A Study to Assess the Safety and Immune Response of a Vac... | NCT05823974 | Trialant
NCT05823974
Sponsor
GlaxoSmithKline
Status
Completed
Last Update Posted
Jul 23, 2025Actual
Enrollment
1,275Actual
Phase
Phase 1Phase 2
Conditions
Influenza, Human
Interventions
F2C22C/DL001Z
F2B22A/DL001Z
F2B22B/DL001Z
F2B22C/DL001Z
F2B22D/DL001Z
F2B22E/DL001Z
F2F22A/DL001Z
F2F22B/DL001Z
F2F22C/DL001Z
F2F22D/DL001Z
F2F22E/DL001Z
Control 1
F2F23D/DL001Z-NH
F2F23A/DL001Z-NH
F2F23B/DL001Z-NH
Control 2
F2F23C/DL001Z-NH
Control 3
F2F22F/DL001Z
Countries
United States
Belgium
Canada
South Africa
Protocol Section
Identification Module
NCT ID
NCT05823974
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
217884
Secondary IDs
ID
Type
Description
Link
2022-502308-66-00
Other Identifier
EU CT Number
Brief Title
A Study to Assess the Safety and Immune Response of a Vaccine Against Influenza in Healthy Younger and Older Adults
Official Title
A Phase 1/2, Randomized, Dose-finding/Dose-confirmation Study to Evaluate the Reactogenicity, Safety and Immunogenicity of mRNA-based Multivalent Seasonal Influenza Vaccine Candidates Administered in Healthy Younger and Older Adults
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Jun 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 27, 2023Actual
Primary Completion Date
Jul 2, 2024Actual
Completion Date
Dec 18, 2024Actual
First Submitted Date
Apr 11, 2023
First Submission Date that Met QC Criteria
Apr 11, 2023
First Posted Date
Apr 21, 2023Actual
Results Waived
Not provided
Results First Submitted Date
Jul 1, 2025
Results First Submitted that Met QC Criteria
Jul 1, 2025
Results First Posted Date
Jul 23, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jul 1, 2025
Last Update Posted Date
Jul 23, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
Collaborators
Name
Class
CureVac
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
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
No
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to find and confirm the dose and asses the reactogenicity, safety and immune response of GlaxoSmithKline's (GSK) messenger RNA (mRNA)-based multivalent seasonal influenza vaccine (GSK4382276A) candidates administered in healthy younger and older adults (OA).
Detailed Description
Not provided
Conditions Module
Conditions
Influenza, Human
Keywords
Influenza
Safety
Reactogenicity
Immunogenicity
mRNA vaccine
Healthy younger adults
Healthy older adults
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,275Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Flu mRNA_Ph1_1 Younger Adults (YA) Group
Experimental
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
Biological: F2C22C/DL001Z
Flu mRNA_Ph1_2 YA Group
Experimental
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
Biological: F2B22A/DL001Z
Flu mRNA_Ph1_3 YA Group
Experimental
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
Biological: F2B22B/DL001Z
Flu mRNA_Ph1_4 YA Group
Experimental
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
Biological: F2B22C/DL001Z
Flu mRNA_Ph1_5 YA Group
Experimental
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
F2C22C/DL001Z
Biological
Study intervention was administered intramuscularly in Phase 1, at Day 1.
Flu mRNA_Ph1_1 Younger Adults (YA) Group
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs)
Assessed solicited administration site events included pain, redness (Erythema), swelling, lymphadenopathy (defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm). Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.
Day 1 to Day 7
Number of Participants Reporting Any Solicited Systemic AEs
Assessed solicited systemic events included fever (defined as axillary temperature greater than or equal to (>=) 38.0°C/100.4°F), chills, headache, fatigue, myalgia, and arthralgia. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.
Day 1 to Day 7
Number of Participants Reporting Any Unsolicited AEs
An unsolicited AE is defined as an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow up for solicited events. Unsolicited AEs include both serious and non-serious AEs. Any = occurrence the event regardless of intensity grade or relation to the study vaccination.
Day 1 to Day 28
Number of Participants Reporting Serious Adverse Events (SAEs)
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, is an abnormal pregnancy outcome, or is a suspected transmission of any infectious agent via an authorized medicinal product. Any = occurrence the event regardless of intensity grade or relation to the study vaccination.
Day 1 to Day 183
Number of Participants Reporting AEs of Special Interest (AESIs)
Secondary Outcomes
Measure
Description
Time Frame
GMT of Antigen 1 Antibody Titer
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
At Day 92
GMT of Antigen 1 Antibody Titer
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
A male or female between and including 18 and 50 years of age in Phase 1 and between and including 18 and 85 years of age (YA: 18-64; OA: 65-85) in Phase 2 at the time of the study intervention administration.
Healthy participants or medically stable participants as established by medical history, clinical examination, and safety laboratory assessments. Participants with chronic medical conditions with or without specific treatment are allowed to participate in this study if considered by the investigator as medically stable. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during 3 months before enrollment.
Body mass index (BMI) >=18 kilograms per meter square (kg/m^2) and less than or equal to (<=) 35 kg/m^2.
Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
Written informed consent obtained from the participant prior to performing any study-specific procedure.
Female participants of non-childbearing potential may be enrolled in the study.
Female participants of childbearing potential may be enrolled in the study if the participant:
has practiced adequate contraception for 28 days prior to study intervention administration, and
has a negative pregnancy test on the day of study intervention administration, and
has agreed to continue adequate contraception for at least 1 month after study intervention administration
Exclusion Criteria:
Medical conditions
Only in Phase 1: Any clinically significant* hematological, biochemical, urinalysis or (hemoglobin A1c) HbA1c laboratory abnormality.
*The investigator should use the clinical judgment to decide which abnormalities are clinically significant.
Participant tested positive for influenza by local health authority-approved testing methods within 180 days prior to Day 1.
Current or past malignancy, unless completely resolved without clinically significant sequelae for >5 years.
Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection, based on medical history and physical examination (no laboratory testing required). However, in Phase 2, HIV-infected individuals may be enrolled if participants have been stable on antiretroviral therapy for the past 6 consecutive months, i.e., their treatment has not been modified, their cluster of differentiation 4 (CD4) cell count is >=200/cubic millimeter (mm^3) and their viral load has been undetectable (i.e., HIV-RNA less than (<) 50 copies/milliliter [mL]) (based on medical records, no laboratory testing required).
History of myocarditis or pericarditis less than or equal to 10 years prior to vaccine administration, including a history of myocarditis or pericarditis following vaccination with an mRNA coronavirus disease 2019 (COVID-19) vaccine.
Participants with history of hypersensitivity or severe allergic reaction to any previous vaccine or hypersensitivity likely to be exacerbated by any component of the study intervention (including latex, polyethylene glycol, egg protein and aminoglycoside antibiotics).
Any history of dementia or any medical condition that moderately or severely impairs cognition.
Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
Prior/Concomitant therapy
Administration of an influenza vaccine (including any of the study investigational vaccines) within 180 days before enrollment or planned administration within 28 days (Day 29) after the study intervention administration.
Phase 1: Administration of a vaccine not foreseen by the study protocol in the period starting 28 days (Day -28) before the study intervention administration or planned administration within 28 days (Day 29) after the study intervention administration. Phase 2: Administration of a vaccine not foreseen by the study protocol in the period starting 15 days (Day -15) before the study intervention administration or planned administration within 28 days (Day 29) after the study intervention administration.
*In case emergency mass vaccination for an unforeseen public health threat is recommended and/or organized by public health authorities outside the routine immunization program, the time period described above can be reduced to 7 days if, necessary for that vaccine, provided it is used according to the local governmental recommendations and that the Sponsor is notified accordingly.
Use of any investigational or non-registered product (drug, vaccine, or invasive medical device) other than the study intervention during the period beginning 30 days before the study intervention administration, or their planned use during the study period.
Administration of long-acting immune-modifying drugs within 90 days before enrollment or planned use at any time during the study period.
Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the study intervention administration, or planned administration during the study period. Administration of monoclonal antibodies specifically directed against the spike protein of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), for treatment of COVID-19 disease is allowed.
Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the study intervention administration. For corticosteroids, this will mean prednisone equivalent >=20 milligrams (mg)/day. Inhaled, topical and intraarticular steroids are allowed.
Other exclusions
Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/invasive medical device).
Pregnant or lactating female.
Bedridden participants.
Female planning to become pregnant or planning to discontinue contraceptive precautions within the 1-month post-dosing period.
Alcoholism or substance use disorder within the past 24 months based on the presence of 2 or more of the following abuse criteria: hazardous use, social/interpersonal problems related to use, neglect of major roles to use, withdrawal, tolerance, use of larger amounts or longer, repeated attempts to quit or control use, much time spent using, physical or psychological problems related to use, activities given up to use, craving.
Any study personnel or their immediate dependents, family, or household members.
Participants with extensive tattoos covering deltoid region on both arms that would preclude the assessment of local reactogenicity.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
85 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
GSK Clinical Trials
GlaxoSmithKline
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
GSK Investigational Site
Hialeah
Florida
33012
United States
GSK Investigational Site
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Types
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Access Criteria
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
Biological: F2B22E/DL001Z
Flu mRNA_Ph1_7 YA Group
Experimental
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
Biological: F2F22A/DL001Z
Flu mRNA_Ph1_8 YA Group
Experimental
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
Biological: F2F22B/DL001Z
Flu mRNA_Ph1_9 YA Group
Experimental
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
Biological: F2F22C/DL001Z
Flu mRNA_Ph1_10 YA Group
Experimental
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
Biological: F2F22D/DL001Z
Flu mRNA_Ph1_11 YA Group
Experimental
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
Biological: F2F22E/DL001Z
Flu mRNA_Ph1_12 YA Group
Experimental
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
Biological: F2F22F/DL001Z
Control Ph1_YA Group
Active Comparator
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
Combination Product: Control 1
Flu mRNA_Ph2_1_YA Group
Experimental
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
Biological: F2F23D/DL001Z-NH
Flu mRNA_Ph2_2_YA Group
Experimental
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
Biological: F2F23A/DL001Z-NH
Flu mRNA_Ph2_3_YA Group
Experimental
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
Biological: F2F23B/DL001Z-NH
Control_Ph2_YA Group
Active Comparator
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
Combination Product: Control 2
Flu mRNA_Ph2_1_Older adults (OA) Group
Experimental
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
Biological: F2F23A/DL001Z-NH
Flu mRNA_Ph2_2_OA Group
Experimental
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
Biological: F2F23B/DL001Z-NH
Flu mRNA_Ph2_3_OA Group
Experimental
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
Biological: F2F23C/DL001Z-NH
Control_Ph2_OA Group
Active Comparator
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
Combination Product: Control 3
F2B22A/DL001Z
Biological
Study intervention was administered intramuscularly in Phase 1, at Day 1.
Flu mRNA_Ph1_2 YA Group
F2B22B/DL001Z
Biological
Study intervention was administered intramuscularly in Phase 1, at Day 1.
Flu mRNA_Ph1_3 YA Group
F2B22C/DL001Z
Biological
Study intervention was administered intramuscularly in Phase 1, at Day 1.
Flu mRNA_Ph1_4 YA Group
F2B22D/DL001Z
Biological
Study intervention was administered intramuscularly in Phase 1, at Day 1.
