each treatment group with an occurrence of death was assessed.
SAS.
Posted
Count of Participants
Participants
Day 1 up to Day 28
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Primary
Number of Participants With at Least One SAE From Day 29 up to Day 182
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. An SAE is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event.
SAS.
Posted
Count of Participants
Participants
Day 29 up to Day 182
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
QVLP30+Full AS03
Primary
Number of Participants With at Least One AE Leading to Withdrawal From the Study From Day 29 up to Day 182
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. The number of participants with at least one AE leading to withdrawal was assessed.
SAS.
Posted
Count of Participants
Participants
Day 29 up to Day 182
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
Primary
Number of Participants With at Least One AESI From Day 29 up to Day 182
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. AESIs included hypersensitivity reactions, narcolepsy, pIMDs, and other AESIs. Participants with any AESI were reported.
SAS.
Posted
Count of Participants
Participants
Day 29 up to Day 182
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
Primary
Number of Participants With at Least One MAAE From Day 29 up to Day 182
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. MAAEs are defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider.
SAS.
Posted
Count of Participants
Participants
Day 29 up to Day 182
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
Primary
Number of Participants With at Least One New NOCD From Day 29 up to Day 182
All NOCDs that may plausibly have an allergic, autoimmune or inflammatory component were assessed and reported. Plausibility was interpreted broadly; the only clear exceptions were degenerative conditions such as osteoarthritis, age-related physiologic changes and life-style diseases. In this context, most cancers, cardiac conditions, and kidney diseases were reported.
SAS.
Posted
Count of Participants
Participants
Day 29 up to Day 182
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
Primary
Number of Participants With an Occurrence of Death From Day 29 up to Day 182
The number of participants in each treatment group with an occurrence of death was assessed.
SAS.
Posted
Count of Participants
Participants
Day 29 up to Day 182
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Primary
Number of Participants With at Least One SAE From Day 183 up to Day 365
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. An SAE is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event.
SAS.
Posted
Count of Participants
Participants
Day 183 up to the end of study (Day 365)
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
QVLP30+Full AS03
Primary
Number of Participants With at Least One AE Leading to Withdrawal From the Study From Day 183 up to Day 365
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. The number of participants with at least one AE leading to withdrawal was assessed.
SAS.
Posted
Count of Participants
Participants
Day 183 up to the end of study (Day 365)
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
Primary
Number of Participants With at Least One AESI From Day 183 up to Day 365
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. AESIs included hypersensitivity reactions, narcolepsy, pIMDs, and other AESIs. Participants with any AESI were reported.
SAS.
Posted
Count of Participants
Participants
Day 183 up to the end of study (Day 365)
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
Primary
Number of Participants With at Least One MAAE From Day 183 up to Day 365
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. MAAEs were defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider.
SAS.
Posted
Count of Participants
Participants
Day 183 up to the end of study (Day 365)
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
QVLP30+Full AS03
Primary
Number of Participants With at Least One NOCD From Day 183 up to Day 365
All NOCDs that may plausibly have an allergic, autoimmune or inflammatory component were assessed and reported. Plausibility should be interpreted broadly; the only clear exceptions are degenerative conditions such as osteoarthritis, age-related physiologic changes and life-style diseases. In this context, most cancers, cardiac conditions, and kidney diseases should be reported.
SAS.
Posted
Count of Participants
Participants
Day 183 up to the end of study (Day 365)
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
Primary
Number of Participants With an Occurrence of Death From Day 183 up to Day 365
The number of participants in each treatment group with an occurrence of death was assessed.
SAS.
Posted
Count of Participants
Participants
Day 183 up to the end of study (Day 365)
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Primary
Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 0
Participants were monitored for any abnormal findings in urine parameters (urine color, glucose, occult blood, protein, specific gravity, specimen appearance, pH), hematological parameters (basophils, leukocytes, eosinophils, erythrocytes mean corpuscular hemoglobin, erythrocytes, hematocrit, hemoglobin, lymphocytes, mean platelet volume, monocytes, neutrophils, platelets), and blood chemistry parameters (alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, calcium, chloride, cholesterol, creatinine, gamma glutamyl transferase, glucose, HDL and LDL cholesterol, phosphate, potassium, protein, sodium, triglycerides, urea nitrogen). Any laboratory result outside of the testing laboratory's normal range was classified as "clinically significant" or "not clinically significant" by the site investigator, with appropriate documentation.
SAS. Only participants with at least one clinically significant laboratory parameter are reported.
Posted
Count of Participants
Participants
Day 0 (pre-vaccination)
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Primary
Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 3
Participants were monitored for any abnormal findings in urine parameters (urine color, glucose, occult blood, protein, specific gravity, specimen appearance, pH), hematological parameters (basophils, leukocytes, eosinophils, erythrocytes mean corpuscular hemoglobin, erythrocytes, hematocrit, hemoglobin, lymphocytes, mean platelet volume, monocytes, neutrophils, platelets), and blood chemistry parameters (alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, calcium, chloride, cholesterol, creatinine, gamma glutamyl transferase, glucose, HDL and LDL cholesterol, phosphate, potassium, protein, sodium, triglycerides, urea nitrogen). Any laboratory result outside of the testing laboratory's normal range was classified as "clinically significant" or "not clinically significant" by the site investigator, with appropriate documentation.
SAS. Only participants with at least one clinically significant abnormal laboratory finding are reported.
Posted
Count of Participants
Participants
Day 3
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Primary
Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 28
Participants were monitored for any abnormal findings in urine parameters (urine color, glucose, occult blood, protein, specific gravity, specimen appearance, and pH), hematological parameters (basophils, leukocytes, eosinophils, erythrocytes mean corpuscular hemoglobin, erythrocytes, hematocrit, hemoglobin, lymphocytes, mean platelet volume, monocytes, neutrophils, and platelets), and blood chemistry parameters (alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, calcium, chloride, cholesterol, creatinine, gamma glutamyl transferase, glucose, cholesterol, phosphate, potassium, protein, sodium, triglycerides, and urea nitrogen). Any laboratory result outside of the testing laboratory's normal range was classified as "clinically significant" or "not clinically significant" by the site investigator, with appropriate documentation.
SAS. Only participants with at least one clinically significant abnormal laboratory finding are reported.
Posted
Count of Participants
Participants
Day 28
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Secondary
GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365
The GMTs in each treatment group were measured using an HI assay for the homologous influenza strains: A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage).
Participants in PP Set with available data at each time point were analyzed.
Posted
Geometric Mean
95% Confidence Interval
titers
Day 182, Day 365
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
Secondary
Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365
Seroconversion rate: the percentage of participants in a given treatment group with either a ≥4-fold increase in reciprocal HI titers between Day 0 and Day 182 and Day 0 and Day 365 or a rise of undetectable HI titer (i.e. <10) pre-vaccination (Day 0) to an HI titer of ≥40 on Day 182 and Day 365 was measured using an HI assay for the following homologous influenza strains: A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage).
