Safety and Immunogenicity of Different Formulations of an... | NCT04782323 | Trialant
NCT04782323
Sponsor
Seqirus
Status
Completed
Last Update Posted
Oct 10, 2024Actual
Enrollment
839Actual
Phase
Phase 2
Conditions
Influenza
Interventions
aQII-1
aQII-3 Investigational
aQII-6 Investigational
aQII-7 Investigational
aQII-9 Investigational
aQII-10 Investigational
aQII-11 Investigational
Licensed QII Active Comparator
Countries
Australia
New Zealand
Philippines
South Africa
Protocol Section
Identification Module
NCT ID
NCT04782323
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
V201_01
Secondary IDs
Not provided
Brief Title
Safety and Immunogenicity of Different Formulations of an MF59-Adjuvanted Influenza Vaccine in Older Adults
Official Title
A Phase 2, Randomized, Observer-blind, Antigen and Adjuvant Dose Ranging Clinical Study to Evaluate Safety and Immunogenicity of Different Formulations of MF59 Adjuvanted Quadrivalent Subunit Inactivated Cell-derived Influenza Vaccine (aQIVc) in Older Adults ≥50 Years of Age
Acronym
Not provided
Organization
SeqirusINDUSTRY
Status Module
Record Verification Date
Oct 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
Not provided
Start Date
Apr 13, 2021Actual
Primary Completion Date
Sep 22, 2021Actual
Completion Date
Mar 3, 2022Actual
First Submitted Date
Mar 1, 2021
First Submission Date that Met QC Criteria
Mar 1, 2021
First Posted Date
Mar 4, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Sep 12, 2024
Results First Submitted that Met QC Criteria
Oct 8, 2024
Results First Posted Date
Oct 10, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Sep 16, 2022
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Oct 10, 2024Actual
Last Update Submitted Date
Oct 8, 2024
Last Update Posted Date
Oct 10, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
SeqirusINDUSTRY
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 Phase 2, randomized, observer-blind, antigen and adjuvant dose-ranging Clinical study is evaluating different formulations of MF59-Adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine. Approximately 800 subjects are to be randomized into 1 of 8 possible treatment groups. Immunogenicity and safety will be assessed in the overall study population (adults ≥50 years and above) and in the age subgroups ≥50-64 years and ≥65 years. Data from this study will be used to select the optimal dose to be tested in the pivotal Phase 3 immunogenicity and safety study in older adults.
Disclosure Statement: This is a parallel-group dose-ranging study with 8 arms that is participant, investigator and observer-blinded.
Detailed Description
Not provided
Conditions Module
Conditions
Influenza
Keywords
Not provided
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 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
839Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Group A aQII-1 Investigational
Experimental
Drug: aQII-1
Group B aQII-3 Investigational
Experimental
Drug: aQII-3 Investigational
Group C aQII-6 Investigational
Experimental
Drug: aQII-6 Investigational
Group D aQII-7 Investigational
Experimental
Other: aQII-7 Investigational
Group E aQII-9 Investigational
Experimental
Drug: aQII-9 Investigational
Group F aQII-10 Investigational
Experimental
Drug: aQII-10 Investigational
Group G aQII-11 Investigational
Experimental
Drug: aQII-11 Investigational
Interventions
Name
Type
Description
Arm Group Labels
Other Names
aQII-1
Drug
Biological/Vaccine: Investigational aQII-1 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay
[28 days post-vaccination]
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and for A/H3N2 Strain Using MN Assay
28 days post-vaccination
Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and A/H3N2 Strain Using MN Assay
Seroconversion is defined as ≥4-fold increase in titer postvaccination in those with pre-vaccination titer above or equal to the Lower Limit of Quantitation (LLOQ) (≥1:10), or a post-vaccination titer ≥1:40 for subjects with baseline titer below the LLOQ (1:10) for HI titers
28 days post-vaccination
Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay)
28 days post-vaccination
Safety Endpoint: Percentage of Subjects With Solicited Local or Systemic Reactions
Percentage of subjects with at least one solicited AE Day 1 through Day 7 after study vaccination
7 days post-vaccination
Safety Endpoint: The Percentage of Subjects With Any Unsolicited Adverse Events
The percentage of subjects with at least one unsolicited AE from Day 1 to Day 29.
Related AEs = considered at least possibly related to study vaccination by the investigator
28 days post-vaccination
Secondary Outcomes
Measure
Description
Time Frame
Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period
180 days post-vaccination
Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
INCLUSION CRITERIA:
In order to participate in this study, all subjects must meet ALL of the inclusion criteria described.
Individuals ≥50 years of age on the day of informed consent.
Individuals who have voluntarily given written consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
Individuals who can comply with study procedures including follow-up .
Males, females of non-childbearing potential or females of childbearing potential who are using an effective birth control method, at least 30 days prior to informed consent, which they intend to use for at least 2 months after the study vaccination.
EXCLUSION CRITERIA:
In order to participate in this study, all subjects must not meet ANY of the exclusion criteria described below:
Females of childbearing potential who are pregnant, lactating, or who have not adhered to a specified set of contraceptive methods from at least 30 days prior to informed consent and who do not plan to do so for at least 2 months after the study vaccination.
Progressive, unstable or uncontrolled clinical conditions.
Hypersensitivity, including allergy, to any component of vaccines whose use is foreseen in this study.
History of any medical condition considered an adverse event of special interest (AESI).
Clinical conditions representing a contraindication to intramuscular administration of vaccines or blood draw.
Abnormal function of the immune system resulting from:
Clinical conditions.
Systemic administration of corticosteroids (PO/IV/IM) at a dose of ≥20 mg/day of prednisone or equivalent for more than 14 consecutive days within 90 days prior to informed consent.
Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.
Receipt of immunoglobulins or any blood products within 180 days prior to informed consent.
Receipt of an investigational or non-registered medicinal product within 30 days prior to vaccination.
Individuals who received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this study or who are planning to receive any vaccine within 28 days from the study vaccines.
Study personnel or immediate family or household member of study personnel.
Receipt of any influenza vaccine within 6 months prior to vaccination in this study, or plan to receive an influenza vaccine during the study period.
Acute (severe) febrile illness.
Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
50 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Therapeutic Area Head
Seqirus
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
03607 - PCRN_Paratus Clinical Research
Bruce
Australian Capital Territory
2617
Australia
03605 - PCRN_Paratus Clinical Research (Central Coast)
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
SEQIRUS supports the release of anonymized subject-level and study-level data in compliance with regulatory requirements, including Clinical Documents which are part of the CTD modules submitted to regulatory agencies for public release.
Summary results disclosure is either in document form (e.g., ICH E3 Clinical Study Report synopsis) or structured data form (such as summary results in ClinicalTrials.gov (United States) or eudract.ema.europa.eu (EU Clinical Trial Registry [EU CTR])
Types
Study Protocol
Statistical Analysis Plan (SAP)
Time Frame
Time Frame:
SEQIRUS discloses results from clinical studies within 12 months of last patient last visit (LPLV) unless otherwise mandated by local laws or regulations.
Access Criteria
SEQIRUS will consider requests from qualified scientific and medical researchers to disclose protocols, anonymized subject-level data and study-level data when there is medical, scientific and/or public health interest to ensure the safe use of a Seqirus product licensed on or after 1 January 2014 in the United States (US) and/or the European Union (EU). This applies to Seqirus-sponsored interventional studies initiated after 27 September 2007 and ongoing as of 26 December 2007, that have been included as part of a US or EU submission package which received approval in US and EU on or after 1 January 2014 and have been accepted for publication
Licensed QII Active Comparator: Biological/Vaccine: Licensed QII Active Comparator Licensed Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jan 22, 2021
Jun 17, 2024
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
This is a parallel-group dose-ranging study with 8 arms that is participant, investigator and observer-blinded
Who Masked
ParticipantCare ProviderInvestigator
Group H Licensed QII Active Comparator
Active Comparator
Drug: Licensed QII Active Comparator
Group A aQII-1 Investigational
aQII-3 Investigational
Drug
Biological/Vaccine: Investigational aQII-3 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Group B aQII-3 Investigational
aQII-6 Investigational
Drug
Biological/Vaccine: Investigational aQII-6 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Group C aQII-6 Investigational
aQII-7 Investigational
Other
Biological/Vaccine: Investigational aQII-7 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Group D aQII-7 Investigational
aQII-9 Investigational
Drug
Biological/Vaccine: Investigational aQII-9 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Group E aQII-9 Investigational
aQII-10 Investigational
Drug
Biological/Vaccine: Investigational aQII-10 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Group F aQII-10 Investigational
aQII-11 Investigational
Drug
Biological/Vaccine: Investigational aQII-11 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Group G aQII-11 Investigational
Licensed QII Active Comparator
Drug
Biological/Vaccine: Licensed QII Licensed Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Group H Licensed QII Active Comparator
Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs)
28 days post-vaccination
28 days post-vaccination
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization Assay
28 days post-vaccination
Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay
Seroconversion is defined as ≥4-fold increase in titer postvaccination in those with pre-vaccination titer above or equal to the Lower Limit of Quantitation (LLOQ) (≥1:10), or a post-vaccination titer ≥1:40 for subjects with baseline titer below the LLOQ (1:10) for HI titers
28 days post-vaccination
Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay
180 days post-vaccination
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay
180 days post-vaccination
Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay)
180 days post-vaccination
Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay
180 days post-vaccination
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay
aQII-1: Biological/Vaccine: Investigational aQII-1 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
FG002
Group E aQII-9 Investigational
aQII-9 Investigational: Biological/Vaccine: Investigational aQII-9 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
FG003
Group C aQII-6 Investigational
aQII-6 Investigational: Biological/Vaccine: Investigational aQII-6 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
FG004
Group F aQII-10 Investigational
aQII-10 Investigational: Biological/Vaccine: Investigational aQII-10 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
FG005
Group B aQII-3 Investigational
aQII-3 Investigational: Biological/Vaccine: Investigational aQII-3 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
FG006
Group D aQII-7 Investigational
aQII-7 Investigational: Biological/Vaccine: Investigational aQII-7 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
FG007
Group G aQII-11 Investigational
aQII-11 Investigational: Biological/Vaccine: Investigational aQII-11 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
FG00098 subjects
FG001107 subjects
FG002107 subjects
FG003103 subjects
FG004106 subjects
FG005108 subjects
FG006101 subjects
FG007109 subjects
COMPLETED
FG00096 subjects
FG001106 subjects
FG002105 subjects
FG003103 subjects
FG004105 subjects
FG005105 subjects
FG00699 subjects
FG007106 subjects
NOT COMPLETED
FG0002 subjects
FG0011 subjects
FG0022 subjects
FG0030 subjects
FG0041 subjects
FG0053 subjects
FG0062 subjects
FG0073 subjects
Type
Comment
Reasons
Death
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0051 subjects
FG0061 subjects
FG0070 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
randomization in error
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Group H Licensed QII Active Comparator
Licensed QII Active Comparator: Biological/Vaccine: Licensed QII Active Comparator Licensed Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
BG001
Group A aQII-1 Investigational
aQII-1: Biological/Vaccine: Investigational aQII-1 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
BG002
Group E aQII-9 Investigational
aQII-9 Investigational: Biological/Vaccine: Investigational aQII-9 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
BG003
Group C aQII-6 Investigational
aQII-6 Investigational: Biological/Vaccine: Investigational aQII-6 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
BG004
Group F aQII-10 Investigational
aQII-10 Investigational: Biological/Vaccine: Investigational aQII-10 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
BG005
Group B aQII-3 Investigational
aQII-3 Investigational: Biological/Vaccine: Investigational aQII-3 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
BG006
Group D aQII-7 Investigational
aQII-7 Investigational: Biological/Vaccine: Investigational aQII-7 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
BG007
Group G aQII-11 Investigational
aQII-11 Investigational: Biological/Vaccine: Investigational aQII-11 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00098
BG001107
BG002107
BG003103
BG004106
BG005108
BG006101
BG007109
BG008839
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00063.4± 7.68
BG00163.6± 8.91
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00069
BG00162
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
white
Title
Measurements
BG00056
BG00166
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
New Zealand
Title
Measurements
BG00029
BG00132
BG002
vaccinated within 3 previous influenza season
Count of Participants
Participants
Title
Denominators
Categories
Yes
Title
Measurements
BG00060
BG00166
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
Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay and for A/H3N2 Strain Using Microneutralization Assay
Per Protocol Set (PPS) Immunogenicity: All subjects in the FAS Immunogenicity who
Correctly received the vaccine (ie, received the vaccine to which the subject was randomized within the defined window).