Flu mRNA_Ph1_5 YA Group
F2B22E/DL001Z
Biological
Study intervention was administered intramuscularly in Phase 1, at Day 1.
Flu mRNA_Ph1_6 YA Group
F2F22A/DL001Z
Biological
Study intervention was administered intramuscularly in Phase 1, at Day 1.
Flu mRNA_Ph1_7 YA Group
F2F22B/DL001Z
Biological
Study intervention was administered intramuscularly in Phase 1, at Day 1.
Flu mRNA_Ph1_8 YA Group
F2F22C/DL001Z
Biological
Study intervention was administered intramuscularly in Phase 1, at Day 1.
Flu mRNA_Ph1_9 YA Group
F2F22D/DL001Z
Biological
Study intervention was administered intramuscularly in Phase 1, at Day 1.
Flu mRNA_Ph1_10 YA Group
F2F22E/DL001Z
Biological
Study intervention was administered intramuscularly in Phase 1, at Day 1.
Flu mRNA_Ph1_11 YA Group
Control 1
Combination Product
Control vaccine was administered intramuscularly in Phase 1, at Day 1.
Control Ph1_YA Group
F2F23D/DL001Z-NH
Biological
Study intervention was administered intramuscularly in Phase 2, at Day 1.
Flu mRNA_Ph2_1_YA Group
F2F23A/DL001Z-NH
Biological
Study intervention was administered intramuscularly in Phase 2, at Day 1.
Flu mRNA_Ph2_1_Older adults (OA) Group
Flu mRNA_Ph2_2_YA Group
F2F23B/DL001Z-NH
Biological
Study intervention was administered intramuscularly in Phase 2, at Day 1.
Flu mRNA_Ph2_2_OA Group
Flu mRNA_Ph2_3_YA Group
Control 2
Combination Product
Control vaccine was administered intramuscularly in Phase 2, at Day 1.
Control_Ph2_YA Group
F2F23C/DL001Z-NH
Biological
Study intervention was administered intramuscularly in Phase 2, at Day 1.
Flu mRNA_Ph2_3_OA Group
Control 3
Combination Product
Control vaccine was administered intramuscularly in Phase 2, at Day 1.
Control_Ph2_OA Group
F2F22F/DL001Z
Biological
Study intervention was administered intramuscularly in Phase 1, at Day 1.
Flu mRNA_Ph1_12 YA Group
The following events were considered as AESI in this study: severe hypersensitivity reactions within 24 hours after study intervention administration, myocarditis/pericarditis and potential immune-mediated diseases (pIMDs). Any = occurrence the event regardless of intensity grade or relation to the study vaccination.
Day 1 to Day 183
Number of Participants Reporting Medically Attended Events (MAEs)
MAE is defined as an AE that results in an unscheduled visit to a medical professional (e.g., physician's office visits, emergency room visits or hospitalization). Any = occurrence the event regardless of intensity grade or relation to the study vaccination.
Day 1 to Day 183
Number of Participants Reporting a Shift From Abnormal Non-clinically Significant and Normal or Missing Laboratory Value on Day 1 to Clinically Significant Abnormal Laboratory Value on Day 8 for Hematology, and Clinical Chemistry
Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participants condition. Normal or missing values refer to laboratory values that were within normal range or missing at baseline.
At Day 8 compared to baseline (Day 1)
Number of Participants Reporting a Shift From Abnormal Non-clinically Significant and Normal or Missing Laboratory Value on Day 1 to Clinically Significant Abnormal Laboratory Value on Day 29 for Hematology, and Clinical Chemistry
Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participants condition. Normal or missing values refer to laboratory values that were within normal range or missing at baseline.
At Day 29 compared to baseline (Day 1)
Geometric Mean Titer (GMT) of Antigen 1 Antibody Titer
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
At Day 29
Geometric Mean Increase (GMI) of Antigen 1 Antibody Titers From Day 1 to Day 29
GMI is defined as the geometric mean of the ratios of the post dosing titer over the Day 1 titer. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
From Day 1 (baseline) to Day 29
Percentage of Participants With Antigen 1 Antibody Seroconversion Rate (SCR)
SCR is defined as the percentage of dosed participants who have either an anti-vaccine antibody pre-dose titer < 1:10 and a post-dose anti-vaccine antibody titer >= 1:40 or a pre-dose anti-vaccine antibody titer >= 1:10 and at least a 4-fold increase in post-dose anti-vaccine antibody titer. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
From Day 1 to Day 29
Percentage of Participants With Antigen 1 Antibody Seroprotection Rate (SPR)
SPR is defined as the percentage of dosed participants with a anti-vaccine antibody titer >= 1:40. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
At Day 1
Percentage of Participants With Antigen 1 Antibody SPR
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
At Day 29
GMT of Antigen 2 Antibody Titer
At Day 29
GMI of Antigen 2 Antibody Titer From Day 1 to Day 29
From Day 1 (baseline) to Day 29
Percentage of Participants With Antigen 2 Antibody SCR
From Day 1 to Day 29
At Day 183
GMI of Antigen 1 Antibody Titer From Day 1 to Day 92
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
From Day 1 (baseline) to Day 92
GMI of Antigen 1 Antibody Titer From Day 1 to Day 183
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
From Day 1 (baseline) to Day 183
Percentage of Participants With Antigen 1 Antibody SPR
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
FG002
Flu mRNA_Ph1_3 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
FG003
Flu mRNA_Ph1_4 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
FG004
Flu mRNA_Ph1_5 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
FG005
Flu mRNA_Ph1_6 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
FG006
Flu mRNA_Ph1_7 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
FG007
Flu mRNA_Ph1_8 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
FG008
Flu mRNA_Ph1_9 YA Group
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
FG009
Flu mRNA_Ph1_10 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
FG010
Flu mRNA_Ph1_11 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
FG011
Flu mRNA_Ph1_12 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
FG012
Control Ph1_YA Group
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
FG013
Flu mRNA_Ph2_1_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
FG014
Flu mRNA_Ph2_2_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1
FG015
Flu mRNA_Ph2_3_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
FG016
Control_Ph2_YA Group
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
FG017
Flu mRNA_Ph2_1_Older Adults (OA) Group
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
FG018
Flu mRNA_Ph2_2_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
FG019
Flu mRNA_Ph2_3_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
FG020
Control_Ph2_OA Group
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
FG00021 subjects
FG00122 subjects
FG00223 subjects
FG00323 subjects
FG00422 subjects
FG00525 subjects
FG00623 subjects
FG00722 subjects
FG00823 subjects
FG00922 subjects
FG01023 subjects
FG01121 subjects
FG01223 subjects
FG013115 subjects
FG014108 subjects
FG015137 subjects
FG016120 subjects
FG017119 subjects
FG018122 subjects
FG019125 subjects
FG020117 subjects
COMPLETED
FG00020 subjects
FG00117 subjects
FG00218 subjects
FG00322 subjects
FG00419 subjects
FG00521 subjects
FG00620 subjects
FG00720 subjects
FG00820 subjects
FG00920 subjects
FG01021 subjects
FG01121 subjects
FG01220 subjects
FG013111 subjects
FG014105 subjects
FG015131 subjects
FG016119 subjects
FG017116 subjects
FG018119 subjects
FG019123 subjects
FG020116 subjects
NOT COMPLETED
FG0001 subjects
FG0015 subjects
FG0025 subjects
FG0031 subjects
FG0043 subjects
FG0054 subjects
FG0063 subjects
FG0072 subjects
FG0083 subjects
FG0092 subjects
FG0102 subjects
FG0110 subjects
FG0123 subjects
FG0134 subjects
FG0143 subjects
FG0156 subjects
FG0161 subjects
FG0173 subjects
FG0183 subjects
FG0192 subjects
FG0201 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0013 subjects
FG0021 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
FG0101 subjects
FG0110 subjects
FG0121 subjects
FG0132 subjects
FG0141 subjects
FG0151 subjects
FG0161 subjects
FG0170 subjects
FG0180 subjects
FG0192 subjects
FG0200 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0011 subjects
FG0022 subjects
FG0030 subjects
FG004
MIGRATED / MOVED FROM THE STUDY AREA
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Other
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Flu mRNA_Ph1_1 Younger Adults (YA) Group
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
BG001
Flu mRNA_Ph1_2 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
BG002
Flu mRNA_Ph1_3 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
BG003
Flu mRNA_Ph1_4 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
BG004
Flu mRNA_Ph1_5 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
BG005
Flu mRNA_Ph1_6 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
BG006
Flu mRNA_Ph1_7 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
BG007
Flu mRNA_Ph1_8 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
BG008
Flu mRNA_Ph1_9 YA Group
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
BG009
Flu mRNA_Ph1_10 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
BG010
Flu mRNA_Ph1_11 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
BG011
Flu mRNA_Ph1_12 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
BG012
Control Ph1_YA Group
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
BG013
Flu mRNA_Ph2_1_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
BG014
Flu mRNA_Ph2_2_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1
BG015
Flu mRNA_Ph2_3_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
BG016
Control_Ph2_YA Group
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
BG017
Flu mRNA_Ph2_1_Older Adults (OA) Group
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
BG018
Flu mRNA_Ph2_2_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
BG019
Flu mRNA_Ph2_3_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
BG020
Control_Ph2_OA Group
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
BG021
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00021
BG00122
BG00223
BG00323
BG00422
BG00525
BG00623
BG00722
BG00823
BG00922
BG01023
BG01121
BG01223
BG013115
BG014108
BG015137
BG016120
BG017119
BG018122
BG019125
BG020117
BG0211256
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
18 - 64 years
Title
Measurements
BG00021
BG00122
BG00223
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00012
BG00111
BG002
Race/Ethnicity, Customized
The "All Other Races" category (i.e., American Indian or Alaska Native, Asian and Black or African American for phase 1 YA and phase II YA & OA, where 0\
Count of Participants
Participants
Title
Denominators
Categories
WHITE
Title
Measurements
BG00014
BG001
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
Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs)
Assessed solicited administration site events included pain, redness (Erythema), swelling, lymphadenopathy (defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm). Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.
The analysis was performed on the Exposed Set (ES), which included all participants who received a study intervention and for whom solicited administration site events data were available at specified timepoints.
Posted
Count of Participants
Participants
Day 1 to Day 7
ID
Title
Description
OG000
Flu mRNA_Ph1_1 Younger Adults (YA) Group
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
OG001
Flu mRNA_Ph1_2 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
OG002
Flu mRNA_Ph1_3 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
OG003
Flu mRNA_Ph1_4 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
OG004
Flu mRNA_Ph1_5 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
OG005
Flu mRNA_Ph1_6 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
OG006
Flu mRNA_Ph1_7 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
OG007
Flu mRNA_Ph1_8 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
OG008
Flu mRNA_Ph1_9 YA Group
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
OG009
Flu mRNA_Ph1_10 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
OG010
Flu mRNA_Ph1_11 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
OG011
Flu mRNA_Ph1_12 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
OG012
Control Ph1_YA Group
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
OG013
Flu mRNA_Ph2_1_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
OG014
Flu mRNA_Ph2_2_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1
OG015
Flu mRNA_Ph2_3_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
OG016
Control_Ph2_YA Group
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
OG017
Flu mRNA_Ph2_1_Older Adults (OA) Group
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
OG018
Flu mRNA_Ph2_2_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
OG019
Flu mRNA_Ph2_3_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
OG020
Control_Ph2_OA Group
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
Units
Counts
Participants
OG00021
OG00122
OG00223
OG003
Title
Denominators
Categories
Erythema
Title
Measurements
OG0000
OG0012
OG0022
OG003
Primary
Number of Participants Reporting Any Solicited Systemic AEs
Assessed solicited systemic events included fever (defined as axillary temperature greater than or equal to (>=) 38.0°C/100.4°F), chills, headache, fatigue, myalgia, and arthralgia. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.