Participants in PP Set with available data at each timepoint were analyzed.
Posted
Number
95% Confidence Interval
percentage of participants
Day 0 (pre-vaccination) up to Day 182 and up to Day 365
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
Secondary
Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain on Day 182 and Day 365
Seroprotection rate: the percentage of participants in a given treatment group attaining a reciprocal HI titer of ≥40 on Day 182 and on Day 365 (the percentage of vaccine recipients with a serum HI titer of at least 1:40 following vaccination) for the homologous influenza strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage)
Participants in PP Set with available data at each timepoint were analyzed.
Posted
Number
95% Confidence Interval
percentage of participants
Day 0 (pre-vaccination) up to Day 182 and up to Day 365
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
QVLP30+Full AS03
Secondary
GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0)
GMFR: the geometric mean of the ratio of GMTs (Day 182/Day 0 and Day 365/Day 0) measured using an HI assay for the homologous strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage).
Participants in PP Set with available data at each timepoint were analyzed.
Posted
Geometric Mean
95% Confidence Interval
ratio
Day 0 (pre-vaccination), Day 182, Day 365
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
Secondary
GMTs of HI Antibody Response for Each Heterologous Influenza Strain
The GMTs in each treatment group were measured using an HI assay for the heterologous influenza strains: A/Brisbane/02/2018 (H1N1), A/Kansas/14/2017 (H3N2), and B/Maryland/15/2016 (B/Victoria lineage).
Participants in PP Set with available data were analyzed.
Posted
Geometric Mean
95% Confidence Interval
titers
Day 0 (pre-vaccination), Day 28
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
Secondary
Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Heterologous Influenza Strain
Seroconversion rate: the percentage of participants in a given treatment group with either a ≥4-fold increase in reciprocal HI titers between Day 0 and Day 28 or a rise of undetectable HI titer (i.e. <10) pre-vaccination (Day 0) to an HI titer of ≥40 on Day 28 was measured using an HI assay for the heterologous influenza strains A/Brisbane/02/2018 (H1N1), A/Kansas/14/2017 (H3N2), and B/Maryland/15/2016 (B/Victoria lineage).
Participants in PP Set with available data were analyzed.
Posted
Number
95% Confidence Interval
percentage of participants
Day 0 (pre-vaccination) up to Day 28
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
QVLP30+Full AS03
Secondary
Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Heterologous Influenza Strain
Seroprotection rate: the percentage of participants in a given treatment group attaining a reciprocal HI titer of ≥40 on Day 28 (the percentage of vaccine recipients with a serum HI titer of at least 1:40 following vaccination) for the heterologous influenza strains A/Brisbane/02/2018 (H1N1), A/Kansas/14/2017 (H3N2), and B/Maryland/15/2016 (B/Victoria lineage)
Participants in PP Set with available data were analyzed.
Posted
Number
95% Confidence Interval
percentage of participants
Day 0 (pre-vaccination) up to Day 28
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
Secondary
GMFR Measured by HI Antibody Response for Each Heterologous Influenza Strain
GMFR: the geometric mean of the ratio of GMTs (Day 28/Day 0) measured using an HI assay for the heterologous strains A/Brisbane/02/2018 (H1N1), A/Kansas/14/2017 (H3N2), and B/Maryland/15/2016 (B/Victoria lineage).
Participants in PP Set with available data were analyzed.
Posted
Geometric Mean
95% Confidence Interval
ratio
Day 0 (pre-vaccination), Day 28
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
Secondary
GMTs of Microneutralization (MN) Antibody Response for Each Homologous Influenza Strain
The GMTs in each treatment group were measured using an MN assay for the homologous influenza strains: A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage).
Participants in PP Set with available data were analyzed.
Posted
Geometric Mean
95% Confidence Interval
titers
Day 0 (pre-vaccination), Day 28
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
Secondary
Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Influenza Strain
Seroconversion rate: the percentage of participants in a given treatment group with either a ≥4-fold increase in reciprocal HI titers between Day 0 and Day 28 or a rise of undetectable MN titer (i.e. <10) pre-vaccination (Day 0) to an MN titer of ≥40 on Day 28 was measured using an MN assay for the homologous influenza strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage).
Participants in PP Set with available data were analyzed.
Posted
Number
95% Confidence Interval
percentage of participants
Day 0 (pre-vaccination) up to Day 28
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
QVLP30+Full AS03
Secondary
GMFR Measured by MN Antibody Response for Each Homologous Influenza Strain
GMFR: the geometric mean of the ratio of GMTs (Day 28/Day 0) measured using an MN assay for the homologous strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage).
Participants in PP Set with available data were analyzed.
Posted
Geometric Mean
95% Confidence Interval
ratio
Day 0 (pre-vaccination), Day 28
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
Secondary
GMTs of HI Antibody Response for Each Homologous Influenza Strain, Stratified by Prior Influenza Vaccination Status
The GMTs in each treatment group were measured using an HI assay for the homologous influenza strains: A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Posted
Day 0 (pre-vaccination), Day 28
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
QVLP30+Full AS03
Secondary
Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous Influenza Strain, Stratified by Prior Influenza Vaccination Status
Seroconversion rate: the percentage of participants in a given treatment group with either a ≥4-fold increase in reciprocal HI titers between Day 0 and Day 28 or a rise of undetectable HI titer (i.e. <10) pre-vaccination (Day 0) to an HI titer of ≥40 on Day 28 was measured using an HI assay for the homologous influenza strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Posted
Day 0 (pre-vaccination) up to Day 28
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
Secondary
Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous Influenza Strain, Stratified by Prior Influenza Vaccination Status
Seroprotection rate: the percentage of participants in a given treatment group attaining a reciprocal HI titer of ≥40 on Day 28 (the percentage of vaccine recipients with a serum HI titer of at least 1:40 following vaccination) for the homologous influenza strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Posted
Day 0 (pre-vaccination) up to Day 28
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
Secondary
GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain, Stratified by Prior Influenza Vaccination Status
GMFR: the geometric mean of the ratio of GMTs (Day 28/Day 0) measured using an HI assay for the homologous strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Posted
Day 0 (pre-vaccination), Day 28
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
Secondary
GMTs of HI Antibody Response for Each Heterologous Influenza Strain, Stratified by Prior Influenza Vaccination Status
