A Study to Find the Dose and Assess the Immune Response a... | NCT06431607 | Trialant
NCT06431607
Sponsor
GlaxoSmithKline
Status
Completed
Last Update Posted
Mar 10, 2026Actual
Enrollment
845Actual
Phase
Phase 2
Conditions
Influenza, Human
Interventions
F2G22B/DL001Z
F2H23D/DL001Z-NH
F2H23B/DL001Z-NH
F2H23H/DL001Z
FDQ23A-NH (Flu D-QIV)
GSK5800544A
Flu D-TIV
F2H23A/DL001Z-NH
F2H23G/DL001Z
Fluzone HD Quadrivalent
Fluzone HD
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT06431607
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
222853
Secondary IDs
Not provided
Brief Title
A Study to Find the Dose and Assess the Immune Response and Safety of a Vaccine Against Influenza in Healthy Younger and Older Adults
Official Title
A Phase 2a Randomized, Observer-blind, Dose-finding Study to Evaluate the Immunogenicity and Safety of mRNA-based Multivalent Seasonal Influenza Vaccine Candidates in Adults 18 Years of Age and Older
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Feb 2026
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
May 23, 2024Actual
Primary Completion Date
Dec 27, 2024Actual
Completion Date
Jun 4, 2025Actual
First Submitted Date
May 22, 2024
First Submission Date that Met QC Criteria
May 22, 2024
First Posted Date
May 28, 2024Actual
Results Waived
Not provided
Results First Submitted Date
Dec 22, 2025
Results First Submitted that Met QC Criteria
Feb 17, 2026
Results First Posted Date
Mar 10, 2026Actual
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
Feb 17, 2026
Last Update Posted Date
Mar 10, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
Collaborators
Not provided
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 assess the safety and immune response of GlaxoSmithKlines (GSK) messenger RNA (mRNA)-based multivalent vaccine (GSK4382276A) candidate against influenza, administered in healthy younger adults (YA) 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 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
845Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part 1 YA: Flu mRNA_1_Younger Adults (YA)
Experimental
YA participants received a single dose of Flu mRNA study intervention F2G22B/DL001Z administered at Day 1.
Biological: F2G22B/DL001Z
Part 1 YA: Flu mRNA_2_YA
Experimental
YA participants received a single dose of Flu mRNA study intervention F2H23D/DL001Z-NH administered at Day 1.
Biological: F2H23D/DL001Z-NH
Part 1 YA: Flu mRNA_3_YA
Experimental
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
Biological: F2H23B/DL001Z-NH
Part 1 YA: Flu mRNA_4_YA
Experimental
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
Biological: F2H23H/DL001Z
Part 1 YA: Comparator_1_YA
Active Comparator
YA participants received a single dose of Comparator 1 [FDQ23A-NH (Flu D-QIV)] administered at Day 1.
Combination Product: FDQ23A-NH (Flu D-QIV)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
F2G22B/DL001Z
Biological
Study intervention was administered intramuscularly at Day 1.
Part 1 YA: Flu mRNA_1_Younger Adults (YA)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part 1 YA: 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
Part 2 YA: GMT of Antigen 1 Antibody Titer
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
At Day 29
Part 1 OA: GMT of Antigen 1 Antibody Titer
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
At Day 29
Part 2 OA: GMT of Antigen 1 Antibody Titer
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
At Day 29
Part 1 YA: Geometric Mean Increase (GMI) of Antigen 1 Antibody Titers
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
Part 2 YA: GMI of Antigen 1 Antibody Titers
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
Part 1 OA: GMI of Antigen 1 Antibody Titers
Secondary Outcomes
Measure
Description
Time Frame
Part 1 YA: GMT of Antigen 2 Antibody Titer
At Day 29
Part 2 YA: GMT of Antigen 2 Antibody Titer
At Day 29
Part 1 OA: GMT of Antigen 2 Antibody Titer
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
A male or female between and including 18 and 85 years of age (YAs: 18-64; OAs: 65-85) at the time of the study intervention administration.
Healthy participants or medically stable patients as established by medical history and clinical examination. Participants with chronic medical conditions with or without specific treatment (e.g., chronic metabolic, cardiac, pulmonary, renal, hepatic, neurologic, and hematologic diseases) 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 enrolment.
Body mass index (BMI) >=18 Kilograms per meter square (kg/m²) and less than or equal to (<=) 35kg/m2.
Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits), independently or with the assistance of a caregiver.
Written informed consent obtained from the participant prior to performance of any study-specific procedure.
Female participants of non-childbearing potential may be enrolled in the clinical study.
Female participants of childbearing potential may be enrolled in the clinical study, if the participant:
Has practiced adequate contraception for 1 month prior to the study intervention administration, and
Has a negative pregnancy test within 24 hours prior to the study intervention administration, and
Has agreed to continue adequate contraception for at least 1 month after study intervention administration.
Exclusion Criteria:
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 sequelae for greater than (>) 5 years before the study intervention administration (excluding effectively treated basal cell skin cancer).