The analysis was performed on the ES, which included all participants who received a study intervention and for whom solicited systemic events data were available at specified timepoints.
Posted
Count of Participants
Participants
Day 1 to Day 7
ID
Title
Description
OG000
Flu mRNA_Ph1_1 Younger Adults (YA) Group
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
OG001
Flu mRNA_Ph1_2 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
OG002
Flu mRNA_Ph1_3 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
Primary
Number of Participants Reporting Any Unsolicited AEs
An unsolicited AE is defined as an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow up for solicited events. Unsolicited AEs include both serious and non-serious AEs. Any = occurrence the event regardless of intensity grade or relation to the study vaccination.
The analysis was performed on the ES, which included all participants who received a study intervention and for whom unsolicited AEs data were available at specified timepoints.
Posted
Count of Participants
Participants
Day 1 to Day 28
ID
Title
Description
OG000
Flu mRNA_Ph1_1 Younger Adults (YA) Group
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
OG001
Flu mRNA_Ph1_2 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
OG002
Flu mRNA_Ph1_3 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
Primary
Number of Participants Reporting Serious Adverse Events (SAEs)
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, is an abnormal pregnancy outcome, or is a suspected transmission of any infectious agent via an authorized medicinal product. Any = occurrence the event regardless of intensity grade or relation to the study vaccination.
The analysis was performed on the ES, which included all participants who received a study intervention and for whom SAEs data were available at specified timepoints.
Posted
Count of Participants
Participants
Day 1 to Day 183
ID
Title
Description
OG000
Flu mRNA_Ph1_1 Younger Adults (YA) Group
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
OG001
Flu mRNA_Ph1_2 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
OG002
Flu mRNA_Ph1_3 YA Group
Primary
Number of Participants Reporting AEs of Special Interest (AESIs)
The following events were considered as AESI in this study: severe hypersensitivity reactions within 24 hours after study intervention administration, myocarditis/pericarditis and potential immune-mediated diseases (pIMDs). Any = occurrence the event regardless of intensity grade or relation to the study vaccination.
The analysis was performed on the ES, which included all participants who received a study intervention and for whom AESI data were available at specified timepoints.
Posted
Count of Participants
Participants
Day 1 to Day 183
ID
Title
Description
OG000
Flu mRNA_Ph1_1 Younger Adults (YA) Group
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
OG001
Flu mRNA_Ph1_2 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
OG002
Flu mRNA_Ph1_3 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
Primary
Number of Participants Reporting Medically Attended Events (MAEs)
MAE is defined as an AE that results in an unscheduled visit to a medical professional (e.g., physician's office visits, emergency room visits or hospitalization). Any = occurrence the event regardless of intensity grade or relation to the study vaccination.
The analysis was performed on the ES, which included all participants who received a study intervention and for whom MAEs data were available at specified timepoints.
Posted
Count of Participants
Participants
Day 1 to Day 183
ID
Title
Description
OG000
Flu mRNA_Ph1_1 Younger Adults (YA) Group
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
OG001
Flu mRNA_Ph1_2 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
OG002
Flu mRNA_Ph1_3 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
Primary
Number of Participants Reporting a Shift From Abnormal Non-clinically Significant and Normal or Missing Laboratory Value on Day 1 to Clinically Significant Abnormal Laboratory Value on Day 8 for Hematology, and Clinical Chemistry
Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participants condition. Normal or missing values refer to laboratory values that were within normal range or missing at baseline.
The analysis was performed on the ES, which included all participants who received a study intervention and for whom laboratory data were available at specified timepoints.
Posted
Count of Participants
Participants
At Day 8 compared to baseline (Day 1)
ID
Title
Description
OG000
Flu mRNA_Ph1_1 Younger Adults (YA) Group
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
OG001
Flu mRNA_Ph1_2 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
OG002
Flu mRNA_Ph1_3 YA Group
Primary
Number of Participants Reporting a Shift From Abnormal Non-clinically Significant and Normal or Missing Laboratory Value on Day 1 to Clinically Significant Abnormal Laboratory Value on Day 29 for Hematology, and Clinical Chemistry
Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participants condition. Normal or missing values refer to laboratory values that were within normal range or missing at baseline.
The analysis was performed on the ES, which included all participants who received a study intervention and for whom laboratory data were available for the specified timepoints.
Posted
Count of Participants
Participants
At Day 29 compared to baseline (Day 1)
ID
Title
Description
OG000
Flu mRNA_Ph1_1 Younger Adults (YA) Group
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
OG001
Flu mRNA_Ph1_2 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
OG002
Flu mRNA_Ph1_3 YA Group
Primary
Geometric Mean Titer (GMT) of Antigen 1 Antibody Titer
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
The analysis was performed on the Per Protocol Set (PPS), which included all eligible participants who received the study intervention dose according to the protocol, had recorded anti-HI immunogenicity results pre- and post-dose, without intercurrent conditions, and did not use prohibited medications or vaccinations before Day 29 and for whom data were available for the specified analysis at the specified timepoints. Blood sample results that deviated from the analysis criteria were excluded.
Posted
Geometric Mean
95% Confidence Interval
Titers
At Day 29
ID
Title
Description
OG000
Flu mRNA_Ph1_1 Younger Adults (YA) Group
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
OG001
Flu mRNA_Ph1_2 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
OG002
Flu mRNA_Ph1_3 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
Primary
Geometric Mean Increase (GMI) of Antigen 1 Antibody Titers From Day 1 to Day 29
GMI is defined as the geometric mean of the ratios of the post dosing titer over the Day 1 titer. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
The analysis was performed on the PPS. Only participants with data available for the specified analysis at the specified timepoints were included.
Posted
Geometric Mean
95% Confidence Interval
Ratio
From Day 1 (baseline) to Day 29
ID
Title
Description
OG000
Flu mRNA_Ph1_1 Younger Adults (YA) Group
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
OG001
Flu mRNA_Ph1_2 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
OG002
Flu mRNA_Ph1_3 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
OG003
Primary
Percentage of Participants With Antigen 1 Antibody Seroconversion Rate (SCR)
SCR is defined as the percentage of dosed participants who have either an anti-vaccine antibody pre-dose titer < 1:10 and a post-dose anti-vaccine antibody titer >= 1:40 or a pre-dose anti-vaccine antibody titer >= 1:10 and at least a 4-fold increase in post-dose anti-vaccine antibody titer. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
The analysis was performed on the PPS. Only participants with data available for the specified analysis at the specified timepoints were included.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 to Day 29
ID
Title
Description
OG000
Flu mRNA_Ph1_1 Younger Adults (YA) Group
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
OG001
Flu mRNA_Ph1_2 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
OG002
Flu mRNA_Ph1_3 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
Primary
Percentage of Participants With Antigen 1 Antibody Seroprotection Rate (SPR)
SPR is defined as the percentage of dosed participants with a anti-vaccine antibody titer >= 1:40. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
The analysis was performed on the PPS. Only participants with data available for the specified analysis at the specified timepoints were included.
Posted
Number
95% Confidence Interval
Percentage of participants
At Day 1
ID
Title
Description
OG000
Flu mRNA_Ph1_1 Younger Adults (YA) Group
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
OG001
Flu mRNA_Ph1_2 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
OG002
Flu mRNA_Ph1_3 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
OG003
Primary
Percentage of Participants With Antigen 1 Antibody SPR
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
The analysis was performed on the PPS. Only participants with data available for the specified analysis at the specified timepoints were included.
Posted
Number
95% Confidence Interval
Percentage of participants
At Day 29
ID
Title
Description
OG000
Flu mRNA_Ph1_1 Younger Adults (YA) Group
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
OG001
Flu mRNA_Ph1_2 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
OG002
Flu mRNA_Ph1_3 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
OG003
Flu mRNA_Ph1_4 YA Group
Primary
GMT of Antigen 2 Antibody Titer
The analysis was performed on the PPS. Only participants with data available for the specified analysis at the specified timepoints were included.
Posted
Geometric Mean
95% Confidence Interval
Titers
At Day 29
ID
Title
Description
OG000
Flu mRNA_Ph1_1 Younger Adults (YA) Group
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
OG001
Flu mRNA_Ph1_2 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
OG002
Flu mRNA_Ph1_3 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
OG003
Flu mRNA_Ph1_4 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
Primary
GMI of Antigen 2 Antibody Titer From Day 1 to Day 29
The analysis was performed on the PPS. Only participants with data available for the specified analysis at the specified timepoints were included.
Posted
Geometric Mean
95% Confidence Interval
Ratio
From Day 1 (baseline) to Day 29
ID
Title
Description
OG000
Flu mRNA_Ph1_1 Younger Adults (YA) Group
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
OG001
Flu mRNA_Ph1_2 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
OG002
Flu mRNA_Ph1_3 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
OG003
Flu mRNA_Ph1_4 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
Primary
Percentage of Participants With Antigen 2 Antibody SCR
The analysis was performed on the PPS. Only participants with data available for the specified analysis at the specified timepoints were included.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 to Day 29
ID
Title
Description
OG000
Flu mRNA_Ph1_1 Younger Adults (YA) Group
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
OG001
Flu mRNA_Ph1_2 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
OG002
Flu mRNA_Ph1_3 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
OG003
Flu mRNA_Ph1_4 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
Secondary
GMT of Antigen 1 Antibody Titer
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
The analysis was performed on the PPS. Only participants with data available for the specified analysis at the specified timepoints were included.
Posted
Geometric Mean
95% Confidence Interval
Titers
At Day 92
ID
Title
Description
OG000
Flu mRNA_Ph1_1 Younger Adults (YA) Group
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
OG001
Flu mRNA_Ph1_2 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
OG002
Flu mRNA_Ph1_3 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
OG003
Flu mRNA_Ph1_4 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
Secondary
GMT of Antigen 1 Antibody Titer
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
The analysis was performed on the PPS. Only participants with data available for the specified analysis at the specified timepoints were included.
Posted
Geometric Mean
95% Confidence Interval
Titers
At Day 183
ID
Title
Description
OG000
Flu mRNA_Ph1_1 Younger Adults (YA) Group
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
OG001
Flu mRNA_Ph1_2 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
OG002
Flu mRNA_Ph1_3 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
OG003
Flu mRNA_Ph1_4 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
Secondary
GMI of Antigen 1 Antibody Titer From Day 1 to Day 92
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
The analysis was performed on the PPS. Only participants with data available for the specified analysis at the specified timepoints were included.
Posted
Geometric Mean
95% Confidence Interval
Ratio
From Day 1 (baseline) to Day 92
ID
Title
Description
OG000
Flu mRNA_Ph1_1 Younger Adults (YA) Group
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
OG001
Flu mRNA_Ph1_2 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
OG002
Flu mRNA_Ph1_3 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
OG003
Flu mRNA_Ph1_4 YA Group
Secondary
GMI of Antigen 1 Antibody Titer From Day 1 to Day 183
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
The analysis was performed on the PPS. Only participants with data available for the specified analysis at the specified timepoints were included.