The GMTs in each treatment group were measured using an HI assay for the heterologous influenza strains: A/Brisbane/02/2018 (H1N1), A/Kansas/14/2017 (H3N2), and B/Maryland/15/2016 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination. It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
The analysis were not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Posted
Day 0 (pre-vaccination), Day 28
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
Secondary
Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Heterologous Influenza Strain, Stratified by Prior Influenza Vaccination Status
Seroconversion rate: the percentage of participants in a given treatment group with either a ≥4-fold increase in reciprocal HI titers between Day 0 and Day 28 or a rise of undetectable HI titer (i.e. <10) pre-vaccination (Day 0) to an HI titer of ≥40 on Day 28 was measured using an HI assay for the following heterologous influenza strains: A/Brisbane/02/2018 (H1N1), A/Kansas/14/2017 (H3N2), and B/Maryland/15/2016 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Posted
Day 0 (pre-vaccination) up to Day 28
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
Secondary
Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Heterologous Influenza Strain, Stratified by Prior Influenza Vaccination Status
Seroprotection rate: the percentage of participants in a given treatment group attaining a reciprocal HI titer of ≥40 on Day 28 (the percentage of vaccine recipients with a serum HI titer of at least 1:40 following vaccination) for the following heterologous influenza strains: A/Brisbane/02/2018 (H1N1), A/Kansas/14/2017 (H3N2), and B/Maryland/15/2016 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Posted
Day 0 (pre-vaccination) up to Day 28
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
Secondary
GMFR Measured by HI Antibody Response for Each Heterologous Influenza Strain, Stratified by Prior Influenza Vaccination Status
GMFR: the geometric mean of the ratio of GMTs (Day 28/Day 0) measured using an HI assay for the heterologous strains A/Brisbane/02/2018 (H1N1), A/Kansas/14/2017 (H3N2), and B/Maryland/15/2016 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Posted
Day 0 (pre-vaccination), Day 28
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
QVLP30+Full AS03
Secondary
GMTs of MN Antibody Response for Each Homologous Influenza Strain, Stratified by Prior Influenza Vaccination Status
The GMTs in each treatment group were measured using an MN assay for the following homologous influenza strains: A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Posted
Day 0 (pre-vaccination), Day 28
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
QVLP30+Full AS03
Secondary
Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Influenza Strain, Stratified by Prior Influenza Vaccination Status
Seroconversion rate: the percentage of participants in a given treatment group with either a ≥4-fold increase in reciprocal HI titers between Day 0 and Day 28 or a rise of undetectable MN titer (i.e. <10) pre-vaccination (Day 0) to an MN titer of ≥40 on Day 28 was measured using an MN assay for the homologous influenza strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Posted
Day 0 (pre-vaccination) up to Day 28
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
Secondary
GMFR Measured by MN Antibody Response for Each Homologous Influenza Strain, Stratified by Prior Influenza Vaccination Status
GMFR: the geometric mean of the ratio of GMTs (Day 28/Day 0) measured using an MN assay for the strains A/Hawaii/70/2019 (H1N1), A/Minnesota/41/2019 (H3N2), B/Singapore/INFKK-16-0569/2016 (B/Yamagata lineage), and B/Washington/02/2019 (B/Victoria lineage). It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Posted
Day 0 (pre-vaccination), Day 28
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
QVLP30+Full AS03
Secondary
Number of Participants With at Least One Immediate AE, Stratified by Prior Influenza Vaccination Status
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. Immediate AEs were defined as any solicited (local and systemic) and unsolicited AEs that started up to 30 minutes after vaccination. Solicited local AEs included erythema, swelling and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck. It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Posted
Up to 30 minutes post-vaccination
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Secondary
Number of Participants With at Least One Immediate AE of Grade 1, 2, 3, or 4, Stratified by Prior Influenza Vaccination Status
An AE is defined in OM #6. Immediate AEs were defined as any solicited (local and systemic) and unsolicited AEs that started up to 30 minutes after vaccination. Solicited local AEs included erythema, swelling and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck. The intensity of the AEs was graded according to the FDA Toxicity Grading Scale: mild (Grade 1), moderate (Grade 2), severe (Grade 3), or potentially life threatening (Grade 4). It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Posted
Up to 30 minutes post-vaccination
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
Secondary
Number of Participants With at Least One Immediate AE Related to Vaccination, Stratified by Prior Influenza Vaccination Status
An AE is defined in OM #6. Immediate AEs were defined as any solicited (local and systemic) and unsolicited AEs that started up to 30 minutes after vaccination. Solicited local AEs included erythema, swelling and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck. A related AE is an event where the investigator determined that the relationship to study vaccine was "Possibly Related", "Probably Related", or "Definitely Related". If a participant reported multiple occurrences of the same AE, only the most closely related occurrence was presented. It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Posted
Up to 30 minutes post-vaccination
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Secondary
Number of Participants With at Least One Solicited Local or Systemic AE, Stratified by Prior Influenza Vaccination Status
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. Solicited local AEs included erythema, swelling and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck. It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Posted
Day 0 (pre-vaccination) up to Day 7
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
Secondary
Number of Participants With at Least One Solicited Local or Systemic AE of Grade 1, 2, 3, or 4, Stratified by Prior Influenza Vaccination Status
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. Solicited local AEs included erythema, swelling and pain at the injection site. Solicited systemic AEs included fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck. The intensity of the AEs was graded according to the FDA Toxicity Grading Scale: mild (Grade 1), moderate (Grade 2), severe (Grade 3), or potentially life threatening (Grade 4). It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Posted
Day 0 (pre-vaccination) up to Day 7
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
Secondary
Number of Participants With at Least One Unsolicited AE, Stratified by Prior Influenza Vaccination Status
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Posted
Day 0 (pre-vaccination) up to Day 28
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
Secondary
Number of Participants With at Least One Unsolicited AE of Grade 1, 2, 3, or 4, Stratified by Prior Influenza Vaccination Status