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required). HIV-infected individuals may be enrolled if they 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 (mm³) and their viral load has been undetectable (i.e., HIV-RNA lesser than (<) 50 copies/milliliter [mL]) (based on medical records, no laboratory testing required).
Participants with a history of, or current suspicion of myocarditis, pericarditis, or idiopathic cardiomyopathy (including a history of myocarditis or pericarditis following vaccination with an mRNA COVID-19 vaccine), or presence of any medical condition that increases risk of myocarditis or pericarditis, including cocaine abuse, cardiomyopathy, endomyocardial fibrosis, hypereosinophilic syndrome, hypersensitivity myocarditis, eosinophilic granulomatosis with polyangiitis and persistent myocardial infection will be excluded from the study.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention (including polyethylene glycol, egg proteins and aminoglycoside antibiotics).
Any history of dementia or any medical condition that moderately or severely impairs cognition.
Any 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 clinical study.
Administration of an influenza vaccine within 180 days before enrollment or planned administration prior to Visit 2 (Day 29) after the study intervention administration.
Previous vaccination with a mRNA influenza vaccine.
Administration of a vaccine not foreseen by the study protocol in the period starting 30 days (Day -30) before the study intervention administration, or planned administration within 28 days (Visit 2 [Day 29]) after the study intervention administration*.
If emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is recommended and/or organized by public health authorities outside the routine immunization program, the time period described above can be reduced, provided it is used according to the local governmental recommendations and sponsor is notified.
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 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.
Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune-modifying treatments at any time up to the end of the study.
Up to 3 months prior to the study intervention administration:
For corticosteroids, this will mean prednisone equivalent >=20 mg/day. Inhaled, intraarticular and topical steroids are allowed.
Up to 3 months prior to study intervention administration: long-acting immune-modifying drugs including among others immunotherapy (e.g., TNF-inhibitors), monoclonal antibodies, antitumoral medication.
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 participant.
Bedridden participants.
Female participant planning to become pregnant or planning to discontinue contraceptive precautions within the 1-month post-dosing period.
History of chronic alcohol consumption and/or drug abuse in the past 5 years as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures.
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
Not provided
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 GSK5800544A administered at Day 1.
Biological: GSK5800544A
Part 2 YA: Comparator_2_YA
Active Comparator
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
Combination Product: Flu D-TIV
Part 1 OA: Flu mRNA_5_Older Adults (OA)
Experimental
OA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
Biological: F2H23B/DL001Z-NH
Part 1 OA: Flu mRNA_6_OA
Experimental
OA participants received a single dose of Flu mRNA study intervention F2H23A/DL001Z-NH administered at Day 1.
Biological: F2H23A/DL001Z-NH
Part 1 OA: Flu mRNA_7_OA
Experimental
OA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
Biological: F2H23H/DL001Z
Part 1 OA: Flu mRNA_8_OA
Experimental
OA participants received a single dose of Flu mRNA study intervention F2H23G/DL001Z administered at Day 1.
Biological: F2H23G/DL001Z
Part 1 OA: Comparator_1_OA
Active Comparator
OA participants received a single dose of Comparator 1 (Fluzone HD Quadrivalent) administered at Day 1.
Combination Product: Fluzone HD Quadrivalent
Part 2 OA: Flu mRNA_10_OA
Experimental
OA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
Biological: GSK5800544A
Part 2 OA: Comparator_2_OA
Active Comparator
OA participants received a single dose of Comparator 2 (Fluzone HD) administered at Day 1.
Combination Product: Fluzone HD
F2H23D/DL001Z-NH
Biological
Study intervention was administered intramuscularly at Day 1.
Part 1 YA: Flu mRNA_2_YA
F2H23B/DL001Z-NH
Biological
Study intervention was administered intramuscularly at Day 1.
Part 1 OA: Flu mRNA_5_Older Adults (OA)
Part 1 YA: Flu mRNA_3_YA
F2H23H/DL001Z
Biological
Study intervention was administered intramuscularly at Day 1.
Part 1 OA: Flu mRNA_7_OA
Part 1 YA: Flu mRNA_4_YA
FDQ23A-NH (Flu D-QIV)
Combination Product
Control Vaccine was administered intramuscularly at Day 1.
Part 1 YA: Comparator_1_YA
GSK5800544A
Biological
Study intervention was administered intramuscularly at Day 1.
Part 2 OA: Flu mRNA_10_OA
Part 2 YA: Flu mRNA_9_YA
Flu D-TIV
Combination Product
Control Vaccine was administered intramuscularly at Day 1.
Part 2 YA: Comparator_2_YA
F2H23A/DL001Z-NH
Biological
Study intervention was administered intramuscularly at Day 1.
Part 1 OA: Flu mRNA_6_OA
F2H23G/DL001Z
Biological
Study intervention was administered intramuscularly at Day 1.