Had no CSR-reportable PD leading to exclusion (ie, impacting the results) as defined prior to unblinding.
Had immunogenicity assessments within the window of -7/+21 days around the Day 29 visit, and Day 1 sample taken.
Were not excluded due to other reason defined prior to unblinding.
Posted
Geometric Mean
95% Confidence Interval
titer
[28 days post-vaccination]
ID
Title
Description
OG000
Group H Licensed QII Active Comparator
Licensed QII Active Comparator: Biological/Vaccine: Licensed QII Active Comparator Licensed Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG001
Group A aQII-1 Investigational
aQII-1: Biological/Vaccine: Investigational aQII-1 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG002
Group E aQII-9 Investigational
aQII-9 Investigational: Biological/Vaccine: Investigational aQII-9 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG003
Group C aQII-6 Investigational
aQII-6 Investigational: Biological/Vaccine: Investigational aQII-6 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG004
Group F aQII-10 Investigational
aQII-10 Investigational: Biological/Vaccine: Investigational aQII-10 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG005
Group B aQII-3 Investigational
aQII-3 Investigational: Biological/Vaccine: Investigational aQII-3 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG006
Group D aQII-7 Investigational
aQII-7 Investigational: Biological/Vaccine: Investigational aQII-7 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG007
Group G aQII-11 Investigational
aQII-11 Investigational: Biological/Vaccine: Investigational aQII-11 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Units
Counts
Participants
OG00095
OG001105
OG002106
OG003
Title
Denominators
Categories
A/H1N1 Day 1 HI GMT
Title
Measurements
OG00042.31(34.3 to 52.2)
OG00140.39(33.1 to 49.3)
OG00248.29(39.6 to 58.9)
Primary
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HI Assay and for A/H3N2 Strain Using MN Assay
The analysis population is PPS Immunogenicity.
Posted
Geometric Mean
95% Confidence Interval
Ratio
28 days post-vaccination
ID
Title
Description
OG000
Group A aQII-1 Investigational
aQII-1: Biological/Vaccine: Investigational aQII-1 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG001
Group E aQII-9 Investigational
aQII-9 Investigational: Biological/Vaccine: Investigational aQII-9 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG002
Group C aQII-6 Investigational
aQII-6 Investigational: Biological/Vaccine: Investigational aQII-6 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Primary
Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by HI Assay and A/H3N2 Strain Using MN Assay
Seroconversion is defined as ≥4-fold increase in titer postvaccination in those with pre-vaccination titer above or equal to the Lower Limit of Quantitation (LLOQ) (≥1:10), or a post-vaccination titer ≥1:40 for subjects with baseline titer below the LLOQ (1:10) for HI titers
The analysis population is PPS Immunogenicity.
Posted
Number
95% Confidence Interval
percentage of subjects
28 days post-vaccination
ID
Title
Description
OG000
Group H Licensed QII Active Comparator
Licensed QII Active Comparator: Biological/Vaccine: Licensed QII Active Comparator Licensed Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG001
Group A aQII-1 Investigational
aQII-1: Biological/Vaccine: Investigational aQII-1 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG002
Primary
Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay)
The analysis population is PPS Immunogenicity.
Posted
Number
95% Confidence Interval
percentage of subjects
28 days post-vaccination
ID
Title
Description
OG000
Group H Licensed QII Active Comparator
Licensed QII Active Comparator: Biological/Vaccine: Licensed QII Active Comparator Licensed Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG001
Group A aQII-1 Investigational
aQII-1: Biological/Vaccine: Investigational aQII-1 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG002
Group E aQII-9 Investigational
aQII-9 Investigational: Biological/Vaccine: Investigational aQII-9 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Primary
Safety Endpoint: Percentage of Subjects With Solicited Local or Systemic Reactions
Percentage of subjects with at least one solicited AE Day 1 through Day 7 after study vaccination
Solicited Safety Set, defined as all subjects in the Exposed Set with any solicited AE data.
Posted
Count of Participants
Participants
7 days post-vaccination
ID
Title
Description
OG000
Group H Licensed QII Active Comparator
Licensed QII Active Comparator: Biological/Vaccine: Licensed QII Active Comparator Licensed Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG001
Group A aQII-1 Investigational
aQII-1: Biological/Vaccine: Investigational aQII-1 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG002
Group E aQII-9 Investigational
aQII-9 Investigational: Biological/Vaccine: Investigational aQII-9 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Primary
Safety Endpoint: The Percentage of Subjects With Any Unsolicited Adverse Events
The percentage of subjects with at least one unsolicited AE from Day 1 to Day 29.
Related AEs = considered at least possibly related to study vaccination by the investigator
Unsolicited Safety Set, defined as all subjects in the Exposed Set with any unsolicited AE data
Posted
Count of Participants
Participants
28 days post-vaccination
ID
Title
Description
OG000
Group H Licensed QII Active Comparator
Licensed QII Active Comparator: Biological/Vaccine: Licensed QII Active Comparator Licensed Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG001
Group A aQII-1 Investigational
aQII-1: Biological/Vaccine: Investigational aQII-1 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG002
Group E aQII-9 Investigational
Primary
Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs)
Unsolicited Safety Set, defined as all subjects in the Exposed Set with any unsolicited AE data
Posted
Count of Participants
Participants
28 days post-vaccination
ID
Title
Description
OG000
Group H Licensed QII Active Comparator
Licensed QII Active Comparator: Biological/Vaccine: Licensed QII Active Comparator Licensed Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG001
Group A aQII-1 Investigational
aQII-1: Biological/Vaccine: Investigational aQII-1 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG002
Group E aQII-9 Investigational
aQII-9 Investigational: Biological/Vaccine: Investigational aQII-9 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Secondary
Safety Endpoint: The Percentage of Subjects With Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and Medically Attended Adverse Events (MAAEs) During the Entire Study Period
Unsolicited Safety Set, defined as all subjects in the Exposed Set with any unsolicited AE data
Posted
Count of Participants
Participants
180 days post-vaccination
ID
Title
Description
OG000
Group H Licensed QII Active Comparator
Licensed QII Active Comparator: Biological/Vaccine: Licensed QII Active Comparator Licensed Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG001
Group A aQII-1 Investigational
aQII-1: Biological/Vaccine: Investigational aQII-1 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG002
Group E aQII-9 Investigational
aQII-9 Investigational: Biological/Vaccine: Investigational aQII-9 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Secondary
Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization (MN) Assay
The analysis population is PPS Immunogenicity.