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. The intensity of the AEs was graded according to the FDA Toxicity Grading Scale: mild (Grade 1), moderate (Grade 2), severe (Grade 3), or potentially life threatening (Grade 4). It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Posted
Day 0 (pre-vaccination) up to Day 28
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
Secondary
Number of Participants With at Least One Unsolicited AE Related to Vaccination, Stratified by Prior Influenza Vaccination Status
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. A related AE was an event where the Investigator determined that the relationship to study vaccine was "Possibly Related", "Probably Related", or "Definitely Related". It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Posted
Day 0 (pre-vaccination) up to Day 28
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
Secondary
Number of Participants With at Least One SAE From Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365, Stratified by Prior Influenza Vaccination Status
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. An SAE is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event. It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Posted
Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Secondary
Number of Participants With at Least One AE Leading to Withdrawal From the Study From Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365, Stratified by Prior Influenza Vaccination Status
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Posted
Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
Secondary
Number of Participants With at Least One AESI From Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365, Stratified by Prior Influenza Vaccination Status
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. AESIs included hypersensitivity reactions, narcolepsy, pIMDs, and other AESIs. It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Posted
Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
Secondary
Number of Participants With at Least One MAAE From Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365, Stratified by Prior Influenza Vaccination Status
An AE is defined as any untoward medical occurrence in a participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. MAAEs are defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider. It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Posted
Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
Secondary
Number of Participants With at Least One NOCD From Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365, Stratified by Prior Influenza Vaccination Status
All NOCDs that may plausibly have an allergic, autoimmune or inflammatory component were assessed and reported. Plausibility was interpreted broadly; the only clear exceptions were degenerative conditions such as osteoarthritis, age-related physiologic changes and life-style diseases. In this context, most cancers, cardiac conditions, and kidney diseases had to be reported. It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Posted
Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
Secondary
Number of Participants With the Occurrence of Death From Day 1 up to Day 28, From Day 29 to Day 182, and From Day 183 to Day 365, Stratified by Prior Influenza Vaccination Status
The number of participants in each treatment group with an occurrence of death was assessed. It was planned that the endpoint would be analyzed only if >25% of the enrolled participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Posted
Day 1 up to Day 28, Day 29 up to Day 182, and Day 183 up to Day 365
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
QVLP30+Full AS03
Secondary
Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 0, Stratified by Prior Influenza Vaccination Status
Participants were monitored for abnormal findings in urine parameters (urine color, glucose, occult blood, protein, specific gravity, specimen appearance, pH), hematological parameters (basophils, leukocytes, eosinophils, erythrocytes mean corpuscular hemoglobin, erythrocytes, hematocrit, hemoglobin, lymphocytes, mean platelet volume, monocytes, neutrophils, platelets), and blood chemistry parameters (alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, calcium, chloride, cholesterol, creatinine, gamma glutamyl transferase, glucose, HDL and LDL cholesterol, phosphate, potassium, protein, sodium, triglycerides, urea nitrogen). Any laboratory result outside of the normal range was classified as "clinically significant" or "not clinically significant" by the site investigator. It was planned that the endpoint would be analyzed if >25% of the participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Posted
Day 0 (pre-vaccination)
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
Secondary
Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 3, Stratified by Prior Influenza Vaccination Status
Participants were monitored for abnormal findings in urine parameters (urine color, glucose, occult blood, protein, specific gravity, specimen appearance, pH), hematological parameters (basophils, leukocytes, eosinophils, erythrocytes mean corpuscular hemoglobin, erythrocytes, hematocrit, hemoglobin, lymphocytes, mean platelet volume, monocytes, neutrophils, platelets), and blood chemistry parameters (alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, calcium, chloride, cholesterol, creatinine, gamma glutamyl transferase, glucose, HDL and LDL cholesterol, phosphate, potassium, protein, sodium, triglycerides, urea nitrogen). Any laboratory result outside of the normal range was classified as "clinically significant" or "not clinically significant" by the site investigator. It was planned that the endpoint would be analyzed if >25% of the participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Posted
Day 3
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
Secondary
Number of Participants With Clinically Significant Abnormal Urine, Hematological, and Blood Biochemistry Values on Day 28, Stratified by Prior Influenza Vaccination Status
Participants were monitored for abnormal findings in urine parameters (urine color, glucose, occult blood, protein, specific gravity, specimen appearance, pH), hematological parameters (basophils, leukocytes, eosinophils, erythrocytes mean corpuscular hemoglobin, erythrocytes, hematocrit, hemoglobin, lymphocytes, mean platelet volume, monocytes, neutrophils, platelets), and blood chemistry parameters (alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, calcium, chloride, cholesterol, creatinine, gamma glutamyl transferase, glucose, HDL and LDL cholesterol, phosphate, potassium, protein, sodium, triglycerides, urea nitrogen). Any laboratory result outside of the normal range was classified as "clinically significant" or "not clinically significant" by the site investigator. It was planned that the endpoint would be analyzed if >25% of the participants had received a standard influenza vaccine during the 12 months prior to study vaccination.
The analysis was not performed because less than 25% of the enrolled participants had received a standard influenza vaccine during the last 12 months prior to study vaccination.
Posted
Day 28
ID
Title
Description
OG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
Time Frame
Day 0 (post-vaccination) to Day 365 (end of study)
Description
SAS. The unsolicited SAEs, unsolicited non-serious AEs, and all deaths were reported.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
QVLP15+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