Part 1 OA: Flu mRNA_8_OA
Fluzone HD Quadrivalent
Combination Product
Control vaccine was administered intramuscularly at Day 1.
Part 1 OA: Comparator_1_OA
Fluzone HD
Combination Product
Control vaccine was administered intramuscularly at Day 1.
Part 2 OA: Comparator_2_OA
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
Part 2 OA: GMI of Antigen 1 Antibody Titers
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
Part 1 YA: 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 (baseline) to Day 29
Part 2 YA: Percentage of Participants With Antigen 1 Antibody 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 (baseline) to Day 29
Part 1 OA: Percentage of Participants With Antigen 1 Antibody 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 (baseline) to Day 29
Part 2 OA: Percentage of Participants With Antigen 1 Antibody 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 (baseline) to Day 29
Part 1 YA: 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
Part 2 YA: Percentage of Participants With Antigen 1 Antibody 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
Part 1 OA: Percentage of Participants With Antigen 1 Antibody 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
Part 2 OA: Percentage of Participants With Antigen 1 Antibody 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
Part 1 YA: Percentage of Participants With Antigen 1 Antibody 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 29
Part 2 YA: Percentage of Participants With Antigen 1 Antibody 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 29
Part 1 OA: Percentage of Participants With Antigen 1 Antibody 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 29
Part 2 OA: Percentage of Participants With Antigen 1 Antibody 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 29
At Day 29
Part 2 OA: GMT of Antigen 2 Antibody Titer
At Day 29
Part 1 YA: GMI of Antigen 2 Antibody Titer
From Day 1 (baseline) to Day 29
Part 2 YA: GMI of Antigen 2 Antibody Titer
From Day 1 (baseline) to Day 29
Part 1 OA: GMI of Antigen 2 Antibody Titer
From Day 1 (baseline) to Day 29
Part 2 OA: GMI of Antigen 2 Antibody Titer
From Day 1 (baseline) to Day 29
Part 1 YA: Percentage of Participants With Antigen 2 Antibody SCR
From Day 1 (baseline) to Day 29
Part 2 YA: Percentage of Participants With Antigen 2 Antibody SCR
From Day 1 (baseline) to Day 29
Part 1 OA: Percentage of Participants With Antigen 2 Antibody SCR
From Day 1 (baseline) to Day 29
Part 2 OA: Percentage of Participants With Antigen 2 Antibody SCR
From Day 1 (baseline) to Day 29
Part 1 YA: 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.
Day 1 to Day 7
Part 2 YA: Number of Participants Reporting Any Solicited Administration Site 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.
Day 1 to Day 7
Part 1 OA: Number of Participants Reporting Any Solicited Administration Site 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.
Day 1 to Day 7
Part 2 OA: Number of Participants Reporting Any Solicited Administration Site 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.
Day 1 to Day 7
Part 1 YA: Number of Participants Reporting Any Solicited Systemic AEs
Assessed solicited systemic events included fever (pyrexia) which is defined as axillary temperature greater than or equal to (>=) 38.0°C/100.4°F, chills, headache, fatigue (tiredness), myalgia (muscle joint), and arthralgia (joint pain). Any = occurrence of the event regardless of intensity grade.
Day 1 to Day 7
Part 2 YA: Number of Participants Reporting Any Solicited Systemic AEs
Assessed solicited systemic events included fever (pyrexia) which is defined as axillary temperature >= 38.0°C/100.4°F, chills, headache, fatigue (tiredness), myalgia (muscle joint), and arthralgia (joint pain). Any = occurrence of the event regardless of intensity grade.
Day 1 to Day 7
Part 1 OA: Number of Participants Reporting Any Solicited Systemic AEs
Assessed solicited systemic events included fever (pyrexia) which is defined as axillary temperature >= 38.0°C/100.4°F, chills, headache, fatigue (tiredness), myalgia (muscle joint), and arthralgia (joint pain). Any = occurrence of the event regardless of intensity grade.
Day 1 to Day 7
Part 2 OA: Number of Participants Reporting Any Solicited Systemic AEs
Assessed solicited systemic events included fever (pyrexia) which is defined as axillary temperature >= 38.0°C/100.4°F, chills, headache, fatigue (tiredness), myalgia (muscle joint), and arthralgia (joint pain). Any = occurrence of the event regardless of intensity grade.
Day 1 to Day 7
Part 1 YA: 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.
Day 1 to Day 28
Part 2 YA: 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.
Day 1 to Day 28
Part 1 OA: 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.
Day 1 to Day 28
Part 2 OA: 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.
Day 1 to Day 28
Part 1 YA: 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.
Day 1 to Day 183
Part 2 YA: Number of Participants Reporting 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.
Day 1 to Day 183
Part 1 OA: Number of Participants Reporting 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.
Day 1 to Day 183
Part 2 OA: Number of Participants Reporting 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.
Day 1 to Day 183
Part 1 YA: 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.
Day 1 to Day 183
Part 2 YA: Number of Participants Reporting 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.