Posted
Geometric Mean
95% Confidence Interval
Ratio
From Day 1 (baseline) to Day 183
ID
Title
Description
OG000
Flu mRNA_Ph1_1 Younger Adults (YA) Group
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
OG001
Flu mRNA_Ph1_2 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
OG002
Flu mRNA_Ph1_3 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
OG003
Flu mRNA_Ph1_4 YA Group
Secondary
Percentage of Participants With Antigen 1 Antibody SPR
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
The analysis was performed on the PPS. Only participants with data available for the specified analysis at the specified timepoints were included.
Posted
Number
95% Confidence Interval
Percentage of participants
At Day 183
ID
Title
Description
OG000
Flu mRNA_Ph1_1 Younger Adults (YA) Group
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
OG001
Flu mRNA_Ph1_2 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
OG002
Flu mRNA_Ph1_3 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
OG003
Flu mRNA_Ph1_4 YA Group
Secondary
GMT of Antigen 2 Antibody Titer
The analysis was performed on the PPS. Only participants with data available for the specified analysis at the specified timepoints were included.
Posted
Geometric Mean
95% Confidence Interval
Titers
At Day 92 and Day 183
ID
Title
Description
OG000
Flu mRNA_Ph1_1 Younger Adults (YA) Group
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
OG001
Flu mRNA_Ph1_2 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
OG002
Flu mRNA_Ph1_3 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
OG003
Flu mRNA_Ph1_4 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
Secondary
GMI of Antigen 2 Antibody Titer
The analysis was performed on the PPS. Only participants with data available for the specified analysis at the specified timepoints were included.
Posted
Geometric Mean
95% Confidence Interval
Ratio
From Day 1 to Day 92 and Day 1 to Day 183
ID
Title
Description
OG000
Flu mRNA_Ph1_1 Younger Adults (YA) Group
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
OG001
Flu mRNA_Ph1_2 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
OG002
Flu mRNA_Ph1_3 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
OG003
Flu mRNA_Ph1_4 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
Time Frame
Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
Description
Not provided
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
Flu mRNA_Ph1_1 Younger Adults (YA) Group
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
0
21
0
21
16
21
EG001
Flu mRNA_Ph1_2 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
0
22
0
22
22
22
EG002
Flu mRNA_Ph1_3 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
0
23
0
23
23
23
EG003
Flu mRNA_Ph1_4 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
0
23
0
23
22
23
EG004
Flu mRNA_Ph1_5 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
0
22
0
22
20
22
EG005
Flu mRNA_Ph1_6 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
0
25
1
25
24
25
EG006
Flu mRNA_Ph1_7 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
0
23
0
23
22
23
EG007
Flu mRNA_Ph1_8 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
0
22
0
22
20
22
EG008
Flu mRNA_Ph1_9 YA Group
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
0
23
0
23
19
23
EG009
Flu mRNA_Ph1_10 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
0
22
0
22
20
22
EG010
Flu mRNA_Ph1_11 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
0
23
0
23
23
23
EG011
Flu mRNA_Ph1_12 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
0
21
1
21
19
21
EG012
Control Ph1_YA Group
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
0
23
0
23
18
23
EG013
Flu mRNA_Ph2_1_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
0
115
0
115
99
115
EG014
Flu mRNA_Ph2_2_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1
0
108
1
108
95
108
EG015
Flu mRNA_Ph2_3_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
0
137
0
137
127
137
EG016
Control_Ph2_YA Group
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
0
120
3
120
89
120
EG017
Flu mRNA_Ph2_1_Older Adults (OA) Group
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
0
119
3
119
83
119
EG018
Flu mRNA_Ph2_2_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
0
122
6
122
88
122
EG019
Flu mRNA_Ph2_3_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
0
125
2
125
91
125
EG020
Control_Ph2_OA Group
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
0
117
2
117
69
117
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Angina unstable
Cardiac disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG0030 events0 affected23 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected25 at risk
EG0060 events0 affected23 at risk
EG0070 events0 affected22 at risk
EG0080 events0 affected23 at risk
EG0090 events0 affected22 at risk
EG0100 events0 affected23 at risk
EG0110 events0 affected21 at risk
EG0120 events0 affected23 at risk
EG0130 events0 affected115 at risk
EG0140 events0 affected108 at risk
EG0150 events0 affected137 at risk
EG0160 events0 affected120 at risk
EG0171 events1 affected119 at risk
EG0180 events0 affected122 at risk
EG0190 events0 affected125 at risk
EG0200 events0 affected117 at risk
Coronary artery disease
Cardiac disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Abdominal pain
Gastrointestinal disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Vomiting
Gastrointestinal disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Enterocolitis viral
Infections and infestations
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Erysipelas
Infections and infestations
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Escherichia infection
Infections and infestations
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Liver abscess
Infections and infestations
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Meningitis
Infections and infestations
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Pneumonia
Infections and infestations
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Wound infection bacterial
Infections and infestations
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Bladder transitional cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Metastases to kidney
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Metastases to lung
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Metastases to spine
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Neuroendocrine carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Nodular melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Parathyroid tumour benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Abortion spontaneous
Pregnancy, puerperium and perinatal conditions
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Depression
Psychiatric disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Insomnia
Psychiatric disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Skin necrosis
Skin and subcutaneous tissue disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Hypertensive emergency
Vascular disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG0030 events0 affected23 at risk
EG0040 events0 affected22 at risk
EG0050 events0 affected25 at risk
EG0060 events0 affected23 at risk
EG0070 events0 affected22 at risk
EG0080 events0 affected23 at risk
EG0090 events0 affected22 at risk
EG0100 events0 affected23 at risk
EG0110 events0 affected21 at risk
EG0120 events0 affected23 at risk
EG0130 events0 affected115 at risk
EG0141 events1 affected108 at risk
EG0150 events0 affected137 at risk
EG0160 events0 affected120 at risk
EG0170 events0 affected119 at risk
EG0180 events0 affected122 at risk
EG0190 events0 affected125 at risk
EG0200 events0 affected117 at risk
Eosinophilia
Blood and lymphatic system disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
v26.0
Systematic Assessment
EG0006 events6 affected21 at risk
EG00110 events10 affected22 at risk
EG0028 events8 affected23 at risk
EG003
Lymphocytosis
Blood and lymphatic system disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Left ventricular hypertrophy
Cardiac disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Palpitations
Cardiac disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Ear pain
Ear and labyrinth disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected23 at risk
EG003
Hyperacusis
Ear and labyrinth disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Vertigo positional
Ear and labyrinth disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Abnormal sensation in eye
Eye disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Blepharitis
Eye disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Lacrimation increased
Eye disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Lens disorder
Eye disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Retinal detachment
Eye disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Abdominal pain
Gastrointestinal disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
v26.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Diarrhoea
Gastrointestinal disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0012 events2 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Diarrhoea haemorrhagic
Gastrointestinal disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Dyspepsia
Gastrointestinal disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Dysphagia
Gastrointestinal disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Flatulence
Gastrointestinal disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Food poisoning
Gastrointestinal disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Frequent bowel movements
Gastrointestinal disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Nausea
Gastrointestinal disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0013 events3 affected22 at risk
EG0021 events1 affected23 at risk
EG003
Oral discomfort
Gastrointestinal disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Oral pain
Gastrointestinal disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Toothache
Gastrointestinal disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Vomiting
Gastrointestinal disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Administration site erythema
General disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0012 events2 affected22 at risk
EG0022 events2 affected23 at risk
EG003
Administration site pain
General disorders
v26.0
Systematic Assessment
EG00015 events15 affected21 at risk
EG00119 events19 affected22 at risk
EG00221 events21 affected23 at risk
EG003
Administration site swelling
General disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Asthenia
General disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Chest discomfort
General disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Chest pain
General disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Chills
General disorders
v26.0
Systematic Assessment
EG0004 events4 affected21 at risk
EG00113 events12 affected22 at risk
EG00211 events11 affected23 at risk
EG003
Exercise tolerance decreased
General disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Fatigue
General disorders
v26.0
Systematic Assessment
EG00010 events10 affected21 at risk
EG00119 events19 affected22 at risk
EG00217 events17 affected23 at risk
EG003
Feeling hot
General disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Hangover
General disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Influenza like illness
General disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Injection site bruising
General disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Injection site erythema
General disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Injection site haemorrhage
General disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Injection site induration
General disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Injection site irritation
General disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Injection site movement impairment
General disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Injection site pain
General disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Injection site paraesthesia
General disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected23 at risk
EG003
Injection site pruritus
General disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Injection site rash
General disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Injection site swelling
General disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Injection site warmth
General disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Malaise
General disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Mass
General disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Pain
General disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Pyrexia
General disorders
v26.0
Systematic Assessment
EG0002 events2 affected21 at risk
EG0012 events2 affected22 at risk
EG0026 events6 affected23 at risk
EG003
Vaccination site pruritus
General disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Vessel puncture site haemorrhage
General disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Hypersensitivity
Immune system disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Seasonal allergy
Immune system disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Acute sinusitis
Infections and infestations
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Anal abscess
Infections and infestations
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Atypical pneumonia
Infections and infestations
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Bronchitis
Infections and infestations
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Bronchitis viral
Infections and infestations
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
COVID-19
Infections and infestations
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Cellulitis
Infections and infestations
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Cystitis
Infections and infestations
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Gastroenteritis
Infections and infestations