0
19
1
19
10
19
EG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
0
9
2
9
5
9
EG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
1
42
6
42
19
42
EG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
0
19
2
19
6
19
EG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
0
23
1
23
5
23
EG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
0
13
0
13
4
13
EG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
0
41
1
41
18
41
EG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
1
43
5
43
16
43
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
COVID-19
Infections and infestations
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0021 affected42 at risk
EG0030 affected19 at risk
EG0040 affected23 at risk
EG0050 affected13 at risk
EG0060 affected41 at risk
EG0071 affected43 at risk
COVID-19 pneumonia
Infections and infestations
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0021 affected42 at risk
EG003
Pneumonia
Infections and infestations
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected9 at risk
EG0020 affected42 at risk
EG003
Pneumonia aspiration
Infections and infestations
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0021 affected42 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0021 affected42 at risk
EG003
Urosepsis
Infections and infestations
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0021 affected42 at risk
EG003
Blood loss anaemia
Blood and lymphatic system disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected9 at risk
EG0020 affected42 at risk
EG003
Alcohol abuse
Psychiatric disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0021 affected42 at risk
EG003
Generalised tonic-clonic seizure
Nervous system disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0021 affected42 at risk
EG003
Syncope
Nervous system disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0021 affected42 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0021 affected42 at risk
EG003
Aortic stenosis
Vascular disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected9 at risk
EG0020 affected42 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA Version 25.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0021 affected42 at risk
EG003
Colitis ischaemic
Gastrointestinal disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Cervical vertebral fracture
Injury, poisoning and procedural complications
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected9 at risk
EG0020 affected42 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Asymptomatic COVID-19
Infections and infestations
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0021 affected42 at risk
EG0030 affected19 at risk
EG0040 affected23 at risk
EG0050 affected13 at risk
EG0060 affected41 at risk
EG0070 affected43 at risk
Bronchitis
Infections and infestations
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
COVID-19
Infections and infestations
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0021 affected42 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Cellulitis
Infections and infestations
MedDRA Version 25.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0021 affected42 at risk
EG003
Coccidioidomycosis
Infections and infestations
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Cystitis
Infections and infestations
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Escherichia urinary tract infection
Infections and infestations
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0021 affected42 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA Version 25.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected9 at risk
EG0021 affected42 at risk
EG003
Infection parasitic
Infections and infestations
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0021 affected42 at risk
EG003
Influenza
Infections and infestations
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Pneumonia
Infections and infestations
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Sinusitis
Infections and infestations
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0021 affected42 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0021 affected42 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA Version 25.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected9 at risk
EG0025 affected42 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0021 affected42 at risk
EG003
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0021 affected42 at risk
EG003
Malignant melanoma in situ
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0021 affected42 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0021 affected42 at risk
EG003
Normocytic anaemia
Blood and lymphatic system disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0021 affected42 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected9 at risk
EG0020 affected42 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0021 affected42 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0021 affected42 at risk
EG003
Hypochloraemia
Metabolism and nutrition disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected9 at risk
EG0020 affected42 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected9 at risk
EG0022 affected42 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0021 affected42 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected9 at risk
EG0020 affected42 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA Version 25.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected9 at risk
EG0020 affected42 at risk
EG003
Depression
Psychiatric disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0021 affected42 at risk
EG003
Nightmare
Psychiatric disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Cervical radiculopathy
Nervous system disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0021 affected42 at risk
EG003
Dementia Alzheimer's type
Nervous system disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Headache
Nervous system disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0021 affected42 at risk
EG003
Presyncope
Nervous system disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0021 affected42 at risk
EG003
Cataract
Eye disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0022 affected42 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Arteriosclerosis coronary artery
Cardiac disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0022 affected42 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Hypertension
Vascular disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Allergic sinusitis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0021 affected42 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA Version 25.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected9 at risk
EG0021 affected42 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA Version 25.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA Version 25.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Diverticulum
Gastrointestinal disorders
MedDRA Version 25.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0021 affected42 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0024 affected42 at risk
EG003
Gingival recession
Gastrointestinal disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA Version 25.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0021 affected42 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
MedDRA Version 25.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Retching