Day 1 to Day 183
Part 1 OA: Number of Participants Reporting 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.
Day 1 to Day 183
Part 2 OA: Number of Participants Reporting 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.
Day 1 to Day 183
Part 1 YA: Number of Participants Reporting Medically Attended Adverse Events (MAAEs)
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.
Day 1 to Day 183
Part 2 YA: Number of Participants Reporting MAAEs
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.
Day 1 to Day 183
Part 1 OA: Number of Participants Reporting MAAEs
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.
Day 1 to Day 183
Part 2 OA: Number of Participants Reporting MAAEs
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.
Day 1 to Day 183
Miami
Florida
33147
United States
GSK Investigational Site
Miami
Florida
33186
United States
GSK Investigational Site
Chicago
Illinois
60640
United States
GSK Investigational Site
Valparaiso
Indiana
46383
United States
GSK Investigational Site
El Dorado
Kansas
67042
United States
GSK Investigational Site
Lenexa
Kansas
66219
United States
GSK Investigational Site
Newton
Kansas
67114
United States
GSK Investigational Site
Wichita
Kansas
67207
United States
GSK Investigational Site
Lexington
Kentucky
40509
United States
GSK Investigational Site
Rochester
New York
14609
United States
GSK Investigational Site
Greensboro
North Carolina
27408
United States
GSK Investigational Site
Knoxville
Tennessee
37909
United States
GSK Investigational Site
Austin
Texas
78705
United States
GSK Investigational Site
Fort Worth
Texas
76135
United States
GSK Investigational Site
Tomball
Texas
77375
United States
GSK Investigational Site
Newport News
Virginia
23606
United States
GSK Investigational Site
Norfolk
Virginia
23502
United States
YA participants received a single dose of Flu mRNA study intervention F2H23D/DL001Z-NH administered at Day 1.
FG002
Part 1 YA: Flu mRNA_3_YA
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
FG003
Part 1 YA: Flu mRNA_4_YA
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
FG004
Part 1 YA: Comparator_1_YA
YA participants received a single dose of Comparator 1 ([FDQ23A-NH (Flu D-QIV)] administered at Day 1.
FG005
Part 2 YA: Flu mRNA_9_YA
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
FG006
Part 2 YA: Comparator_2_YA
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
FG007
Part 1 OA: Flu mRNA_5_Older Adults (OA)
OA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
FG008
Part 1 OA: Flu mRNA_6_OA
OA participants received a single dose of Flu mRNA study intervention F2H23A/DL001Z-NH administered at Day 1.
FG009
Part 1 OA: Flu mRNA_7_OA
OA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
FG010
Part 1 OA: Flu mRNA_8_OA
OA participants received a single dose of Flu mRNA study intervention F2H23G/DL001Z administered at Day 1.
FG011
Part 1 OA: Comparator_1_OA
OA participants received a single dose of Comparator 1 (Fluzone HD Quadrivalent) administered at Day 1.
FG012
Part 2 OA: Flu mRNA_10_OA
OA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
FG013
Part 2 OA: Comparator_2_OA
OA participants received a single dose of Comparator 2 (Fluzone HD) administered at Day 1.
FG00050 subjects
FG00150 subjects
FG00248 subjects
FG00350 subjects
FG00452 subjects
FG00581 subjects
FG00680 subjects
FG00751 subjects
FG00852 subjects
FG00953 subjects
FG01051 subjects
FG01153 subjects
FG01282 subjects
FG01380 subjects
COMPLETED
FG00049 subjects
FG00149 subjects
FG00247 subjects
FG00350 subjects
FG00447 subjects
FG00577 subjects
FG00677 subjects
FG00751 subjects
FG00852 subjects
FG00953 subjects
FG01050 subjects
FG01153 subjects
FG01281 subjects
FG01378 subjects
NOT COMPLETED
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG0045 subjects
FG0054 subjects
FG0063 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0101 subjects
FG0110 subjects
FG0121 subjects
FG0132 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0045 subjects
FG0054 subjects
FG0063 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0121 subjects
FG0131 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1 YA: Flu mRNA_1_Younger Adults (YA)
YA participants received a single dose of Flu mRNA study intervention F2G22B/DL001Z administered at Day 1.
BG001
Part 1 YA: Flu mRNA_2_YA
YA participants received a single dose of Flu mRNA study intervention F2H23D/DL001Z-NH administered at Day 1.
BG002
Part 1 YA: Flu mRNA_3_YA
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
BG003
Part 1 YA: Flu mRNA_4_YA
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
BG004
Part 1 YA: Comparator_1_YA
YA participants received a single dose of Comparator 1 ([FDQ23A-NH (Flu D-QIV)] administered at Day 1.
BG005
Part 2 YA: Flu mRNA_9_YA
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
BG006
Part 2 YA: Comparator_2_YA
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
BG007
Part 1 OA: Flu mRNA_5_Older Adults (OA)
OA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
BG008
Part 1 OA: Flu mRNA_6_OA
OA participants received a single dose of Flu mRNA study intervention F2H23A/DL001Z-NH administered at Day 1.