Posted
Geometric Mean
95% Confidence Interval
titer
28 days post-vaccination
ID
Title
Description
OG000
Group H Licensed QII Active Comparator
Licensed QII Active Comparator: Biological/Vaccine: Licensed QII Active Comparator Licensed Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG001
Group A aQII-1 Investigational
aQII-1: Biological/Vaccine: Investigational aQII-1 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG002
Group E aQII-9 Investigational
aQII-9 Investigational: Biological/Vaccine: Investigational aQII-9 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Secondary
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Microneutralization Assay
The analysis population is PPS Immunogenicity.
Posted
Geometric Mean
95% Confidence Interval
Ratio
28 days post-vaccination
ID
Title
Description
OG000
Group A aQII-1 Investigational
aQII-1: Biological/Vaccine: Investigational aQII-1 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG001
Group E aQII-9 Investigational
aQII-9 Investigational: Biological/Vaccine: Investigational aQII-9 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG002
Group C aQII-6 Investigational
aQII-6 Investigational: Biological/Vaccine: Investigational aQII-6 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Secondary
Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion for the A/H1N1, B/Victoria and B/Yamagata Strains by MN Assay
Seroconversion is defined as ≥4-fold increase in titer postvaccination in those with pre-vaccination titer above or equal to the Lower Limit of Quantitation (LLOQ) (≥1:10), or a post-vaccination titer ≥1:40 for subjects with baseline titer below the LLOQ (1:10) for HI titers
The analysis population is PPS Immunogenicity.
Posted
Number
95% Confidence Interval
percentage of subjects
28 days post-vaccination
ID
Title
Description
OG000
Group H Licensed QII Active Comparator
Licensed QII Active Comparator: Biological/Vaccine: Licensed QII Active Comparator Licensed Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG001
Group A aQII-1 Investigational
aQII-1: Biological/Vaccine: Investigational aQII-1 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG002
Group E aQII-9 Investigational
Secondary
Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay
The analysis population is PPS Immunogenicity.
Posted
Geometric Mean
95% Confidence Interval
titer
180 days post-vaccination
ID
Title
Description
OG000
Group H Licensed QII Active Comparator
Licensed QII Active Comparator: Biological/Vaccine: Licensed QII Active Comparator Licensed Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG001
Group A aQII-1 Investigational
aQII-1: Biological/Vaccine: Investigational aQII-1 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG002
Group E aQII-9 Investigational
aQII-9 Investigational: Biological/Vaccine: Investigational aQII-9 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Secondary
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HI) Assay
The analysis population is PPS Immunogenicity.
Posted
Geometric Mean
95% Confidence Interval
Ratio
180 days post-vaccination
ID
Title
Description
OG000
Group A aQII-1 Investigational
aQII-1: Biological/Vaccine: Investigational aQII-1 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG001
Group E aQII-9 Investigational
aQII-9 Investigational: Biological/Vaccine: Investigational aQII-9 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG002
Group C aQII-6 Investigational
aQII-6 Investigational: Biological/Vaccine: Investigational aQII-6 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Secondary
Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 for A/H1N1, B/Yamagata and B/Victoria Strains (HI Assay)
The analysis population is PPS Immunogenicity.
Posted
Number
95% Confidence Interval
percentage
180 days post-vaccination
ID
Title
Description
OG000
Group H Licensed QII Active Comparator
Licensed QII Active Comparator: Biological/Vaccine: Licensed QII Active Comparator Licensed Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG001
Group A aQII-1 Investigational
aQII-1: Biological/Vaccine: Investigational aQII-1 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG002
Group E aQII-9 Investigational
aQII-9 Investigational: Biological/Vaccine: Investigational aQII-9 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Secondary
Immunogenicity Endpoint: Geometric Mean Titer (GMT) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay
The analysis population is PPS Immunogenicity.
Posted
Geometric Mean
95% Confidence Interval
titer
180 days post-vaccination
ID
Title
Description
OG000
Group H Licensed QII Active Comparator
Licensed QII Active Comparator: Biological/Vaccine: Licensed QII Active Comparator Licensed Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG001
Group A aQII-1 Investigational
aQII-1: Biological/Vaccine: Investigational aQII-1 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG002
Group E aQII-9 Investigational
aQII-9 Investigational: Biological/Vaccine: Investigational aQII-9 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Secondary
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (GMR is GMT Ratio of aQII Formulation/Licensed QII) for the A/H1N1, A/H3N2, B/Victoria and B/Yamagata Vaccine Strains by MN Assay
The analysis population is PPS Immunogenicity.