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Gastroenteritis viral
Infections and infestations
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Gonorrhoea
Infections and infestations
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Hand-foot-and-mouth disease
Infections and infestations
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Helicobacter infection
Infections and infestations
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Herpes zoster
Infections and infestations
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Hordeolum
Infections and infestations
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Influenza
Infections and infestations
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Laryngitis
Infections and infestations
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Lower respiratory tract infection
Infections and infestations
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Mycoplasma genitalium infection
Infections and infestations
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Nasopharyngitis
Infections and infestations
v26.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Oral herpes
Infections and infestations
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Otitis media
Infections and infestations
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Pharyngitis
Infections and infestations
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Pneumonia
Infections and infestations
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Respiratory tract infection
Infections and infestations
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Rhinitis
Infections and infestations
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Rhinovirus infection
Infections and infestations
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Sinusitis
Infections and infestations
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Skin bacterial infection
Infections and infestations
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Staphylococcal infection
Infections and infestations
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Tonsillitis
Infections and infestations
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Tooth abscess
Infections and infestations
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Tooth infection
Infections and infestations
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Upper respiratory tract infection
Infections and infestations
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Urinary tract infection
Infections and infestations
v26.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Viral rhinitis
Infections and infestations
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Arthropod sting
Injury, poisoning and procedural complications
v26.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Avulsion fracture
Injury, poisoning and procedural complications
v26.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Bone contusion
Injury, poisoning and procedural complications
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Fall
Injury, poisoning and procedural complications
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Meniscus injury
Injury, poisoning and procedural complications
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Procedural dizziness
Injury, poisoning and procedural complications
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Alanine aminotransferase increased
Investigations
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Aspartate aminotransferase increased
Investigations
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
C-reactive protein increased
Investigations
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Fibrin D dimer increased
Investigations
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Lymphocyte count increased
Investigations
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Neutrophil count decreased
Investigations
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Troponin increased
Investigations
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
White blood cell count decreased
Investigations
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
v26.0
Systematic Assessment
EG0003 events3 affected21 at risk
EG00112 events12 affected22 at risk
EG0029 events9 affected23 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
v26.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Costochondritis
Musculoskeletal and connective tissue disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Greater trochanteric pain syndrome
Musculoskeletal and connective tissue disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Limb discomfort
Musculoskeletal and connective tissue disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected23 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
v26.0
Systematic Assessment
EG00010 events10 affected21 at risk
EG00122 events21 affected22 at risk
EG00216 events15 affected23 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Osteopenia
Musculoskeletal and connective tissue disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Plantar fasciitis
Musculoskeletal and connective tissue disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Tendon disorder
Musculoskeletal and connective tissue disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Ageusia
Nervous system disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Dizziness
Nervous system disorders
v26.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Headache
Nervous system disorders
v26.0
Systematic Assessment
EG00013 events11 affected21 at risk
EG00119 events17 affected22 at risk
EG00216 events15 affected23 at risk
EG003
Hyperaesthesia
Nervous system disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Lethargy
Nervous system disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Migraine
Nervous system disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Paraesthesia
Nervous system disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Presyncope
Nervous system disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Restless legs syndrome
Nervous system disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Sciatica
Nervous system disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Abnormal dreams
Psychiatric disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Anxiety
Psychiatric disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Depression
Psychiatric disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Irritability
Psychiatric disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Paranoia
Psychiatric disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Poor quality sleep
Psychiatric disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Dysuria
Renal and urinary disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Pollakiuria
Renal and urinary disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Urinary retention
Renal and urinary disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected22 at risk
EG0021 events1 affected23 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected23 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Dyspnoea at rest
Respiratory, thoracic and mediastinal disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0022 events2 affected23 at risk
EG003
Nasal pruritus
Respiratory, thoracic and mediastinal disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected22 at risk
EG0022 events1 affected23 at risk
EG003
Paranasal sinus discomfort
Respiratory, thoracic and mediastinal disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Paranasal sinus hypersecretion
Respiratory, thoracic and mediastinal disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Pulmonary congestion
Respiratory, thoracic and mediastinal disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
v26.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected23 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected23 at risk
EG003
Throat irritation
Respiratory, thoracic and mediastinal disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0011 events1 affected22 at risk
EG0021 events1 affected23 at risk
EG003
Cold sweat
Skin and subcutaneous tissue disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
v26.0
Systematic Assessment
EG0001 events1 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Sensitive skin
Skin and subcutaneous tissue disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Flushing
Vascular disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Hot flush
Vascular disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Hypertension
Vascular disorders
v26.0
Systematic Assessment
EG0000 events0 affected21 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected23 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
OG004
Flu mRNA_Ph1_5 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
OG005
Flu mRNA_Ph1_6 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
OG006
Flu mRNA_Ph1_7 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
OG007
Flu mRNA_Ph1_8 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
OG008
Flu mRNA_Ph1_9 YA Group
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
OG009
Flu mRNA_Ph1_10 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
OG010
Flu mRNA_Ph1_11 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
OG011
Flu mRNA_Ph1_12 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
OG012
Control Ph1_YA Group
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
OG013
Flu mRNA_Ph2_1_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
OG014
Flu mRNA_Ph2_2_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1
OG015
Flu mRNA_Ph2_3_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
OG016
Control_Ph2_YA Group
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
OG017
Flu mRNA_Ph2_1_Older Adults (OA) Group
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
OG018
Flu mRNA_Ph2_2_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
OG019
Flu mRNA_Ph2_3_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
OG020
Control_Ph2_OA Group
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
Units
Counts
Participants
OG00021
OG00122
OG00223
OG00323
OG00422
OG00525
OG00623
OG00721
OG00823
OG00922
OG01023
OG01121
OG01223
OG013115
OG014108
OG015137
OG016120
OG017119
OG018122
OG019125
OG020117
Title
Denominators
Categories
Arthralgia
Title
Measurements
OG0003
OG00112
OG0028
OG00310
OG00411
OG00510
OG0069
OG00711
OG00811
OG0097
OG0109
OG01110
OG0120
OG01331
OG01437
OG01548
OG01611
OG01715
OG01827
OG01933
OG0209
Chills
Title
Measurements
OG0004
OG00112
OG00211
OG003
Fatigue
Title
Measurements
OG00010
OG00119
OG00217
OG003
Headache
Title
Measurements
OG00011
OG00117
OG00215
OG003
Myalgia
Title
Measurements
OG00010
OG00121
OG00215
OG003
Temperature
Title
Measurements
OG0001
OG0012
OG0026
OG003
OG003
Flu mRNA_Ph1_4 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
OG004
Flu mRNA_Ph1_5 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
OG005
Flu mRNA_Ph1_6 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
OG006
Flu mRNA_Ph1_7 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
OG007
Flu mRNA_Ph1_8 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
OG008
Flu mRNA_Ph1_9 YA Group
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
OG009
Flu mRNA_Ph1_10 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
OG010
Flu mRNA_Ph1_11 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
OG011
Flu mRNA_Ph1_12 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
OG012
Control Ph1_YA Group
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
OG013
Flu mRNA_Ph2_1_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
OG014
Flu mRNA_Ph2_2_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1
OG015
Flu mRNA_Ph2_3_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
OG016
Control_Ph2_YA Group
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
OG017
Flu mRNA_Ph2_1_Older Adults (OA) Group
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
OG018
Flu mRNA_Ph2_2_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
OG019
Flu mRNA_Ph2_3_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
OG020
Control_Ph2_OA Group
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
Units
Counts
Participants
OG00021
OG00122
OG00223
OG00323
OG00422
OG00525
OG00623
OG00722
OG00823
OG00922
OG01023
OG01121
OG01223
OG013115
OG014108
OG015137
OG016120
OG017119
OG018122
OG019125
OG020117
Title
Denominators
Categories
Title
Measurements
OG0007
OG00110
OG0025
OG0037
OG0046
OG00512
OG0064
OG0076
OG00812
OG0098
OG0107
OG0119
OG0127
OG01334
OG01440
OG01560
OG01645
OG01724
OG01822
OG01928
OG02020
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
OG003
Flu mRNA_Ph1_4 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
OG004
Flu mRNA_Ph1_5 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
OG005
Flu mRNA_Ph1_6 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
OG006
Flu mRNA_Ph1_7 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
OG007
Flu mRNA_Ph1_8 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
OG008
Flu mRNA_Ph1_9 YA Group
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
OG009
Flu mRNA_Ph1_10 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
OG010
Flu mRNA_Ph1_11 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
OG011
Flu mRNA_Ph1_12 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
OG012
Control Ph1_YA Group
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
OG013
Flu mRNA_Ph2_1_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
OG014
Flu mRNA_Ph2_2_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1
OG015
Flu mRNA_Ph2_3_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
OG016
Control_Ph2_YA Group
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
OG017
Flu mRNA_Ph2_1_Older Adults (OA) Group
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
OG018
Flu mRNA_Ph2_2_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
OG019
Flu mRNA_Ph2_3_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
OG020
Control_Ph2_OA Group
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
Units
Counts
Participants
OG00021
OG00122