BG009
Part 1 OA: Flu mRNA_7_OA
OA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
BG010
Part 1 OA: Flu mRNA_8_OA
OA participants received a single dose of Flu mRNA study intervention F2H23G/DL001Z administered at Day 1.
BG011
Part 1 OA: Comparator_1_OA
OA participants received a single dose of Comparator 1 (Fluzone HD Quadrivalent) administered at Day 1.
BG012
Part 2 OA: Flu mRNA_10_OA
OA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
BG013
Part 2 OA: Comparator_2_OA
OA participants received a single dose of Comparator 2 (Fluzone HD) administered at Day 1.
BG014
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00050
BG00150
BG00248
BG00350
BG00452
BG00581
BG00680
BG00751
BG00852
BG00953
BG01051
BG01153
BG01282
BG01380
BG014833
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
BG00050
BG00150
BG00248
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00029
BG00126
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
American Indian or Alaska Native
Title
Measurements
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Part 1 YA: 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 immunogenicity results at Day 29 , without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination before Day 29. Only participants with data available for specified analysis at the specified timepoints are included.
Posted
Geometric Mean
95% Confidence Interval
Titers
At Day 29
ID
Title
Description
OG000
Part 1 YA: Flu mRNA_1_Younger Adults (YA)
YA participants received a single dose of Flu mRNA study intervention F2G22B/DL001Z administered at Day 1.
OG001
Part 1 YA: Flu mRNA_2_YA
YA participants received a single dose of Flu mRNA study intervention F2H23D/DL001Z-NH administered at Day 1.
OG002
Part 1 YA: Flu mRNA_3_YA
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
OG003
Part 1 YA: Flu mRNA_4_YA
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
OG004
Part 1 YA: Comparator_1_YA
YA participants received a single dose of Comparator 1 ([FDQ23A-NH (Flu D-QIV)] administered at Day 1.
Units
Counts
Participants
OG00046
OG00144
OG00243
OG003
Title
Denominators
Categories
Flu A1 Assay 1
ParticipantsOG00045
ParticipantsOG00144
ParticipantsOG00243
ParticipantsOG003
Primary
Part 2 YA: 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 specified analysis at the specified timepoints were included.
Posted
Geometric Mean
95% Confidence Interval
Titers
At Day 29
ID
Title
Description
OG000
Part 2 YA: Flu mRNA_9_YA
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
OG001
Part 2 YA: Comparator_2_YA
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
Units
Counts
Participants
OG000
Primary
Part 1 OA: 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 specified analysis at the specified timepoints were included.
Posted
Geometric Mean
95% Confidence Interval
Titers
At Day 29
ID
Title
Description
OG000
Part 1 OA: Flu mRNA_5_Older Adults (OA)
OA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
OG001
Part 1 OA: Flu mRNA_6_OA
OA participants received a single dose of Flu mRNA study intervention F2H23A/DL001Z-NH administered at Day 1.
OG002
Part 1 OA: Flu mRNA_7_OA
OA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
OG003
Part 1 OA: Flu mRNA_8_OA
OA participants received a single dose of Flu mRNA study intervention F2H23G/DL001Z administered at Day 1.
Primary
Part 2 OA: 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 specified analysis at the specified timepoints were included.
Posted
Geometric Mean
95% Confidence Interval
Titers
At Day 29
ID
Title
Description
OG000
Part 2 OA: Flu mRNA_10_OA
OA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
OG001
Part 2 OA: Comparator_2_OA
OA participants received a single dose of Comparator 2 administered at Day 1.
Units
Counts
Participants
OG000
Primary
Part 1 YA: Geometric Mean Increase (GMI) of Antigen 1 Antibody Titers
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 Per Protocol Set (PPS), which included all eligible participants who received the study intervention dose according to the protocol, had immunogenicity results at both Day 1 and Day 29 , without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination beforeDay 29 and for whom data were available for the specified analysis at the specified timepoints.
Posted
Geometric Mean
95% Confidence Interval
Ratio
From Day 1 (baseline) to Day 29
ID
Title
Description
OG000
Part 1 YA: Flu mRNA_1_Younger Adults (YA)
YA participants received a single dose of Flu mRNA study intervention F2G22B/DL001Z administered at Day 1.
OG001
Part 1 YA: Flu mRNA_2_YA
YA participants received a single dose of Flu mRNA study intervention F2H23D/DL001Z-NH administered at Day 1.
OG002
Part 1 YA: Flu mRNA_3_YA
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
Primary
Part 2 YA: GMI of Antigen 1 Antibody Titers
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 duration were included.