Posted
Geometric Mean
95% Confidence Interval
Ratio
180 days post-vaccination
ID
Title
Description
OG000
Group A aQII-1 Investigational
aQII-1: Biological/Vaccine: Investigational aQII-1 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG001
Group E aQII-9 Investigational
aQII-9 Investigational: Biological/Vaccine: Investigational aQII-9 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG002
Group C aQII-6 Investigational
aQII-6 Investigational: Biological/Vaccine: Investigational aQII-6 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Time Frame
Time frame for all-cause mortality: 6 months SAEs: Day 1 to Day 181, Nonserious unsolicited AEs: Day 1 to Day 29, Solicited AEs: Day 1 to Day 7 after vaccination
Description
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
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
Group H Licensed QII Active Comparator
Licensed QII Active Comparator: Biological/Vaccine: Licensed QII Active Comparator Licensed Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
1
97
8
97
55
97
EG001
Group A aQII-1 Investigational
aQII-1: Biological/Vaccine: Investigational aQII-1 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
0
107
1
107
74
107
EG002
Group E aQII-9 Investigational
aQII-9 Investigational: Biological/Vaccine: Investigational aQII-9 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
0
108
1
108
80
108
EG003
Group C aQII-6 Investigational
aQII-6 Investigational: Biological/Vaccine: Investigational aQII-6 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
0
103
3
103
79
103
EG004
Group F aQII-10 Investigational
aQII-10 Investigational: Biological/Vaccine: Investigational aQII-10 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
1
106
5
106
91
106
EG005
Group B aQII-3 Investigational
aQII-3 Investigational: Biological/Vaccine: Investigational aQII-3 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
1
107
3
107
81
107
EG006
Group D aQII-7 Investigational
aQII-7 Investigational: Biological/Vaccine: Investigational aQII-7 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
1
101
2
101
72
101
EG007
Group G aQII-11 Investigational
aQII-11 Investigational: Biological/Vaccine: Investigational aQII-11 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
0
109
2
109
89
109
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
retinal detachment
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected97 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected108 at risk
EG0030 events0 affected103 at risk
EG0041 events1 affected106 at risk
EG0050 events0 affected107 at risk
EG0060 events0 affected101 at risk
EG0070 events0 affected109 at risk
intestinal obstruction
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected97 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected108 at risk
EG003
death
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected97 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected108 at risk
EG003
biliary colic
Hepatobiliary disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected97 at risk
EG0010 events0 affected107 at risk
EG0021 events1 affected108 at risk
EG003
cholecystitis acute
Hepatobiliary disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected97 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected108 at risk
EG003
drug hypersensitivity
Immune system disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected97 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected108 at risk
EG003
pneumonia
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected97 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected108 at risk
EG003
appendicitis
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected97 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected108 at risk
EG003
cellulitis
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected97 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected108 at risk
EG003
diverticulitis
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected97 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected108 at risk
EG003
pyelonephritis
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected97 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected108 at risk
EG003
sepsis
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected97 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected108 at risk
EG003
ankle fracture
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected97 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected108 at risk
EG003
bone contusion
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected97 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected108 at risk
EG003
face injury
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected97 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected108 at risk
EG003
skin laceration
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected97 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected108 at risk
EG003
hypoglycaemia
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected97 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected108 at risk
EG003
arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected97 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected108 at risk
EG003
polymyalgia rheumatica
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected97 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected108 at risk
EG003
adenocarcinoma of colon
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected97 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected108 at risk
EG003
breast cancer female
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected97 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected108 at risk
EG003
colorectal adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected97 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected108 at risk
EG003
oesophageal adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected97 at risk
EG0011 events1 affected107 at risk
EG0020 events0 affected108 at risk
EG003
squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
aQII-10 Investigational: Biological/Vaccine: Investigational aQII-10 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG004
Group B aQII-3 Investigational
aQII-3 Investigational: Biological/Vaccine: Investigational aQII-3 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG005
Group D aQII-7 Investigational
aQII-7 Investigational: Biological/Vaccine: Investigational aQII-7 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG006
Group G aQII-11 Investigational