OG00223
OG00323
OG00422
OG00525
OG00623
OG00722
OG00823
OG00922
OG01023
OG01121
OG01223
OG013115
OG014108
OG015137
OG016120
OG017119
OG018122
OG019125
OG020117
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
OG0060
OG0070
OG0080
OG0090
OG0100
OG0111
OG0120
OG0130
OG0141
OG0150
OG0163
OG0173
OG0186
OG0192
OG0202
OG003
Flu mRNA_Ph1_4 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
OG004
Flu mRNA_Ph1_5 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
OG005
Flu mRNA_Ph1_6 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
OG006
Flu mRNA_Ph1_7 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
OG007
Flu mRNA_Ph1_8 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
OG008
Flu mRNA_Ph1_9 YA Group
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
OG009
Flu mRNA_Ph1_10 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
OG010
Flu mRNA_Ph1_11 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
OG011
Flu mRNA_Ph1_12 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
OG012
Control Ph1_YA Group
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
OG013
Flu mRNA_Ph2_1_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
OG014
Flu mRNA_Ph2_2_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1
OG015
Flu mRNA_Ph2_3_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
OG016
Control_Ph2_YA Group
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
OG017
Flu mRNA_Ph2_1_Older Adults (OA) Group
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
OG018
Flu mRNA_Ph2_2_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
OG019
Flu mRNA_Ph2_3_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
OG020
Control_Ph2_OA Group
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
Units
Counts
Participants
OG00021
OG00122
OG00223
OG00323
OG00422
OG00525
OG00623
OG00722
OG00823
OG00922
OG01023
OG01121
OG01223
OG013115
OG014108
OG015137
OG016120
OG017119
OG018122
OG019125
OG020117
Title
Denominators
Categories
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0131
OG0140
OG0150
OG0161
OG0170
OG0180
OG0191
OG0200
OG003
Flu mRNA_Ph1_4 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
OG004
Flu mRNA_Ph1_5 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
OG005
Flu mRNA_Ph1_6 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
OG006
Flu mRNA_Ph1_7 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
OG007
Flu mRNA_Ph1_8 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
OG008
Flu mRNA_Ph1_9 YA Group
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
OG009
Flu mRNA_Ph1_10 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
OG010
Flu mRNA_Ph1_11 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
OG011
Flu mRNA_Ph1_12 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
OG012
Control Ph1_YA Group
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
OG013
Flu mRNA_Ph2_1_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
OG014
Flu mRNA_Ph2_2_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1
OG015
Flu mRNA_Ph2_3_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
OG016
Control_Ph2_YA Group
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
OG017
Flu mRNA_Ph2_1_Older Adults (OA) Group
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
OG018
Flu mRNA_Ph2_2_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
OG019
Flu mRNA_Ph2_3_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
OG020
Control_Ph2_OA Group
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
Units
Counts
Participants
OG00021
OG00122
OG00223
OG00323
OG00422
OG00525
OG00623
OG00722
OG00823
OG00922
OG01023
OG01121
OG01223
OG013115
OG014108
OG015137
OG016120
OG017119
OG018122
OG019125
OG020117
Title
Denominators
Categories
Title
Measurements
OG0003
OG0013
OG0024
OG0033
OG0042
OG0057
OG0063
OG0073
OG0083
OG0093
OG0102
OG0118
OG0126
OG01328
OG01428
OG01529
OG01630
OG01720
OG01821
OG01917
OG02018
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
OG003
Flu mRNA_Ph1_4 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
OG004
Flu mRNA_Ph1_5 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
OG005
Flu mRNA_Ph1_6 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
OG006
Flu mRNA_Ph1_7 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
OG007
Flu mRNA_Ph1_8 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
OG008
Flu mRNA_Ph1_9 YA Group
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
OG009
Flu mRNA_Ph1_10 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
OG010
Flu mRNA_Ph1_11 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
OG011
Flu mRNA_Ph1_12 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
OG012
Control Ph1_YA Group
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
Units
Counts
Participants
OG00021
OG00122
OG00223
OG00323
OG00421
OG00525
OG00623
OG00722
OG00823
OG00921
OG01023
OG01121
OG01223
Title
Denominators
Categories
Abnormal non-significant to clinically significant
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0121
Normal or missing to clinically significant
Title
Measurements
OG0000
OG0011
OG0020
OG003
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
OG003
Flu mRNA_Ph1_4 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
OG004
Flu mRNA_Ph1_5 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
OG005
Flu mRNA_Ph1_6 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
OG006
Flu mRNA_Ph1_7 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
OG007
Flu mRNA_Ph1_8 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
OG008
Flu mRNA_Ph1_9 YA Group
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
OG009
Flu mRNA_Ph1_10 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
OG010
Flu mRNA_Ph1_11 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
OG011
Flu mRNA_Ph1_12 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
OG012
Control Ph1_YA Group
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
Units
Counts
Participants
OG00020
OG00122
OG00222
OG00323
OG00421
OG00525
OG00623
OG00722
OG00821
OG00921
OG01022
OG01121
OG01222
Title
Denominators
Categories
Abnormal non-significant to clinically significant
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0071
OG0080
OG0091
OG0100
OG0110
OG0120
Normal or missing to clinically significant
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG003
Flu mRNA_Ph1_4 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
OG004
Flu mRNA_Ph1_5 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
OG005
Flu mRNA_Ph1_6 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
OG006
Flu mRNA_Ph1_7 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
OG007
Flu mRNA_Ph1_8 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
OG008
Flu mRNA_Ph1_9 YA Group
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
OG009
Flu mRNA_Ph1_10 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
OG010
Flu mRNA_Ph1_11 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
OG011
Flu mRNA_Ph1_12 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
OG012
Control Ph1_YA Group
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
OG013
Flu mRNA_Ph2_1_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
OG014
Flu mRNA_Ph2_2_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1
OG015
Flu mRNA_Ph2_3_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
OG016
Control_Ph2_YA Group
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
OG017
Flu mRNA_Ph2_1_Older Adults (OA) Group
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
OG018
Flu mRNA_Ph2_2_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
OG019
Flu mRNA_Ph2_3_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
OG020
Control_Ph2_OA Group
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
Units
Counts
Participants
OG00019
OG00122
OG00222
OG00323
OG00421
OG00524
OG00623
OG00722
OG00819
OG00921
OG01022
OG01119
OG01222
OG013101
OG01497
OG015121
OG016115
OG017108
OG018116
OG019115
OG020111
Title
Denominators
Categories
Flu A1 Assay 1
ParticipantsOG00019
ParticipantsOG00122
ParticipantsOG00222
ParticipantsOG00323
ParticipantsOG00421
ParticipantsOG00524
ParticipantsOG00623
ParticipantsOG00722
ParticipantsOG00819
ParticipantsOG00921
ParticipantsOG01022
ParticipantsOG01119
ParticipantsOG01222
ParticipantsOG013101
ParticipantsOG01494
ParticipantsOG015119
ParticipantsOG016114
ParticipantsOG017107
ParticipantsOG018112
ParticipantsOG019113
ParticipantsOG020111
Title
Measurements
OG000469.49(300.51 to 733.47)
OG001335.19(222.96 to 503.91)
OG002247.82(164.81 to 372.65)
OG003
Flu A1 Assay 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Flu A2 Assay 1
ParticipantsOG00019
ParticipantsOG00122
ParticipantsOG00222
ParticipantsOG00323
Flu A2 Assay 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Flu B1 Assay 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Flu B1 Assay 2
ParticipantsOG00019
ParticipantsOG00122
ParticipantsOG00222
ParticipantsOG00323
Flu B2 Assay 1
ParticipantsOG00019
ParticipantsOG00122
ParticipantsOG00222
ParticipantsOG00323
Flu B2 Assay 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Flu mRNA_Ph1_4 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
OG004
Flu mRNA_Ph1_5 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
OG005
Flu mRNA_Ph1_6 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
OG006
Flu mRNA_Ph1_7 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
OG007
Flu mRNA_Ph1_8 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
OG008
Flu mRNA_Ph1_9 YA Group
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
OG009
Flu mRNA_Ph1_10 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
OG010
Flu mRNA_Ph1_11 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
OG011
Flu mRNA_Ph1_12 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
OG012
Control Ph1_YA Group
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
OG013
Flu mRNA_Ph2_1_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
OG014
Flu mRNA_Ph2_2_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1
OG015
Flu mRNA_Ph2_3_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
OG016
Control_Ph2_YA Group
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
OG017
Flu mRNA_Ph2_1_Older Adults (OA) Group
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
OG018
Flu mRNA_Ph2_2_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
OG019
Flu mRNA_Ph2_3_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
OG020
Control_Ph2_OA Group
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
Units
Counts
Participants
OG00019
OG00122
OG00222
OG00323
OG00421
OG00524
OG00623
OG00722
OG00819
OG00921
OG01022
OG01119
OG01222
OG013101
OG01497
OG015121
OG016115
OG017108
OG018116
OG019115
OG020111
Title
Denominators
Categories
Flu A1 Assay 1
ParticipantsOG00019
ParticipantsOG00122
ParticipantsOG00222
ParticipantsOG00323
ParticipantsOG00421
ParticipantsOG00524
ParticipantsOG00623
ParticipantsOG00722
ParticipantsOG00819
ParticipantsOG00921
ParticipantsOG01022
ParticipantsOG01119
ParticipantsOG01222
ParticipantsOG013101
ParticipantsOG01492
ParticipantsOG015119
ParticipantsOG016114
ParticipantsOG017107
ParticipantsOG018112
ParticipantsOG019113
ParticipantsOG020111
Title
Measurements
OG00012.83(8.21 to 20.04)
OG0019.16(6.09 to 13.77)
OG0026.77(4.50 to 10.18)
OG003
Flu A1 Assay 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Flu A2 Assay 1
ParticipantsOG00019
ParticipantsOG00122
ParticipantsOG00222
ParticipantsOG00323
Flu A2 Assay 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Flu B1 Assay 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Flu B1 Assay 2
ParticipantsOG00019
ParticipantsOG00122
ParticipantsOG00222
ParticipantsOG00323
Flu B2 Assay 1
ParticipantsOG00019
ParticipantsOG00122
ParticipantsOG00222
ParticipantsOG00323
Flu B2 Assay 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG003
Flu mRNA_Ph1_4 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
OG004
Flu mRNA_Ph1_5 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
OG005
Flu mRNA_Ph1_6 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
OG006
Flu mRNA_Ph1_7 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
OG007
Flu mRNA_Ph1_8 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
OG008
Flu mRNA_Ph1_9 YA Group
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
OG009
Flu mRNA_Ph1_10 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
OG010
Flu mRNA_Ph1_11 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
OG011
Flu mRNA_Ph1_12 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
OG012
Control Ph1_YA Group
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
OG013
Flu mRNA_Ph2_1_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
OG014
Flu mRNA_Ph2_2_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1
OG015
Flu mRNA_Ph2_3_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
OG016
Control_Ph2_YA Group
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
OG017
Flu mRNA_Ph2_1_Older Adults (OA) Group
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
OG018
Flu mRNA_Ph2_2_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
OG019
Flu mRNA_Ph2_3_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
OG020
Control_Ph2_OA Group
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
Units
Counts
Participants
OG00019
OG00122
OG00222
OG00323
OG00421
OG00524
OG00623
OG00722
OG00819
OG00921
OG01022
OG01119
OG01222
OG013101
OG01497
OG015121
OG016115
OG017108
OG018116
OG019115
OG020111
Title
Denominators
Categories
Flu A1 Assay 1
ParticipantsOG00019
ParticipantsOG00122
ParticipantsOG00222
ParticipantsOG00323
ParticipantsOG00421
ParticipantsOG00524
ParticipantsOG00623
ParticipantsOG00722
ParticipantsOG00819
ParticipantsOG00921
ParticipantsOG01022
ParticipantsOG01119
ParticipantsOG01222
ParticipantsOG013101
ParticipantsOG01494
ParticipantsOG015119
ParticipantsOG016114
ParticipantsOG017107
ParticipantsOG018112
ParticipantsOG019113
ParticipantsOG020111
Title
Measurements
OG00078.9(54.4 to 93.9)
OG00168.2(45.1 to 86.1)
OG00259.1(36.4 to 79.3)
OG003
Flu A1 Assay 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Flu A2 Assay 1
ParticipantsOG00019
ParticipantsOG00122
ParticipantsOG00222
ParticipantsOG00323
Flu A2 Assay 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Flu B1 Assay 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Flu B1 Assay 2