Posted
Geometric Mean
95% Confidence Interval
Ratio
From Day 1 (baseline) to Day 29
ID
Title
Description
OG000
Part 2 YA: Flu mRNA_9_YA
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
OG001
Part 2 YA: Comparator_2_YA
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
Units
Counts
Participants
OG000
Primary
Part 1 OA: GMI of Antigen 1 Antibody Titers
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 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
Part 1 OA: Flu mRNA_5_Older Adults (OA)
OA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
OG001
Part 1 OA: Flu mRNA_6_OA
OA participants received a single dose of Flu mRNA study intervention F2H23A/DL001Z-NH administered at Day 1.
OG002
Part 1 OA: Flu mRNA_7_OA
OA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
OG003
Part 1 OA: Flu mRNA_8_OA
Primary
Part 2 OA: GMI of Antigen 1 Antibody Titers
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 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
Part 2 OA: Flu mRNA_10_OA
OA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
OG001
Part 2 OA: Comparator_2_OA
OA participants received a single dose of Comparator 2 administered at Day 1.
Units
Counts
Participants
OG000
Primary
Part 1 YA: 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 duration were included.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 (baseline) to Day 29
ID
Title
Description
OG000
Part 1 YA: Flu mRNA_1_Younger Adults (YA)
YA participants received a single dose of Flu mRNA study intervention F2G22B/DL001Z administered at Day 1.
OG001
Part 1 YA: Flu mRNA_2_YA
YA participants received a single dose of Flu mRNA study intervention F2H23D/DL001Z-NH administered at Day 1.
OG002
Part 1 YA: Flu mRNA_3_YA
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
Primary
Part 2 YA: Percentage of Participants With Antigen 1 Antibody 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 specified analysis at the specified timepoints were included.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 (baseline) to Day 29
ID
Title
Description
OG000
Part 2 YA: Flu mRNA_9_YA
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
OG001
Part 2 YA: Comparator_2_YA
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
Units
Counts
Participants
Primary
Part 1 OA: Percentage of Participants With Antigen 1 Antibody 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 specified analysis at the specified timepoints were included.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 (baseline) to Day 29
ID
Title
Description
OG000
Part 1 OA: Flu mRNA_5_Older Adults (OA)
OA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
OG001
Part 1 OA: Flu mRNA_6_OA
OA participants received a single dose of Flu mRNA study intervention F2H23A/DL001Z-NH administered at Day 1.
OG002
Part 1 OA: Flu mRNA_7_OA
OA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
Primary
Part 2 OA: Percentage of Participants With Antigen 1 Antibody 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 specified analysis at the specified timepoints were included.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 (baseline) to Day 29
ID
Title
Description
OG000
Part 2 OA: Flu mRNA_10_OA
OA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
OG001
Part 2 OA: Comparator_2_OA
OA participants received a single dose of Comparator 2 administered at Day 1.
Units
Counts
Participants
Primary
Part 1 YA: 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 Per Protocol Set (PPS), which included all eligible participants who received the study intervention dose according to the protocol, had immunogenicity results at Day 1, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination before Day 29. Only participants with data available for the specified analysis at the specified timepoints are included.
Posted
Number
95% Confidence Interval
Percentage of participants
At Day 1
ID
Title
Description
OG000
Part 1 YA: Flu mRNA_1_Younger Adults (YA)
YA participants received a single dose of Flu mRNA study intervention F2G22B/DL001Z administered at Day 1.
OG001
Part 1 YA: Flu mRNA_2_YA
YA participants received a single dose of Flu mRNA study intervention F2H23D/DL001Z-NH administered at Day 1.
OG002
Part 1 YA: Flu mRNA_3_YA
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
Primary
Part 2 YA: Percentage of Participants With Antigen 1 Antibody 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
Part 2 YA: Flu mRNA_9_YA
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
OG001
Part 2 YA: Comparator_2_YA
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
Units
Counts
Participants
OG000
Primary
Part 1 OA: Percentage of Participants With Antigen 1 Antibody 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 specified analysis at the specified timepoints were included.
Posted
Number
95% Confidence Interval
Percentage of participants
At Day 1
ID
Title
Description
OG000
Part 1 OA: Flu mRNA_5_Older Adults (OA)
OA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
OG001
Part 1 OA: Flu mRNA_6_OA
OA participants received a single dose of Flu mRNA study intervention F2H23A/DL001Z-NH administered at Day 1.
OG002
Part 1 OA: Flu mRNA_7_OA
OA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
OG003
Part 1 OA: Flu mRNA_8_OA
Primary
Part 2 OA: Percentage of Participants With Antigen 1 Antibody 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 specified analysis at the specified timepoints were included.
Posted
Number
95% Confidence Interval
Percentage of participants
At Day 1
ID
Title
Description
OG000
Part 2 OA: Flu mRNA_10_OA
OA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
OG001
Part 2 OA: Comparator_2_OA
OA participants received a single dose of Comparator 2 administered at Day 1.
Units
Counts
Participants
OG000
Primary
Part 1 YA: Percentage of Participants With Antigen 1 Antibody 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 29
ID
Title
Description
OG000
Part 1 YA: Flu mRNA_1_Younger Adults (YA)
YA participants received a single dose of Flu mRNA study intervention F2G22B/DL001Z administered at Day 1.