aQII-11 Investigational: Biological/Vaccine: Investigational aQII-11 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Units
Counts
Participants
OG000105
OG001106
OG00299
OG003102
OG004104
OG00595
OG006104
Title
Denominators
Categories
A/H1N1 HI GMR (aQII/QII)
Title
Measurements
OG0000.77(0.56 to 1.06)
OG0010.88(0.64 to 1.20)
OG0020.99(0.72 to 1.36)
OG0030.98(0.71 to 1.35)
OG0041.07(0.78 to 1.46)
OG0051.19(0.86 to 1.64)
OG0060.97(0.70 to 1.33)
B/Yamagata HI GMR (aQII/QII)
Title
Measurements
OG0000.99(0.78 to 1.27)
OG0011.25(0.98 to 1.59)
OG0021.31(1.02 to 1.67)
OG003
B/Victoria HI GMR (aQII/QII)
Title
Measurements
OG0001.01(0.82 to 1.25)
OG0010.95(0.77 to 1.18)
OG0020.98(0.79 to 1.21)
OG003
A/H3N2 MN GMR (aQII/QII)
Title
Measurements
OG0000.97(0.77 to 1.22)
OG0011.22(0.97 to 1.53)
OG0021.26(1.00 to 1.59)
OG003
Group E aQII-9 Investigational
aQII-9 Investigational: Biological/Vaccine: Investigational aQII-9 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG003
Group C aQII-6 Investigational
aQII-6 Investigational: Biological/Vaccine: Investigational aQII-6 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG004
Group F aQII-10 Investigational
aQII-10 Investigational: Biological/Vaccine: Investigational aQII-10 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG005
Group B aQII-3 Investigational
aQII-3 Investigational: Biological/Vaccine: Investigational aQII-3 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG006
Group D aQII-7 Investigational
aQII-7 Investigational: Biological/Vaccine: Investigational aQII-7 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG007
Group G aQII-11 Investigational
aQII-11 Investigational: Biological/Vaccine: Investigational aQII-11 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Units
Counts
Participants
OG00095
OG001105
OG002106
OG00399
OG004102
OG005104
OG00695
OG007104
Title
Denominators
Categories
A/H1N1 HI seroconversion Day 29
Title
Measurements
OG00055.8(45.2 to 66.0)
OG00153.3(43.3 to 63.1)
OG00251.9(42.0 to 61.7)
OG00354.5(44.2 to 64.6)
OG00457.8(47.7 to 67.6)
OG00558.7(48.6 to 68.2)
OG00660.0(49.4 to 69.9)
OG00757.7(47.6 to 67.3)
B/Yamagata HI seroconversion Day 29
Title
Measurements
OG00035.8(26.2 to 46.3)
OG00135.2(26.2 to 45.2)
OG00242.5(32.9 to 52.4)
OG003
B/Victoria HI seroconversion Day 29
Title
Measurements
OG00032.6(23.4 to 43.0)
OG00125.7(17.7 to 35.2)
OG00222.6(15.1 to 31.8)
OG003
A/H3N2 MN seroconversion Day 29
Title
Measurements
OG00053.7(43.2 to 64.0)
OG00154.3(44.3 to 64.0)
OG00267.0(57.2 to 75.8)
OG003
OG003
Group C aQII-6 Investigational
aQII-6 Investigational: Biological/Vaccine: Investigational aQII-6 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG004
Group F aQII-10 Investigational
aQII-10 Investigational: Biological/Vaccine: Investigational aQII-10 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG005
Group B aQII-3 Investigational
aQII-3 Investigational: Biological/Vaccine: Investigational aQII-3 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG006
Group D aQII-7 Investigational
aQII-7 Investigational: Biological/Vaccine: Investigational aQII-7 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG007
Group G aQII-11 Investigational
aQII-11 Investigational: Biological/Vaccine: Investigational aQII-11 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Units
Counts
Participants
OG00095
OG001105
OG002106
OG00399
OG004102
OG005104
OG00695
OG007104
Title
Denominators
Categories
A/H1N1 Day 1
Title
Measurements
OG00066.3(55.9 to 75.7)
OG00160.0(50.0 to 69.4)
OG00267.9(58.2 to 76.7)
OG00371.7(61.8 to 80.3)
OG00468.6(58.7 to 77.5)
OG00566.3(56.4 to 75.3)
OG00666.3(55.9 to 75.7)
OG00751.0(41.0 to 60.9)
A/H1N1 Day 29
Title
Measurements
OG00095.8(89.6 to 98.8)
OG00194.3(88.0 to 97.9)
OG00296.2(90.6 to 99.0)
OG003
B/Yamagata day 1
Title
Measurements
OG00022.1(14.2 to 31.8)
OG00129.5(21.0 to 39.2)
OG00234.9(25.9 to 44.8)
OG003
B/Yamagata day 29
Title
Measurements
OG00074.7(64.8 to 83.1)
OG00168.6(58.8 to 77.3)
OG00278.3(69.2 to 85.7)
OG003
B/Victoria Day 1
Title
Measurements
OG00072.6(62.5 to 81.3)
OG00178.1(69.0 to 85.6)
OG00281.1(72.4 to 88.1)
OG003
B/Victoria Day 29
Title
Measurements
OG00094.7(88.1 to 98.3)
OG00192.4(85.5 to 96.7)
OG00295.3(89.3 to 98.5)
OG003
OG003
Group C aQII-6 Investigational
aQII-6 Investigational: Biological/Vaccine: Investigational aQII-6 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG004
Group F aQII-10 Investigational
aQII-10 Investigational: Biological/Vaccine: Investigational aQII-10 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG005
Group B aQII-3 Investigational
aQII-3 Investigational: Biological/Vaccine: Investigational aQII-3 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG006
Group D aQII-7 Investigational
aQII-7 Investigational: Biological/Vaccine: Investigational aQII-7 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG007
Group G aQII-11 Investigational
aQII-11 Investigational: Biological/Vaccine: Investigational aQII-11 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Units
Counts
Participants
OG00096
OG001107
OG002107
OG003103
OG004105
OG005105
OG006101
OG007108
Title
Denominators
Categories
solicited AEs
Title
Measurements
OG00044
OG00169
OG00271
OG00376
OG00485
OG00573
OG00660
OG00782
Solicited local AEs
Title
Measurements
OG00029
OG00155
OG00263
OG003
Solicited systemic AEs
Title
Measurements
OG00034
OG00148
OG00249
OG003
aQII-9 Investigational: Biological/Vaccine: Investigational aQII-9 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG003
Group C aQII-6 Investigational
aQII-6 Investigational: Biological/Vaccine: Investigational aQII-6 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG004
Group F aQII-10 Investigational
aQII-10 Investigational: Biological/Vaccine: Investigational aQII-10 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG005
Group B aQII-3 Investigational
aQII-3 Investigational: Biological/Vaccine: Investigational aQII-3 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG006
Group D aQII-7 Investigational
aQII-7 Investigational: Biological/Vaccine: Investigational aQII-7 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG007
Group G aQII-11 Investigational
aQII-11 Investigational: Biological/Vaccine: Investigational aQII-11 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Units
Counts
Participants
OG00097
OG001107
OG002108
OG003103
OG004106
OG005107
OG006101
OG007109
Title
Denominators
Categories
Any Unsolicited AE
Title
Measurements
OG00029
OG00127
OG00226
OG00330
OG00432
OG00526
OG00630
OG00730
Any Related Unsolicited AE
Title
Measurements
OG0009
OG0017
OG00211
OG003
OG003
Group C aQII-6 Investigational