Gastrointestinal disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0021 affected42 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0021 affected42 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA Version 25.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0022 affected42 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Intervertebral disc degeneration
Musculoskeletal and connective tissue disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0021 affected42 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Muscle twitching
Musculoskeletal and connective tissue disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected9 at risk
EG0020 affected42 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA Version 25.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected9 at risk
EG0020 affected42 at risk
EG003
Synovial cyst
Musculoskeletal and connective tissue disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0021 affected42 at risk
EG003
Renal cyst
Renal and urinary disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Urinary bladder polyp
Renal and urinary disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected9 at risk
EG0020 affected42 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0021 affected42 at risk
EG003
Perineal cyst
Reproductive system and breast disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Sexual dysfunction
Reproductive system and breast disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Fatigue
General disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0021 affected42 at risk
EG003
Injection site pruritus
General disorders
MedDRA Version 25.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Oedema peripheral
General disorders
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Blood pressure increased
Investigations
MedDRA Version 25.0
Systematic Assessment
EG0001 affected19 at risk
EG0012 affected9 at risk
EG0020 affected42 at risk
EG003
Bone contusion
Injury, poisoning and procedural complications
MedDRA Version 25.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Clavicle fracture
Injury, poisoning and procedural complications
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0021 affected42 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0021 affected42 at risk
EG003
Patella fracture
Injury, poisoning and procedural complications
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Pelvic fracture
Injury, poisoning and procedural complications
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0021 affected42 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0021 affected42 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0021 affected42 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA Version 25.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA Version 25.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected9 at risk
EG0020 affected42 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Investigator understands that the information in the protocol is confidential and should not be disclosed, other than to those directly involved in the execution or the ethical review of the study, without prior written authorization from the Sponsor. It is, however, permissible to discuss information contained in the protocol with a participant in order to obtain consent once Institutional Review Board (IRB) approval is obtained.
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG00018
OG0019
OG00238
OG00319
OG00420
OG00513
OG00634
OG00739
Title
Denominators
Categories
H1N1
Title
Measurements
OG000296.2330(179.6681 to 488.4226)
OG001419.3985(206.7820 to 850.6303)
OG002222.1740(157.4823 to 313.4401)
OG003168.9548(103.8485 to 274.8785)
OG004174.3779(108.5108 to 280.2268)
OG005214.6073(119.1544 to 386.5261)
OG006165.0534(114.7138 to 237.4834)
OG007208.8559(148.7010 to 293.3456)
H3N2
Title
Measurements
OG000205.4037(109.7143 to 384.5505)
OG001217.8171(89.7300 to 528.7448)
OG002399.5021(259.4647 to 615.1201)
OG003
B/Yamagata lineage
Title
Measurements
OG00095.0432(52.2252 to 172.9667)
OG001117.6911(50.4649 to 274.4718)
OG002108.9616(72.1607 to 164.5304)
OG003
B/Victoria lineage
Title
Measurements
OG00091.4846(53.7284 to 155.7729)
OG00176.9675(36.2594 to 163.3783)
OG002121.7513(84.4092 to 175.6135)
OG003
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG00018
OG0019
OG00238
OG00319
OG00420
OG00513
OG00634
OG00739
Title
Denominators
Categories
H1N1
Title
Measurements
OG00038.9(17.30 to 64.25)
OG00155.6(21.20 to 86.30)
OG00236.8(21.81 to 54.01)
OG00342.1(20.25 to 66.50)
OG00425.0(8.66 to 49.10)
OG00530.8(9.09 to 61.43)
OG00629.4(15.10 to 47.48)
OG00738.5(23.36 to 55.38)
H3N2
Title
Measurements
OG00038.9(17.30 to 64.25)
OG00155.6(21.20 to 86.30)
OG00265.8(48.65 to 80.37)
OG003
B/Yamagata lineage
Title
Measurements
OG00033.3(13.34 to 59.01)
OG00122.2(2.81 to 60.01)
OG00231.6(17.50 to 48.65)
OG003
B/Victoria lineage
Title
Measurements
OG00044.4(21.53 to 69.24)
OG00133.3(7.49 to 70.07)
OG00226.3(13.40 to 43.10)
OG003
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG00018
OG0019
OG00238
OG00319
OG00420
OG00513
OG00634
OG00739
Title
Denominators
Categories
H1N1
Title
Measurements
OG000100(81.47 to 100.00)
OG001100(66.37 to 100.00)
OG002100(90.75 to 100.00)
OG00394.7(73.97 to 99.87)
OG00490.0(68.30 to 98.77)
OG005100(75.29 to 100.00)
OG006100(89.72 to 100.00)
OG007100(90.97 to 100.00)
H3N2
Title
Measurements
OG00088.9(65.29 to 98.62)
OG00188.9(51.75 to 99.72)
OG00297.4(86.19 to 99.93)
OG003
B/Yamagata lineage
Title
Measurements
OG00077.8(52.36 to 93.59)
OG00188.9(51.75 to 99.72)
OG00276.3(59.76 to 88.56)
OG003
B/Victoria lineage
Title
Measurements
OG00088.9(65.29 to 98.62)
OG00177.8(39.99 to 97.19)
OG00297.4(86.19 to 99.93)
OG003
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG00018
OG0019
OG00238
OG00319
OG00420
OG00513
OG00634
OG00739
Title
Denominators
Categories
H1N1
Title
Measurements
OG0004.0142(2.5134 to 6.4112)
OG0015.9788(3.0859 to 11.5835)
OG0023.2024(2.3211 to 4.4183)
OG0032.5570(1.6213 to 4.0326)
OG0042.5408(1.6304 to 3.9597)
OG0053.4414(1.9819 to 5.9757)
OG0062.3058(1.6405 to 3.2410)
OG0072.9661(2.1587 to 4.0755)
H3N2
Title
Measurements
OG0004.7572(2.6074 to 8.6794)
OG0015.1509(2.2007 to 12.0561)
OG0028.4563(5.5885 to 12.7956)
OG003
B/Yamagata lineage
Title
Measurements
OG0003.3872(2.1090 to 5.4401)
OG0012.7245(1.3900 to 5.3402)
OG0023.3189(2.3950 to 4.5993)
OG003
B/Victoria lineage
Title
Measurements
OG0002.7180(1.7465 to 4.2299)
OG0012.0988(1.1229 to 3.9228)
OG0023.0230(2.2264 to 4.1046)
OG003
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG00019
OG0019
OG00242
OG00319
OG00423
OG00513
OG00641
OG00743
Title
Denominators
Categories
Title
Measurements
OG0001
OG0010
OG0024
OG0033
OG0045
OG0051
OG0065
OG0074
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG0001
OG0010
OG0024
OG0033
OG0045
OG0051
OG0065
OG0074
Title
Denominators
Categories
Title
Measurements
Immediate solicited AE Grade 1
OG0001
OG0010
OG0024
OG0033
OG0044
OG0051
OG0064
OG0074
Immediate solicited AE Grade 2
OG0000
OG0010
OG0020
OG0030
OG004
Immediate solicited AE Grade 3
OG0000
OG0010
OG0020
OG0030
OG004
Immediate solicited AE Grade 4
OG0000
OG0010
OG0020
OG0030
OG004
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG0001
OG0010
OG0024
OG0033
OG0045
OG0051
OG0065
OG0074
Title
Denominators
Categories
Related immediate solicited AE
Title
Measurements
OG0001
OG0010
OG0024
OG0033
OG0045
OG0051
OG0065
OG0074
Related immediate unsolicited AE
Title
Measurements
OG0000
OG0010
OG0020
OG003
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG00019