OG001
Part 1 YA: Flu mRNA_2_YA
YA participants received a single dose of Flu mRNA study intervention F2H23D/DL001Z-NH administered at Day 1.
OG002
Part 1 YA: Flu mRNA_3_YA
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
OG003
Part 1 YA: Flu mRNA_4_YA
Primary
Part 2 YA: Percentage of Participants With Antigen 1 Antibody 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 specified analysis at the specified timepoints were included.
Posted
Number
95% Confidence Interval
Percentage of participants
At Day 29
ID
Title
Description
OG000
Part 2 YA: Flu mRNA_9_YA
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
OG001
Part 2 YA: Comparator_2_YA
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
Units
Counts
Participants
OG000
Primary
Part 1 OA: Percentage of Participants With Antigen 1 Antibody 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 specified analysis at the specified timepoints were included.
Posted
Number
95% Confidence Interval
Percentage of participants
At Day 29
ID
Title
Description
OG000
Part 1 OA: Flu mRNA_5_Older Adults (OA)
OA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
OG001
Part 1 OA: Flu mRNA_6_OA
OA participants received a single dose of Flu mRNA study intervention F2H23A/DL001Z-NH administered at Day 1.
OG002
Part 1 OA: Flu mRNA_7_OA
OA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
OG003
Part 1 OA: Flu mRNA_8_OA
Primary
Part 2 OA: Percentage of Participants With Antigen 1 Antibody 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 specified analysis at the specified timepoints were included.
Posted
Number
95% Confidence Interval
Percentage of participants
At Day 29
ID
Title
Description
OG000
Part 2 OA: Flu mRNA_10_OA
OA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
OG001
Part 2 OA: Comparator_2_OA
OA participants received a single dose of Comparator 2 administered at Day 1.
Units
Counts
Participants
OG000
Secondary
Part 1 YA: 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
Part 1 YA: Flu mRNA_1_Younger Adults (YA)
YA participants received a single dose of Flu mRNA study intervention F2G22B/DL001Z administered at Day 1.
OG001
Part 1 YA: Flu mRNA_2_YA
YA participants received a single dose of Flu mRNA study intervention F2H23D/DL001Z-NH administered at Day 1.
OG002
Part 1 YA: Flu mRNA_3_YA
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
OG003
Part 1 YA: Flu mRNA_4_YA
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
OG004
Secondary
Part 2 YA: GMT of Antigen 2 Antibody Titer
The analysis was performed on the PPS. Only participants with data available for specified analysis at the specified timepoints were included.
Posted
Geometric Mean
95% Confidence Interval
Titers
At Day 29
ID
Title
Description
OG000
Part 2 YA: Flu mRNA_9_YA
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
OG001
Part 2 YA: Comparator_2_YA
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
Units
Counts
Participants
OG000
Secondary
Part 1 OA: GMT of Antigen 2 Antibody Titer
The analysis was performed on the PPS. Only participants with data available for specified analysis at the specified timepoints were included.
Posted
Geometric Mean
95% Confidence Interval
Titers
At Day 29
ID
Title
Description
OG000
Part 1 OA: Flu mRNA_5_Older Adults (OA)
OA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
OG001
Part 1 OA: Flu mRNA_6_OA
OA participants received a single dose of Flu mRNA study intervention F2H23A/DL001Z-NH administered at Day 1.
OG002
Part 1 OA: Flu mRNA_7_OA
OA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
OG003
Part 1 OA: Flu mRNA_8_OA
OA participants received a single dose of Flu mRNA study intervention F2H23G/DL001Z administered at Day 1.
OG004
Secondary
Part 2 OA: GMT of Antigen 2 Antibody Titer
The analysis was performed on the PPS. Only participants with data available for specified analysis at the specified timepoints were included.
Posted
Geometric Mean
95% Confidence Interval
Titers
At Day 29
ID
Title
Description
OG000
Part 2 OA: Flu mRNA_10_OA
OA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
OG001
Part 2 OA: Comparator_2_OA
OA participants received a single dose of Comparator 2 administered at Day 1.
Units
Counts
Participants
OG000
Secondary
Part 1 YA: GMI of Antigen 2 Antibody Titer
The analysis was performed on the PPS. Only participants with data available for 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
Part 1 YA: Flu mRNA_1_Younger Adults (YA)
YA participants received a single dose of Flu mRNA study intervention F2G22B/DL001Z administered at Day 1.
OG001
Part 1 YA: Flu mRNA_2_YA
YA participants received a single dose of Flu mRNA study intervention F2H23D/DL001Z-NH administered at Day 1.