aQII-6 Investigational: Biological/Vaccine: Investigational aQII-6 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG004
Group F aQII-10 Investigational
aQII-10 Investigational: Biological/Vaccine: Investigational aQII-10 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG005
Group B aQII-3 Investigational
aQII-3 Investigational: Biological/Vaccine: Investigational aQII-3 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG006
Group D aQII-7 Investigational
aQII-7 Investigational: Biological/Vaccine: Investigational aQII-7 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG007
Group G aQII-11 Investigational
aQII-11 Investigational: Biological/Vaccine: Investigational aQII-11 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Units
Counts
Participants
OG00097
OG001107
OG002108
OG003103
OG004106
OG005107
OG006101
OG007109
Title
Denominators
Categories
Any Serious Unsolicited AE
Title
Measurements
OG0004
OG0010
OG0021
OG0031
OG0040
OG0050
OG0060
OG0070
Any Unsolicited AE of Special Interest
Title
Measurements
OG0001
OG0010
OG0020
OG003
Any Medically Attended AE
Title
Measurements
OG00013
OG0015
OG0025
OG003
Any Unsolicited AE Leading to Withdrawal from the Study
Title
Measurements
OG0001
OG0010
OG0020
OG003
Any deaths
Title
Measurements
OG0001
OG0010
OG0020
OG003
OG003
Group C aQII-6 Investigational
aQII-6 Investigational: Biological/Vaccine: Investigational aQII-6 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG004
Group F aQII-10 Investigational
aQII-10 Investigational: Biological/Vaccine: Investigational aQII-10 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG005
Group B aQII-3 Investigational
aQII-3 Investigational: Biological/Vaccine: Investigational aQII-3 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG006
Group D aQII-7 Investigational
aQII-7 Investigational: Biological/Vaccine: Investigational aQII-7 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG007
Group G aQII-11 Investigational
aQII-11 Investigational: Biological/Vaccine: Investigational aQII-11 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Units
Counts
Participants
OG00097
OG001107
OG002108
OG003103
OG004106
OG005107
OG006101
OG007109
Title
Denominators
Categories
Any Serious Unsolicited AE
Title
Measurements
OG0008
OG0011
OG0021
OG0033
OG0045
OG0053
OG0062
OG0072
Any Related Serious Unsolicited AE
Title
Measurements
OG0000
OG0010
OG0020
OG003
Any Unsolicited AE of Special Interest
Title
Measurements
OG0001
OG0010
OG0020
OG003
Any Medically Attended AE
Title
Measurements
OG00020
OG00115
OG00213
OG003
Any Unsolicited AE Leading to Withdrawal from the Study
Title
Measurements
OG0001
OG0010
OG0020
OG003
Deaths
Title
Measurements
OG0001
OG0010
OG0020
OG003
OG003
Group C aQII-6 Investigational
aQII-6 Investigational: Biological/Vaccine: Investigational aQII-6 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG004
Group F aQII-10 Investigational
aQII-10 Investigational: Biological/Vaccine: Investigational aQII-10 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG005
Group B aQII-3 Investigational
aQII-3 Investigational: Biological/Vaccine: Investigational aQII-3 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG006
Group D aQII-7 Investigational
aQII-7 Investigational: Biological/Vaccine: Investigational aQII-7 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG007
Group G aQII-11 Investigational
aQII-11 Investigational: Biological/Vaccine: Investigational aQII-11 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Units
Counts
Participants
OG00095
OG001105
OG002106
OG00399
OG004102
OG005104
OG00695
OG007104
Title
Denominators
Categories
A/H1N1 Day 1
Title
Measurements
OG00044.55(34.6 to 57.4)
OG00129.77(23.4 to 37.9)
OG00231.77(25.0 to 40.3)
OG00339.02(30.4 to 50.0)
OG00432.29(25.3 to 41.2)
OG00532.99(25.9 to 42.0)
OG00630.44(23.6 to 39.2)
OG00732.49(25.5 to 41.4)
A/H1N1 Day 29
Title
Measurements
OG000476.69(351.4 to 646.6)
OG001495.34(370.7 to 661.8)
OG002430.24(322.8 to 573.4)
OG003
B/Yamagata Day 1
Title
Measurements
OG00014.80(12.8 to 17.2)
OG00115.53(13.5 to 17.9)
OG00218.04(15.7 to 20.8)
OG003
B/Yamagata Day 29
Title
Measurements
OG00043.60(37.6 to 50.5)
OG00143.1(37.5 to 49.6)
OG00256.7(49.4 to 65.1)
OG003
B/Victoria Day 1
Title
Measurements
OG00035.10(28.1 to 43.9)
OG00143.96(35.5 to 54.4)
OG00238.15(30.9 to 47.1)
OG003
B/Victoria Day 29
Title
Measurements
OG000112.86(93.4 to 136.3)
OG001117.97(98.5 to 141.2)
OG002157.54(131.8 to 188.3)
OG003
OG003
Group F aQII-10 Investigational
aQII-10 Investigational: Biological/Vaccine: Investigational aQII-10 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG004
Group B aQII-3 Investigational
aQII-3 Investigational: Biological/Vaccine: Investigational aQII-3 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG005
Group D aQII-7 Investigational
aQII-7 Investigational: Biological/Vaccine: Investigational aQII-7 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG006
Group G aQII-11 Investigational
aQII-11 Investigational: Biological/Vaccine: Investigational aQII-11 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Units
Counts
Participants
OG000105
OG001106
OG00299
OG003102
OG004104
OG00595
OG006104
Title
Denominators
Categories
A/H1N1 GMR (aQII/QII)
Title
Measurements
OG0001.04(0.68 to 1.58)
OG0010.90(0.59 to 1.37)
OG0021.25(0.82 to 1.91)
OG0031.39(0.91 to 2.11)
OG0041.33(0.87 to 2.03)
OG0051.53(1.00 to 2.35)
OG0060.98(0.64 to 1.49)
B/Yamagata GMR (aQII/QII)
Title
Measurements
OG0000.99(0.81 to 1.21)
OG0011.30(1.06 to 1.59)
OG0021.24(1.01 to 1.53)
OG003
B/Victoria GMR (aQII/QII)
Title
Measurements
OG0001.05(0.81 to 1.36)
OG0011.40(1.08 to 1.81)
OG0021.49(1.15 to 1.94)
OG003
aQII-9 Investigational: Biological/Vaccine: Investigational aQII-9 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG003
Group C aQII-6 Investigational
aQII-6 Investigational: Biological/Vaccine: Investigational aQII-6 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG004
Group F aQII-10 Investigational
aQII-10 Investigational: Biological/Vaccine: Investigational aQII-10 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG005
Group B aQII-3 Investigational
aQII-3 Investigational: Biological/Vaccine: Investigational aQII-3 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG006
Group D aQII-7 Investigational
aQII-7 Investigational: Biological/Vaccine: Investigational aQII-7 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG007
Group G aQII-11 Investigational
aQII-11 Investigational: Biological/Vaccine: Investigational aQII-11 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Units
Counts
Participants
OG00095
OG001105
OG002106
OG00399
OG004102
OG005104
OG00695
OG007104