OG0019
OG00242
OG00319
OG00423
OG00513
OG00641
OG00743
Title
Denominators
Categories
Title
Measurements
OG00012
OG0015
OG00237
OG00312
OG00414
OG0058
OG00626
OG00725
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG00012
OG0015
OG00237
OG00312
OG00414
OG0058
OG00626
OG00725
Title
Denominators
Categories
Title
Measurements
Solicited AE of Grade 1
OG0008
OG0013
OG00221
OG0038
OG0045
OG0057
OG00616
OG00716
Solicited AE of Grade 2
OG0003
OG0012
OG00213
OG0034
OG004
Solicited AE of Grade 3
OG0000
OG0010
OG0023
OG0030
OG004
Solicited AE of Grade 4
OG0001
OG0010
OG0020
OG0030
OG004
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG00019
OG0019
OG00242
OG00319
OG00423
OG00513
OG00641
OG00743
Title
Denominators
Categories
Title
Measurements
OG0006
OG0014
OG0026
OG0033
OG0041
OG0050
OG0068
OG0077
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG0006
OG0014
OG0026
OG0033
OG0041
OG0050
OG0068
OG0077
Title
Denominators
Categories
Title
Measurements
Unsolicited AE Grade 1
OG0003
OG0011
OG0021
OG0033
OG0040
OG0050
OG0064
OG0072
Unsolicited AE Grade 2
OG0001
OG0010
OG0024
OG0030
OG004
Unsolicited AE Grade 3
OG0002
OG0013
OG0021
OG0030
OG004
Unsolicited AE Grade 4
OG0000
OG0010
OG0020
OG0030
OG004
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG0006
OG0014
OG0026
OG0033
OG0041
OG0050
OG0068
OG0077
Title
Denominators
Categories
Title
Measurements
OG0003
OG0012
OG0022
OG0030
OG0040
OG0050
OG0060
OG0071
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG00019
OG0019
OG00242
OG00319
OG00423
OG00513
OG00641
OG00743
Title
Denominators
Categories
Title
Measurements
OG0001
OG0011
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG00019
OG0019
OG00242
OG00319
OG00423
OG00513
OG00641
OG00743
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG00019
OG0019
OG00242
OG00319
OG00423
OG00513
OG00641
OG00743
Title
Denominators
Categories
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG00019
OG0019
OG00242
OG00319
OG00423
OG00513
OG00641
OG00743
Title
Denominators
Categories
Title
Measurements
OG0002
OG0010
OG0023
OG0031
OG0041
OG0050
OG0067
OG0077
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG00019
OG0019
OG00242
OG00319
OG00423
OG00513
OG00641
OG00743
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG00019
OG0019
OG00242
OG00319
OG00423
OG00513
OG00641
OG00743
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG00019
OG0019
OG00242
OG00319
OG00423
OG00513
OG00641
OG00743
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
OG0022
OG0031
OG0041
OG0050
OG0060
OG0075
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG00019
OG0019
OG00242
OG00319
OG00423
OG00513
OG00641
OG00743
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG00019
OG0019
OG00242
OG00319
OG00423
OG00513
OG00641
OG00743
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG00019
OG0019
OG00242
OG00319
OG00423
OG00513
OG00641
OG00743
Title
Denominators
Categories
Title
Measurements
OG0003
OG0011
OG00214
OG0033
OG0042
OG0052
OG0066
OG00712
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG00019
OG0019
OG00242
OG00319
OG00423
OG00513
OG00641
OG00743
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0022
OG0030
OG0041
OG0050
OG0062
OG0070
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG00019
OG0019
OG00242
OG00319
OG00423
OG00513
OG00641
OG00743
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG00019
OG0019
OG00242
OG00319
OG00423
OG00513
OG00641
OG00743
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
OG0026
OG0031
OG0040
OG0050
OG0061
OG0072
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG00019
OG0019
OG00242
OG00319
OG00423
OG00513
OG00641
OG00743
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
OG0050
OG0060
OG0071
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG00019
OG0019
OG00242
OG00319
OG00423
OG00513
OG00641
OG00743
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG00019
OG0019
OG00242
OG00319
OG00423
OG00513
OG00641
OG00743
Title
Denominators
Categories
Title
Measurements
OG0003
OG0012
OG0028
OG0034
OG0040
OG0053
OG0065
OG0074
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG00019
OG0019
OG00242
OG00319
OG00423
OG00513
OG00641
OG00743
Title
Denominators
Categories
Title
Measurements
OG0001
OG0010
OG0021
OG0030
OG0040
OG0051
OG0060
OG0070
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG00019
OG0019
OG00242
OG00319
OG00423
OG00513
OG00641
OG00743
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
OG0050
OG0060
OG0071
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG00019
OG0019
OG00242
OG00319
OG00423
OG00513
OG00641
OG00743
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG00019
OG0019
OG00237
OG00318
OG00421
OG00513
OG00634
OG00733
Title
Denominators
Categories
H1N1: Day 182
ParticipantsOG00019
ParticipantsOG0019
ParticipantsOG00237
ParticipantsOG00318
ParticipantsOG00421
ParticipantsOG00513
ParticipantsOG00634
ParticipantsOG00733
Title
Measurements
OG000226.2152(133.2240 to 384.1147)
OG001332.5919(154.1053 to 717.8036)
OG002175.6786(120.2111 to 256.7397)
OG003
H1N1: Day 365
ParticipantsOG00018
ParticipantsOG0019
ParticipantsOG00231
ParticipantsOG00315
H3N2: Day 182
ParticipantsOG00019
ParticipantsOG0019
ParticipantsOG00237
ParticipantsOG00318
H3N2: Day 365
ParticipantsOG00018
ParticipantsOG0019
ParticipantsOG00231
ParticipantsOG00315
B/Yamagata lineage: Day 182
ParticipantsOG00019
ParticipantsOG0019
ParticipantsOG00237
ParticipantsOG00318
B/Yamagata lineage: Day 365
ParticipantsOG00018
ParticipantsOG0019
ParticipantsOG00231
ParticipantsOG00315
B/Victoria lineage: Day 182
ParticipantsOG00019
ParticipantsOG0019
ParticipantsOG00237
ParticipantsOG00318
B/Victoria lineage: Day 365
ParticipantsOG00018
ParticipantsOG0019
ParticipantsOG00231
ParticipantsOG00315
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG00019
OG0019
OG00237
OG00318
OG00421
OG00513
OG00634
OG00733
Title
Denominators
Categories
H1N1: Day 182
ParticipantsOG00019
ParticipantsOG0019
ParticipantsOG00237
ParticipantsOG00318
ParticipantsOG00421
ParticipantsOG00513
ParticipantsOG00634
ParticipantsOG00733
Title
Measurements
OG00036.8(16.29 to 61.64)
OG00155.6(21.20 to 86.30)
OG00216.2(6.19 to 32.01)
OG003
H1N1: Day 365
ParticipantsOG00018
ParticipantsOG0019
ParticipantsOG00231
ParticipantsOG00315
H3N2: Day 182
ParticipantsOG00019
ParticipantsOG0019
ParticipantsOG00237
ParticipantsOG00318
H3N2: Day 365
ParticipantsOG00018
ParticipantsOG0019
ParticipantsOG00231
ParticipantsOG00315
B/Yamagata lineage: Day 182
ParticipantsOG00019
ParticipantsOG0019
ParticipantsOG00237
ParticipantsOG00318
B/Yamagata lineage: Day 365
ParticipantsOG00018
ParticipantsOG0019
ParticipantsOG00231
ParticipantsOG00315
B/Victoria lineage: Day 182
ParticipantsOG00019
ParticipantsOG0019
ParticipantsOG00237
ParticipantsOG00318
B/Victoria lineage: Day 365
ParticipantsOG00018
ParticipantsOG0019
ParticipantsOG00231
ParticipantsOG00315
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG00019
OG0019
OG00237
OG00318
OG00421
OG00513
OG00634
OG00733
Title
Denominators
Categories
H1N1: Day 182
ParticipantsOG00019
ParticipantsOG0019
ParticipantsOG00237
ParticipantsOG00318
ParticipantsOG00421
ParticipantsOG00513
ParticipantsOG00634
ParticipantsOG00733
Title
Measurements
OG000100(82.35 to 100.00)
OG001100(66.37 to 100.00)
OG00294.6(81.81 to 99.34)
OG003
H1N1: Day 365
ParticipantsOG00018
ParticipantsOG0019
ParticipantsOG00231
ParticipantsOG00315
H3N2: Day 182
ParticipantsOG00019
ParticipantsOG0019
ParticipantsOG00237
ParticipantsOG00318
H3N2: Day 365
ParticipantsOG00018
ParticipantsOG0019
ParticipantsOG00231
ParticipantsOG00315