ParticipantsOG00019
ParticipantsOG00122
ParticipantsOG00222
ParticipantsOG00323
Flu B2 Assay 1
ParticipantsOG00019
ParticipantsOG00122
ParticipantsOG00222
ParticipantsOG00323
Flu B2 Assay 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Flu mRNA_Ph1_4 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
OG004
Flu mRNA_Ph1_5 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
OG005
Flu mRNA_Ph1_6 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
OG006
Flu mRNA_Ph1_7 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
OG007
Flu mRNA_Ph1_8 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
OG008
Flu mRNA_Ph1_9 YA Group
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
OG009
Flu mRNA_Ph1_10 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
OG010
Flu mRNA_Ph1_11 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
OG011
Flu mRNA_Ph1_12 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
OG012
Control Ph1_YA Group
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
OG013
Flu mRNA_Ph2_1_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
OG014
Flu mRNA_Ph2_2_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1
OG015
Flu mRNA_Ph2_3_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
OG016
Control_Ph2_YA Group
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
OG017
Flu mRNA_Ph2_1_Older Adults (OA) Group
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
OG018
Flu mRNA_Ph2_2_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
OG019
Flu mRNA_Ph2_3_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
OG020
Control_Ph2_OA Group
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
Units
Counts
Participants
OG00020
OG00122
OG00222
OG00323
OG00421
OG00524
OG00623
OG00722
OG00821
OG00921
OG01022
OG01121
OG01222
OG013102
OG01499
OG015125
OG016116
OG017110
OG018117
OG019119
OG020117
Title
Denominators
Categories
Flu A1 Assay 1
ParticipantsOG00020
ParticipantsOG00122
ParticipantsOG00222
ParticipantsOG00323
ParticipantsOG00421
ParticipantsOG00524
ParticipantsOG00623
ParticipantsOG00722
ParticipantsOG00821
ParticipantsOG00921
ParticipantsOG01022
ParticipantsOG01121
ParticipantsOG01222
ParticipantsOG013102
ParticipantsOG01496
ParticipantsOG015123
ParticipantsOG016115
ParticipantsOG017110
ParticipantsOG018114
ParticipantsOG019116
ParticipantsOG020117
Title
Measurements
OG00060.0(36.1 to 80.9)
OG00163.6(40.7 to 82.8)
OG00250.0(28.2 to 71.8)
OG003
Flu A1 Assay 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Flu A2 Assay 1
ParticipantsOG00020
ParticipantsOG00122
ParticipantsOG00222
ParticipantsOG00323
Flu A2 Assay 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Flu B1 Assay 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Flu B1 Assay 2
ParticipantsOG00020
ParticipantsOG00122
ParticipantsOG00222
ParticipantsOG00323
Flu B2 Assay 1
ParticipantsOG00020
ParticipantsOG00122
ParticipantsOG00222
ParticipantsOG00323
Flu B2 Assay 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
OG004
Flu mRNA_Ph1_5 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
OG005
Flu mRNA_Ph1_6 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
OG006
Flu mRNA_Ph1_7 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
OG007
Flu mRNA_Ph1_8 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
OG008
Flu mRNA_Ph1_9 YA Group
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
OG009
Flu mRNA_Ph1_10 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
OG010
Flu mRNA_Ph1_11 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
OG011
Flu mRNA_Ph1_12 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
OG012
Control Ph1_YA Group
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
OG013
Flu mRNA_Ph2_1_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
OG014
Flu mRNA_Ph2_2_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1
OG015
Flu mRNA_Ph2_3_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
OG016
Control_Ph2_YA Group
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
OG017
Flu mRNA_Ph2_1_Older Adults (OA) Group
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
OG018
Flu mRNA_Ph2_2_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
OG019
Flu mRNA_Ph2_3_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
OG020
Control_Ph2_OA Group
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
Units
Counts
Participants
OG00019
OG00122
OG00222
OG00323
OG00421
OG00524
OG00623
OG00722
OG00819
OG00921
OG01022
OG01119
OG01222
OG013101
OG01497
OG015121
OG016115
OG017108
OG018116
OG019115
OG020111
Title
Denominators
Categories
Flu A1 Assay 1
ParticipantsOG00019
ParticipantsOG00122
ParticipantsOG00222
ParticipantsOG00323
ParticipantsOG00421
ParticipantsOG00524
ParticipantsOG00623
ParticipantsOG00722
ParticipantsOG00819
ParticipantsOG00921
ParticipantsOG01022
ParticipantsOG01119
ParticipantsOG01222
ParticipantsOG013101
ParticipantsOG01496
ParticipantsOG015120
ParticipantsOG016115
ParticipantsOG017107
ParticipantsOG018112
ParticipantsOG019115
ParticipantsOG020111
Title
Measurements
OG00094.7(74.0 to 99.9)
OG001100(84.6 to 100)
OG00290.9(70.8 to 98.9)
OG003
Flu A1 Assay 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Flu A2 Assay 1
ParticipantsOG00019
ParticipantsOG00122
ParticipantsOG00222
ParticipantsOG00323
Flu A2 Assay 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Flu B1 Assay 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Flu B1 Assay 2
ParticipantsOG00019
ParticipantsOG00122
ParticipantsOG00222
ParticipantsOG00323
Flu B2 Assay 1
ParticipantsOG00019
ParticipantsOG00122
ParticipantsOG00222
ParticipantsOG00323
Flu B2 Assay 2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG004
Flu mRNA_Ph1_5 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
OG005
Flu mRNA_Ph1_6 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
OG006
Flu mRNA_Ph1_7 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
OG007
Flu mRNA_Ph1_8 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
OG008
Flu mRNA_Ph1_9 YA Group
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
OG009
Flu mRNA_Ph1_10 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
OG010
Flu mRNA_Ph1_11 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
OG011
Flu mRNA_Ph1_12 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
OG012
Control Ph1_YA Group
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
OG013
Flu mRNA_Ph2_1_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
OG014
Flu mRNA_Ph2_2_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1
OG015
Flu mRNA_Ph2_3_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
OG016
Control_Ph2_YA Group
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
OG017
Flu mRNA_Ph2_1_Older Adults (OA) Group
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
OG018
Flu mRNA_Ph2_2_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
OG019
Flu mRNA_Ph2_3_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
OG020
Control_Ph2_OA Group
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG00623
OG00722
OG00819
OG00921
OG01022
OG01119
OG01222
OG013101
OG01497
OG015121
OG016115
OG017108
OG018116
OG019115
OG020111
Title
Denominators
Categories
Flu A1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG00623
ParticipantsOG00722
ParticipantsOG00819
ParticipantsOG00921
ParticipantsOG01022
ParticipantsOG01119
ParticipantsOG01222
ParticipantsOG013101
ParticipantsOG01497
ParticipantsOG015121
ParticipantsOG016115
ParticipantsOG017108
ParticipantsOG018116
ParticipantsOG019115
ParticipantsOG020111
Title
Measurements
OG0065588.80(4242.15 to 7362.94)
OG0074087.84(3073.11 to 5437.63)
OG0084140.51(3070.75 to 5582.93)
OG009
Flu A2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Flu B1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Flu B2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG004
Flu mRNA_Ph1_5 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
OG005
Flu mRNA_Ph1_6 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
OG006
Flu mRNA_Ph1_7 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
OG007
Flu mRNA_Ph1_8 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
OG008
Flu mRNA_Ph1_9 YA Group
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
OG009
Flu mRNA_Ph1_10 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
OG010
Flu mRNA_Ph1_11 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
OG011
Flu mRNA_Ph1_12 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
OG012
Control Ph1_YA Group
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
OG013
Flu mRNA_Ph2_1_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
OG014
Flu mRNA_Ph2_2_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1
OG015
Flu mRNA_Ph2_3_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
OG016
Control_Ph2_YA Group
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
OG017
Flu mRNA_Ph2_1_Older Adults (OA) Group
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
OG018
Flu mRNA_Ph2_2_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
OG019
Flu mRNA_Ph2_3_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
OG020
Control_Ph2_OA Group
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG00623
OG00722
OG00819
OG00921
OG01022
OG01119
OG01222
OG013101
OG01497
OG015121
OG016115
OG017108
OG018116
OG019115
OG020111
Title
Denominators
Categories
Flu A1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG00623
ParticipantsOG00722
ParticipantsOG00819
ParticipantsOG00921
ParticipantsOG01022
ParticipantsOG01119
ParticipantsOG01222
ParticipantsOG013101
ParticipantsOG01497
ParticipantsOG015121
ParticipantsOG016115
ParticipantsOG017108
ParticipantsOG018116
ParticipantsOG019115
ParticipantsOG020111
Title
Measurements
OG0066.99(5.31 to 9.22)
OG0075.12(3.85 to 6.81)
OG0085.18(3.84 to 6.99)
OG009
Flu A2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Flu B1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Flu B2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG004
Flu mRNA_Ph1_5 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
OG005
Flu mRNA_Ph1_6 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
OG006
Flu mRNA_Ph1_7 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
OG007
Flu mRNA_Ph1_8 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
OG008
Flu mRNA_Ph1_9 YA Group
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
OG009
Flu mRNA_Ph1_10 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
OG010
Flu mRNA_Ph1_11 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
OG011
Flu mRNA_Ph1_12 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
OG012
Control Ph1_YA Group
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
OG013
Flu mRNA_Ph2_1_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
OG014
Flu mRNA_Ph2_2_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1
OG015
Flu mRNA_Ph2_3_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
OG016
Control_Ph2_YA Group
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
OG017
Flu mRNA_Ph2_1_Older Adults (OA) Group
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
OG018
Flu mRNA_Ph2_2_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
OG019
Flu mRNA_Ph2_3_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
OG020
Control_Ph2_OA Group
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG00623
OG00722
OG00819
OG00921
OG01022
OG01119
OG01222
OG013101
OG01497
OG015121
OG016115
OG017108
OG018116
OG019115
OG020111
Title
Denominators
Categories
Flu A1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG00623
ParticipantsOG00722
ParticipantsOG00819
ParticipantsOG00921
ParticipantsOG01022
ParticipantsOG01119
ParticipantsOG01222
ParticipantsOG013101
ParticipantsOG01497
ParticipantsOG015121
ParticipantsOG016115
ParticipantsOG017108
ParticipantsOG018116
ParticipantsOG019115
ParticipantsOG020111
Title
Measurements
OG00673.9(51.6 to 89.8)
OG00763.6(40.7 to 82.8)
OG00863.2(38.4 to 83.7)
OG009
Flu A2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Flu B1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Flu B2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG004
Flu mRNA_Ph1_5 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
OG005
Flu mRNA_Ph1_6 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
OG006
Flu mRNA_Ph1_7 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
OG007
Flu mRNA_Ph1_8 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
OG008
Flu mRNA_Ph1_9 YA Group
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
OG009
Flu mRNA_Ph1_10 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
OG010
Flu mRNA_Ph1_11 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
OG011
Flu mRNA_Ph1_12 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
OG012
Control Ph1_YA Group
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
OG013
Flu mRNA_Ph2_1_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
OG014
Flu mRNA_Ph2_2_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1
OG015
Flu mRNA_Ph2_3_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
OG016
Control_Ph2_YA Group
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
OG017
Flu mRNA_Ph2_1_Older Adults (OA) Group
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
OG018
Flu mRNA_Ph2_2_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
OG019
Flu mRNA_Ph2_3_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
OG020
Control_Ph2_OA Group
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
Units
Counts
Participants
OG00020
OG00122
OG00220
OG00321
OG00420
OG00520
OG00621
OG00720
OG00820
OG00920
OG01022
OG01121
OG01220
OG01396
OG01489
OG015117
OG016112
OG017105
OG018110
OG019111
OG020109
Title
Denominators
Categories
Flu A1 Assay 1
ParticipantsOG00020
ParticipantsOG00122
ParticipantsOG00220
ParticipantsOG00321
ParticipantsOG00420
ParticipantsOG00520
ParticipantsOG00621
ParticipantsOG00720
ParticipantsOG00820
ParticipantsOG00920
ParticipantsOG01022
ParticipantsOG01121
ParticipantsOG01220
ParticipantsOG01396
ParticipantsOG01486
ParticipantsOG015115
ParticipantsOG016111
ParticipantsOG017105
ParticipantsOG018107
ParticipantsOG019108
ParticipantsOG020109
Title
Measurements
OG000249.15(173.16 to 358.51)
OG001192.79(137.06 to 271.19)
OG002141.86(99.24 to 202.76)
OG003
Flu A2 Assay 1
ParticipantsOG00020
ParticipantsOG00122