Title
Denominators
Categories
A/H1N1 Day 29
Title
Measurements
OG00073.7(63.6 to 82.2)
OG00182.9(74.3 to 89.5)
OG00282.1(73.4 to 88.8)
OG00379.8(70.5 to 87.2)
OG00487.3(79.2 to 93.0)
OG00583.7(75.1 to 90.2)
OG00687.4(79.0 to 93.3)
OG00787.5(79.6 to 93.2)
B/Yamagata Day 29
Title
Measurements
OG00031.6(22.4 to 41.9)
OG00127.6(19.3 to 37.2)
OG00239.6(30.3 to 49.6)
OG003
B/Victoria Day 29
Title
Measurements
OG00037.9(28.1 to 48.4)
OG00135.2(26.2 to 45.2)
OG00248.1(38.3 to 58.0)
OG003
OG003
Group C aQII-6 Investigational
aQII-6 Investigational: Biological/Vaccine: Investigational aQII-6 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG004
Group F aQII-10 Investigational
aQII-10 Investigational: Biological/Vaccine: Investigational aQII-10 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG005
Group B aQII-3 Investigational
aQII-3 Investigational: Biological/Vaccine: Investigational aQII-3 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG006
Group D aQII-7 Investigational
aQII-7 Investigational: Biological/Vaccine: Investigational aQII-7 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG007
Group G aQII-11 Investigational
aQII-11 Investigational: Biological/Vaccine: Investigational aQII-11 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Units
Counts
Participants
OG00094
OG001106
OG002105
OG00399
OG004102
OG00597
OG00694
OG007102
Title
Denominators
Categories
A/H1N1 Day 181
Title
Measurements
OG000110.69(89.3 to 137.2)
OG00195.07(77.7 to 116.3)
OG00278.87(64.4 to 96.5)
OG00386.67(70.3 to 106.8)
OG00492.45(75.3 to 113.5)
OG00578.23(63.4 to 96.6)
OG00685.50(69.0 to 105.9)
OG00786.67(70.6 to 106.5)
B/Yamagata Day 181
Title
Measurements
OG00025.05(21.3 to 29.5)
OG00126.58(22.8 to 31.0)
OG00226.71(22.9 to 31.2)
OG003
B/Victoria Day 181
Title
Measurements
OG00055.42(44.5 to 69.1)
OG00153.30(43.3 to 65.6)
OG00259.26(48.2 to 72.9)
OG003
OG003
Group F aQII-10 Investigational
aQII-10 Investigational: Biological/Vaccine: Investigational aQII-10 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG004
Group B aQII-3 Investigational
aQII-3 Investigational: Biological/Vaccine: Investigational aQII-3 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG005
Group D aQII-7 Investigational
aQII-7 Investigational: Biological/Vaccine: Investigational aQII-7 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG006
Group G aQII-11 Investigational
aQII-11 Investigational: Biological/Vaccine: Investigational aQII-11 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Units
Counts
Participants
OG000106
OG001105
OG00299
OG003102
OG00497
OG00594
OG006102
Title
Denominators
Categories
A/H1N1 Day 181 (aQII/QII)
Title
Measurements
OG0000.86(0.64 to 1.15)
OG0010.71(0.53 to 0.96)
OG0020.78(0.58 to 1.05)
OG0030.84(0.62 to 1.12)
OG0040.71(0.52 to 0.95)
OG0050.77(0.57 to 1.04)
OG0060.78(0.58 to 1.05)
B/Yamagata Day 181 (aQII/QII)
Title
Measurements
OG0001.06(0.85 to 1.33)
OG0011.07(0.85 to 1.34)
OG0020.99(0.79 to 1.25)
OG003
B/Victoria Day 181 (aQII/QII)
Title
Measurements
OG0000.96(0.71 to 1.30)
OG0011.07(0.79 to 1.45)
OG0021.01(0.74 to 1.37)
OG003
OG003
Group C aQII-6 Investigational
aQII-6 Investigational: Biological/Vaccine: Investigational aQII-6 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG004
Group F aQII-10 Investigational
aQII-10 Investigational: Biological/Vaccine: Investigational aQII-10 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG005
Group B aQII-3 Investigational
aQII-3 Investigational: Biological/Vaccine: Investigational aQII-3 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG006
Group D aQII-7 Investigational
aQII-7 Investigational: Biological/Vaccine: Investigational aQII-7 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG007
Group G aQII-11 Investigational
aQII-11 Investigational: Biological/Vaccine: Investigational aQII-11 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Units
Counts
Participants
OG00094
OG001106
OG002105
OG00399
OG004102
OG00597
OG00694
OG007102
Title
Denominators
Categories
A/H1N1 Day 181
Title
Measurements
OG00087.2(78.8 to 93.2)
OG00185.8(77.7 to 91.9)
OG00280.0(71.1 to 87.2)
OG00382.8(73.9 to 89.7)
OG00487.3(79.2 to 93.0)
OG00580.4(71.1 to 87.8)
OG00683.0(73.8 to 89.9)
OG00781.4(72.4 to 88.4)
B/Yamagata Day 181
Title
Measurements
OG00042.6(32.4 to 53.2)
OG00142.5(32.9 to 52.4)
OG00249.5(39.6 to 59.5)
OG003
B/Victoria Day 181
Title
Measurements
OG00071.3(61.0 to 80.1)
OG00175.5(66.2 to 83.3)
OG00274.3(64.8 to 82.3)
OG003
OG003
Group C aQII-6 Investigational
aQII-6 Investigational: Biological/Vaccine: Investigational aQII-6 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG004
Group F aQII-10 Investigational
aQII-10 Investigational: Biological/Vaccine: Investigational aQII-10 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG005
Group B aQII-3 Investigational
aQII-3 Investigational: Biological/Vaccine: Investigational aQII-3 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG006
Group D aQII-7 Investigational
aQII-7 Investigational: Biological/Vaccine: Investigational aQII-7 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG007
Group G aQII-11 Investigational
aQII-11 Investigational: Biological/Vaccine: Investigational aQII-11 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
Units
Counts
Participants
OG00094
OG001106
OG002105
OG00399
OG004102
OG00597
OG00694
OG007102
Title
Denominators
Categories
A/H1N1 Day 181
Title
Measurements
OG000516.06(382.5 to 696.2)
OG001529.64(399.8 to 701.7)
OG002427.95(322.9 to 567.2)
OG003615.44(459.8 to 823.7)
OG004562.64(422.6 to 749.1)
OG005518.67(386.8 to 695.5)
OG006644.81(478.4 to 869.0)
OG007493.66(370.8 to 657.3)
A/H3N2 Day 181
Title
Measurements
OG00073.72(60.7 to 89.5)
OG00170.50(58.7 to 84.6)
OG00274.71(62.2 to 89.7)
OG003
B/Yamagata Day 181
Title
Measurements
OG00026.19(22.8 to 30.1)
OG00126.38(23.1 to 30.1)
OG00228.53(25.0 to 32.5)
OG003
B/Victoria Day 181
Title
Measurements
OG000175.30(146.4 to 209.9)
OG001180.26(152.1 to 213.6)
OG002209.57(176.8 to 248.4)
OG003
OG003
Group F aQII-10 Investigational
aQII-10 Investigational: Biological/Vaccine: Investigational aQII-10 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG004
Group B aQII-3 Investigational
aQII-3 Investigational: Biological/Vaccine: Investigational aQII-3 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG005
Group D aQII-7 Investigational
aQII-7 Investigational: Biological/Vaccine: Investigational aQII-7 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
OG006
Group G aQII-11 Investigational
aQII-11 Investigational: Biological/Vaccine: Investigational aQII-11 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.