B/Yamagata lineage: Day 182
ParticipantsOG00019
ParticipantsOG0019
ParticipantsOG00237
ParticipantsOG00318
B/Yamagata lineage: Day 365
ParticipantsOG00018
ParticipantsOG0019
ParticipantsOG00231
ParticipantsOG00315
B/Victoria lineage: Day 182
ParticipantsOG00019
ParticipantsOG0019
ParticipantsOG00237
ParticipantsOG00318
B/Victoria lineage: Day 365
ParticipantsOG00018
ParticipantsOG0019
ParticipantsOG00231
ParticipantsOG00315
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG00019
OG0019
OG00237
OG00318
OG00421
OG00513
OG00634
OG00733
Title
Denominators
Categories
H1N1: Day 182/Day 0
ParticipantsOG00019
ParticipantsOG0019
ParticipantsOG00237
ParticipantsOG00318
ParticipantsOG00421
ParticipantsOG00513
ParticipantsOG00634
ParticipantsOG00733
Title
Measurements
OG0002.8586(1.7764 to 4.5999)
OG0014.6671(2.3416 to 9.3021)
OG0022.4366(1.7340 to 3.4239)
OG003
H1N1: Day 365/Day 0
ParticipantsOG00018
ParticipantsOG0019
ParticipantsOG00231
ParticipantsOG00315
H3N2: Day 182/Day 0
ParticipantsOG00019
ParticipantsOG0019
ParticipantsOG00237
ParticipantsOG00318
H3N2: Day 365/Day 0
ParticipantsOG00018
ParticipantsOG0019
ParticipantsOG00231
ParticipantsOG00315
B/Yamagata lineage: Day 182/Day 0
ParticipantsOG00019
ParticipantsOG0019
ParticipantsOG00237
ParticipantsOG00318
B/Yamagata lineage: Day 365/Day 0
ParticipantsOG00018
ParticipantsOG0019
ParticipantsOG00231
ParticipantsOG00315
B/Victoria lineage: Day 182/Day 0
ParticipantsOG00019
ParticipantsOG0019
ParticipantsOG00237
ParticipantsOG00318
B/Victoria lineage: Day 365/Day 0
ParticipantsOG00018
ParticipantsOG0019
ParticipantsOG00231
ParticipantsOG00315
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG00019
OG0019
OG00238
OG00319
OG00421
OG00513
OG00637
OG00739
Title
Denominators
Categories
H1N1: Day 0
ParticipantsOG00019
ParticipantsOG0019
ParticipantsOG00238
ParticipantsOG00319
ParticipantsOG00421
ParticipantsOG00513
ParticipantsOG00637
ParticipantsOG00739
Title
Measurements
OG00090.8941(46.5459 to 177.4963)
OG00160.8920(23.0277 to 161.0166)
OG00257.0448(35.5380 to 91.5672)
OG003
H1N1: Day 28
ParticipantsOG00018
ParticipantsOG0019
ParticipantsOG00238
ParticipantsOG00319
H3N2: Day 0
ParticipantsOG00019
ParticipantsOG0019
ParticipantsOG00238
ParticipantsOG00319
H3N2: Day 28
ParticipantsOG00018
ParticipantsOG0019
ParticipantsOG00238
ParticipantsOG00319
B/Victoria lineage: Day 0
ParticipantsOG00019
ParticipantsOG0019
ParticipantsOG00238
ParticipantsOG00319
B/Victoria lineage: Day 28
ParticipantsOG00018
ParticipantsOG0019
ParticipantsOG00238
ParticipantsOG00319
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG00018
OG0019
OG00238
OG00319
OG00420
OG00513
OG00634
OG00739
Title
Denominators
Categories
H1N1
Title
Measurements
OG00033.3(13.34 to 59.01)
OG00155.6(21.20 to 86.30)
OG00236.8(21.81 to 54.01)
OG00331.6(12.58 to 56.55)
OG00425.0(8.66 to 49.10)
OG00538.5(13.86 to 68.42)
OG00629.4(15.10 to 47.48)
OG00753.8(37.18 to 69.91)
H3N2
Title
Measurements
OG00016.7(3.58 to 41.42)
OG00133.3(7.49 to 70.07)
OG00218.4(7.74 to 34.33)
OG003
B/Victoria lineage
Title
Measurements
OG00011.1(1.38 to 34.71)
OG00111.1(0.28 to 48.25)
OG00213.2(4.41 to 28.09)
OG003
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG00019
OG0019
OG00238
OG00319
OG00420
OG00513
OG00634
OG00739
Title
Denominators
Categories
H1N1
ParticipantsOG00018
ParticipantsOG0019
ParticipantsOG00238
ParticipantsOG00319
ParticipantsOG00420
ParticipantsOG00513
ParticipantsOG00634
ParticipantsOG00739
Title
Measurements
OG000100(81.47 to 100.00)
OG001100(66.37 to 100.00)
OG00289.5(75.20 to 97.06)
OG003
H3N2
ParticipantsOG00018
ParticipantsOG0019
ParticipantsOG00238
ParticipantsOG00319
B/Victoria lineage
ParticipantsOG00018
ParticipantsOG0019
ParticipantsOG00238
ParticipantsOG00319
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG00018
OG0019
OG00238
OG00319
OG00420
OG00513
OG00634
OG00739
Title
Denominators
Categories
H1N1
Title
Measurements
OG0004.6104(2.6534 to 8.0105)
OG0017.7661(3.5725 to 16.8825)
OG0023.6764(2.5186 to 5.3663)
OG0032.4044(1.4056 to 4.1130)
OG0042.2511(1.3376 to 3.7885)
OG0054.1198(2.1579 to 7.8655)
OG0062.7513(1.8449 to 4.1028)
OG0075.0566(3.4783 to 7.3510)
H3N2
Title
Measurements
OG0002.8906(1.6272 to 5.1350)
OG0012.3315(1.0348 to 5.2531)
OG0022.6710(1.7985 to 3.9667)
OG003
B/Victoria lineage
Title
Measurements
OG0001.7604(1.1839 to 2.6177)
OG0011.8557(1.0562 to 3.2605)
OG0022.2441(1.7023 to 2.9582)
OG003
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG00019
OG0019
OG00238
OG00319
OG00421
OG00513
OG00636
OG00738
Title
Denominators
Categories
H1N1: Day 0
ParticipantsOG00019
ParticipantsOG0018
ParticipantsOG00238
ParticipantsOG00318
ParticipantsOG00421
ParticipantsOG00513
ParticipantsOG00636
ParticipantsOG00738
Title
Measurements
OG000195.2871(96.6328 to 394.6597)
OG001216.6401(73.2581 to 640.6514)
OG002127.4353(77.4879 to 209.5779)
OG003
H1N1: Day 28
ParticipantsOG00018
ParticipantsOG0019
ParticipantsOG00238
ParticipantsOG00319
H3N2: Day 0
ParticipantsOG00019
ParticipantsOG0017
ParticipantsOG00238
ParticipantsOG00318
H3N2: Day 28
ParticipantsOG00016
ParticipantsOG0019
ParticipantsOG00232
ParticipantsOG00316
B/Yamagata lineage: Day 0
ParticipantsOG00017
ParticipantsOG0018
ParticipantsOG00233
ParticipantsOG00315
B/Yamagata lineage: Day 28
ParticipantsOG00015
ParticipantsOG0019
ParticipantsOG00229
ParticipantsOG00315
B/Victoria lineage: Day 0
ParticipantsOG00019
ParticipantsOG0018
ParticipantsOG00238
ParticipantsOG00318
B/Victoria lineage: Day 28
ParticipantsOG00018
ParticipantsOG0019
ParticipantsOG00237
ParticipantsOG00318
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG00018
OG0018
OG00238
OG00318
OG00419
OG00513
OG00633
OG00737
Title
Denominators
Categories
H1N1
ParticipantsOG00018
ParticipantsOG0018
ParticipantsOG00238
ParticipantsOG00318
ParticipantsOG00419
ParticipantsOG00513
ParticipantsOG00633
ParticipantsOG00737
Title
Measurements
OG00038.9(17.30 to 64.25)
OG00150.0(15.70 to 84.30)
OG00255.3(38.30 to 71.38)
OG003
H3N2
ParticipantsOG00016
ParticipantsOG0017
ParticipantsOG00232
ParticipantsOG00315
B/Yamagata lineage
ParticipantsOG00015
ParticipantsOG0018
ParticipantsOG00229
ParticipantsOG00314
B/Victoria lineage
ParticipantsOG00018
ParticipantsOG0018
ParticipantsOG00237
ParticipantsOG00317
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG00018
OG0018
OG00238
OG00318
OG00419
OG00513
OG00633
OG00737
Title
Denominators
Categories
H1N1
ParticipantsOG00018
ParticipantsOG0018
ParticipantsOG00238
ParticipantsOG00318
ParticipantsOG00419
ParticipantsOG00513
ParticipantsOG00633
ParticipantsOG00737
Title
Measurements
OG0006.0914(3.2359 to 11.4669)
OG00112.7121(4.9188 to 32.8531)
OG0025.2592(3.4061 to 8.1206)
OG003
H3N2
ParticipantsOG00016
ParticipantsOG0017
ParticipantsOG00232
ParticipantsOG00315
B/Yamagata lineage
ParticipantsOG00015
ParticipantsOG0018
ParticipantsOG00229
ParticipantsOG00314
B/Victoria lineage
ParticipantsOG00018
ParticipantsOG0018
ParticipantsOG00237
ParticipantsOG00317
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG001
QVLP15+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG002
QVLP30+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
OG003
QVLP30+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG004
QVLP45+Full AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG005
QVLP45+Half AS03
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG006
QVLP30 Unadjuvanted
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
OG007
Fluzone HD Quad
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone HD Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).