ParticipantsOG00220
ParticipantsOG00321
Flu B1 Assay 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Flu B1 Assay 2
ParticipantsOG00020
ParticipantsOG00122
ParticipantsOG00220
ParticipantsOG00321
Flu B2 Assay 1
ParticipantsOG00020
ParticipantsOG00122
ParticipantsOG00220
ParticipantsOG00321
OG004
Flu mRNA_Ph1_5 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
OG005
Flu mRNA_Ph1_6 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
OG006
Flu mRNA_Ph1_7 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
OG007
Flu mRNA_Ph1_8 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
OG008
Flu mRNA_Ph1_9 YA Group
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
OG009
Flu mRNA_Ph1_10 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
OG010
Flu mRNA_Ph1_11 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
OG011
Flu mRNA_Ph1_12 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
OG012
Control Ph1_YA Group
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
OG013
Flu mRNA_Ph2_1_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
OG014
Flu mRNA_Ph2_2_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1
OG015
Flu mRNA_Ph2_3_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
OG016
Control_Ph2_YA Group
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
OG017
Flu mRNA_Ph2_1_Older Adults (OA) Group
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
OG018
Flu mRNA_Ph2_2_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
OG019
Flu mRNA_Ph2_3_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
OG020
Control_Ph2_OA Group
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
Units
Counts
Participants
OG00018
OG00115
OG00215
OG00320
OG00417
OG00516
OG00615
OG00715
OG00820
OG00917
OG01020
OG01118
OG01215
OG01396
OG01495
OG015120
OG016113
OG017103
OG018110
OG019112
OG020113
Title
Denominators
Categories
Flu A1 Assay 1
ParticipantsOG00017
ParticipantsOG00115
ParticipantsOG00215
ParticipantsOG00320
ParticipantsOG00417
ParticipantsOG00516
ParticipantsOG00615
ParticipantsOG00715
ParticipantsOG00820
ParticipantsOG00917
ParticipantsOG01020
ParticipantsOG01118
ParticipantsOG01215
ParticipantsOG01395
ParticipantsOG01492
ParticipantsOG015117
ParticipantsOG016112
ParticipantsOG017103
ParticipantsOG018108
ParticipantsOG019108
ParticipantsOG020113
Title
Measurements
OG000124.39(82.01 to 188.69)
OG001118.75(76.74 to 183.77)
OG002100.46(64.59 to 156.25)
OG003
Flu A2 Assay 1
ParticipantsOG00018
ParticipantsOG00115
ParticipantsOG00215
ParticipantsOG00320
Flu B1 Assay 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Flu B1 Assay 2
ParticipantsOG00018
ParticipantsOG00115
ParticipantsOG00215
ParticipantsOG00320
Flu B2 Assay 1
ParticipantsOG00018
ParticipantsOG00115
ParticipantsOG00215
ParticipantsOG00320
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
OG004
Flu mRNA_Ph1_5 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
OG005
Flu mRNA_Ph1_6 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
OG006
Flu mRNA_Ph1_7 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
OG007
Flu mRNA_Ph1_8 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
OG008
Flu mRNA_Ph1_9 YA Group
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
OG009
Flu mRNA_Ph1_10 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
OG010
Flu mRNA_Ph1_11 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
OG011
Flu mRNA_Ph1_12 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
OG012
Control Ph1_YA Group
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
OG013
Flu mRNA_Ph2_1_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
OG014
Flu mRNA_Ph2_2_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1
OG015
Flu mRNA_Ph2_3_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
OG016
Control_Ph2_YA Group
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
OG017
Flu mRNA_Ph2_1_Older Adults (OA) Group
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
OG018
Flu mRNA_Ph2_2_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
OG019
Flu mRNA_Ph2_3_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
OG020
Control_Ph2_OA Group
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
Units
Counts
Participants
OG00020
OG00122
OG00220
OG00321
OG00420
OG00520
OG00621
OG00720
OG00820
OG00920
OG01022
OG01121
OG01220
OG01396
OG01489
OG015117
OG016112
OG017105
OG018110
OG019111
OG020109
Title
Denominators
Categories
Flu A1 Assay 1
ParticipantsOG00020
ParticipantsOG00122
ParticipantsOG00220
ParticipantsOG00321
ParticipantsOG00420
ParticipantsOG00520
ParticipantsOG00621
ParticipantsOG00720
ParticipantsOG00820
ParticipantsOG00920
ParticipantsOG01022
ParticipantsOG01121
ParticipantsOG01220
ParticipantsOG01396
ParticipantsOG01486
ParticipantsOG015115
ParticipantsOG016111
ParticipantsOG017105
ParticipantsOG018107
ParticipantsOG019108
ParticipantsOG020109
Title
Measurements
OG0006.95(4.83 to 10.00)
OG0015.38(3.82 to 7.56)
OG0023.96(2.77 to 5.66)
OG003
Flu A2 Assay 1
ParticipantsOG00020
ParticipantsOG00122
ParticipantsOG00220
ParticipantsOG00321
Flu B1 Assay 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Flu B1 Assay 2
ParticipantsOG00020
ParticipantsOG00122
ParticipantsOG00220
ParticipantsOG00321
Flu B2 Assay 1
ParticipantsOG00020
ParticipantsOG00122
ParticipantsOG00220
ParticipantsOG00321
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
OG004
Flu mRNA_Ph1_5 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
OG005
Flu mRNA_Ph1_6 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
OG006
Flu mRNA_Ph1_7 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
OG007
Flu mRNA_Ph1_8 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
OG008
Flu mRNA_Ph1_9 YA Group
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
OG009
Flu mRNA_Ph1_10 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
OG010
Flu mRNA_Ph1_11 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
OG011
Flu mRNA_Ph1_12 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
OG012
Control Ph1_YA Group
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
OG013
Flu mRNA_Ph2_1_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
OG014
Flu mRNA_Ph2_2_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1
OG015
Flu mRNA_Ph2_3_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
OG016
Control_Ph2_YA Group
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
OG017
Flu mRNA_Ph2_1_Older Adults (OA) Group
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
OG018
Flu mRNA_Ph2_2_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
OG019
Flu mRNA_Ph2_3_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
OG020
Control_Ph2_OA Group
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
Units
Counts
Participants
OG00018
OG00115
OG00215
OG00320
OG00417
OG00516
OG00615
OG00715
OG00820
OG00917
OG01020
OG01118
OG01215
OG01396
OG01495
OG015120
OG016113
OG017103
OG018110
OG019112
OG020113
Title
Denominators
Categories
Flu A1 Assay 1
ParticipantsOG00017
ParticipantsOG00115
ParticipantsOG00215
ParticipantsOG00320
ParticipantsOG00417
ParticipantsOG00516
ParticipantsOG00615
ParticipantsOG00715
ParticipantsOG00820
ParticipantsOG00917
ParticipantsOG01020
ParticipantsOG01118
ParticipantsOG01215
ParticipantsOG01395
ParticipantsOG01492
ParticipantsOG015117
ParticipantsOG016112
ParticipantsOG017103
ParticipantsOG018108
ParticipantsOG019108
ParticipantsOG020113
Title
Measurements
OG0003.55(2.34 to 5.39)
OG0013.39(2.19 to 5.25)
OG0022.87(1.84 to 4.46)
OG003
Flu A2 Assay 1
ParticipantsOG00018
ParticipantsOG00115
ParticipantsOG00215
ParticipantsOG00320
Flu B1 Assay 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Flu B1 Assay 2
ParticipantsOG00018
ParticipantsOG00115
ParticipantsOG00215
ParticipantsOG00320
Flu B2 Assay 1
ParticipantsOG00018
ParticipantsOG00115
ParticipantsOG00215
ParticipantsOG00320
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
OG004
Flu mRNA_Ph1_5 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
OG005
Flu mRNA_Ph1_6 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
OG006
Flu mRNA_Ph1_7 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
OG007
Flu mRNA_Ph1_8 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
OG008
Flu mRNA_Ph1_9 YA Group
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
OG009
Flu mRNA_Ph1_10 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
OG010
Flu mRNA_Ph1_11 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
OG011
Flu mRNA_Ph1_12 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
OG012
Control Ph1_YA Group
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
OG013
Flu mRNA_Ph2_1_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
OG014
Flu mRNA_Ph2_2_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1
OG015
Flu mRNA_Ph2_3_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
OG016
Control_Ph2_YA Group
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
OG017
Flu mRNA_Ph2_1_Older Adults (OA) Group
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
OG018
Flu mRNA_Ph2_2_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
OG019
Flu mRNA_Ph2_3_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
OG020
Control_Ph2_OA Group
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
Units
Counts
Participants
OG00018
OG00115
OG00215
OG00320
OG00417
OG00516
OG00615
OG00715
OG00820
OG00917
OG01020
OG01118
OG01215
OG01396
OG01495
OG015120
OG016113
OG017103
OG018110
OG019112
OG020113
Title
Denominators
Categories
Flu A1 Assay 1
ParticipantsOG00017
ParticipantsOG00115
ParticipantsOG00215
ParticipantsOG00320
ParticipantsOG00417
ParticipantsOG00516
ParticipantsOG00615
ParticipantsOG00715
ParticipantsOG00820
ParticipantsOG00917
ParticipantsOG01020
ParticipantsOG01118
ParticipantsOG01215
ParticipantsOG01395
ParticipantsOG01495
ParticipantsOG015118
ParticipantsOG016113
ParticipantsOG017103
ParticipantsOG018108
ParticipantsOG019110
ParticipantsOG020113
Title
Measurements
OG00094.1(71.3 to 99.9)
OG00193.3(68.1 to 99.8)
OG00286.7(59.5 to 98.3)
OG003
Flu A2 Assay 1
ParticipantsOG00018
ParticipantsOG00115
ParticipantsOG00215
ParticipantsOG00320
Flu B1 Assay 1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Flu B1 Assay 2
ParticipantsOG00018
ParticipantsOG00115
ParticipantsOG00215
ParticipantsOG00320
Flu B2 Assay 1
ParticipantsOG00018
ParticipantsOG00115
ParticipantsOG00215
ParticipantsOG00320
OG004
Flu mRNA_Ph1_5 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
OG005
Flu mRNA_Ph1_6 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
OG006
Flu mRNA_Ph1_7 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
OG007
Flu mRNA_Ph1_8 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
OG008
Flu mRNA_Ph1_9 YA Group
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
OG009
Flu mRNA_Ph1_10 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
OG010
Flu mRNA_Ph1_11 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
OG011
Flu mRNA_Ph1_12 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
OG012
Control Ph1_YA Group
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
OG013
Flu mRNA_Ph2_1_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
OG014
Flu mRNA_Ph2_2_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1
OG015
Flu mRNA_Ph2_3_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
OG016
Control_Ph2_YA Group
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
OG017
Flu mRNA_Ph2_1_Older Adults (OA) Group
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
OG018
Flu mRNA_Ph2_2_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
OG019
Flu mRNA_Ph2_3_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
OG020
Control_Ph2_OA Group
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG00621
OG00720
OG00820
OG00920
OG01022
OG01121
OG01220
OG01396
OG01495
OG015120
OG016113
OG017105
OG018110
OG019112
OG020113
Title
Denominators
Categories
Flu A1, Post-dosing at Day 92
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG00621
ParticipantsOG00720
ParticipantsOG00820
ParticipantsOG00920
ParticipantsOG01022
ParticipantsOG01121
ParticipantsOG01220
ParticipantsOG01396
ParticipantsOG01489
ParticipantsOG015117
ParticipantsOG016112
ParticipantsOG017105
ParticipantsOG018110
ParticipantsOG019111
ParticipantsOG020108
Title
Measurements
OG0063413.56(2608.88 to 4466.45)
OG0073012.57(2280.43 to 3979.78)
OG0082965.07(2254.80 to 3899.08)
OG009
Flu A1, Post-dosing at Day 183
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Flu A2, Post-dosing at Day 92
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Flu A2, Post-dosing at Day 183
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Flu B1, Post-dosing at Day 92
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Flu B1, Post-dosing at Day 183
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Flu B2, Post-dosing at Day 92
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Flu B2, Post-dosing at Day 183
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG004
Flu mRNA_Ph1_5 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
OG005
Flu mRNA_Ph1_6 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
OG006
Flu mRNA_Ph1_7 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
OG007
Flu mRNA_Ph1_8 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
OG008
Flu mRNA_Ph1_9 YA Group
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
OG009
Flu mRNA_Ph1_10 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
OG010
Flu mRNA_Ph1_11 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
OG011
Flu mRNA_Ph1_12 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
OG012
Control Ph1_YA Group
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
OG013
Flu mRNA_Ph2_1_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
OG014
Flu mRNA_Ph2_2_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1
OG015
Flu mRNA_Ph2_3_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
OG016
Control_Ph2_YA Group
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
OG017
Flu mRNA_Ph2_1_Older Adults (OA) Group
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
OG018
Flu mRNA_Ph2_2_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
OG019
Flu mRNA_Ph2_3_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
OG020
Control_Ph2_OA Group
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.