OG002
Part 1 YA: Flu mRNA_3_YA
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
OG003
Part 1 YA: Flu mRNA_4_YA
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
OG004
Secondary
Part 2 YA: GMI of Antigen 2 Antibody Titer
The analysis was performed on the PPS. Only participants with data available for 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
Part 2 YA: Flu mRNA_9_YA
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
OG001
Part 2 YA: Comparator_2_YA
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
Units
Counts
Participants
OG000
Secondary
Part 1 OA: GMI of Antigen 2 Antibody Titer
The analysis was performed on the PPS. Only participants with data available for 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
Part 1 OA: Flu mRNA_5_Older Adults (OA)
OA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
OG001
Part 1 OA: Flu mRNA_6_OA
OA participants received a single dose of Flu mRNA study intervention F2H23A/DL001Z-NH administered at Day 1.
OG002
Part 1 OA: Flu mRNA_7_OA
OA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
OG003
Part 1 OA: Flu mRNA_8_OA
OA participants received a single dose of Flu mRNA study intervention F2H23G/DL001Z administered at Day 1.
OG004
Secondary
Part 2 OA: GMI of Antigen 2 Antibody Titer
The analysis was performed on the PPS. Only participants with data available for 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
Part 2 OA: Flu mRNA_10_OA
OA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
OG001
Part 2 OA: Comparator_2_OA
OA participants received a single dose of Comparator 2 administered at Day 1.
Units
Counts
Participants
OG000
Secondary
Part 1 YA: Percentage of Participants With Antigen 2 Antibody SCR
The analysis was performed on the PPS. Only participants with data available for specified analysis at the specified timepoints were included.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 (baseline) to Day 29
ID
Title
Description
OG000
Part 1 YA: Flu mRNA_1_Younger Adults (YA)
YA participants received a single dose of Flu mRNA study intervention F2G22B/DL001Z administered at Day 1.
OG001
Part 1 YA: Flu mRNA_2_YA
YA participants received a single dose of Flu mRNA study intervention F2H23D/DL001Z-NH administered at Day 1.
OG002
Part 1 YA: Flu mRNA_3_YA
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
OG003
Part 1 YA: Flu mRNA_4_YA
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
Secondary
Part 2 YA: Percentage of Participants With Antigen 2 Antibody SCR
The analysis was performed on the PPS. Only participants with data available for specified analysis at the specified timepoints were included.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 (baseline) to Day 29
ID
Title
Description
OG000
Part 2 YA: Flu mRNA_9_YA
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
OG001
Part 2 YA: Comparator_2_YA
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
Units
Counts
Participants
OG000
Secondary
Part 1 OA: Percentage of Participants With Antigen 2 Antibody SCR
The analysis was performed on the PPS. Only participants with data available for specified analysis at the specified timepoints were included.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 (baseline) to Day 29
ID
Title
Description
OG000
Part 1 OA: Flu mRNA_5_Older Adults (OA)
OA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
OG001
Part 1 OA: Flu mRNA_6_OA
OA participants received a single dose of Flu mRNA study intervention F2H23A/DL001Z-NH administered at Day 1.
OG002
Part 1 OA: Flu mRNA_7_OA
OA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
OG003
Part 1 OA: Flu mRNA_8_OA
OA participants received a single dose of Flu mRNA study intervention F2H23G/DL001Z administered at Day 1.
Secondary
Part 2 OA: Percentage of Participants With Antigen 2 Antibody SCR
The analysis was performed on the PPS. Only participants with data available for specified analysis at the specified timepoints were included.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day 1 (baseline) to Day 29
ID
Title
Description
OG000
Part 2 OA: Flu mRNA_10_OA
OA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
OG001
Part 2 OA: Comparator_2_OA
OA participants received a single dose of Comparator 2 administered at Day 1.
Units
Counts
Participants
OG000
Secondary
Part 1 YA: 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.
The analysis was performed on the Exposed Set (ES), which included all participants who received a study intervention and with data available for specified analysis at the specified duration were included.
Posted
Count of Participants
Participants
Day 1 to Day 7
ID
Title
Description
OG000
Part 1 YA: Flu mRNA_1_Younger Adults (YA)
YA participants received a single dose of Flu mRNA study intervention F2G22B/DL001Z administered at Day 1.
OG001
Part 1 YA: Flu mRNA_2_YA
YA participants received a single dose of Flu mRNA study intervention F2H23D/DL001Z-NH administered at Day 1.
OG002
Part 1 YA: Flu mRNA_3_YA
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
Secondary
Part 2 YA: Number of Participants Reporting Any Solicited Administration Site 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.
The analysis was performed on the ES, which included all participants who received a study intervention and with data available for specified analysis at the specified duration were included.
Posted
Count of Participants
Participants
Day 1 to Day 7
ID
Title
Description
OG000
Part 2 YA: Flu mRNA_9_YA
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
OG001
Part 2 YA: Comparator_2_YA
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
Units
Counts
Participants
Secondary
Part 1 OA: Number of Participants Reporting Any Solicited Administration Site 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.
The analysis was performed on the ES, which included all participants who received a study intervention and with data available for specified analysis at the specified duration were included.
Posted
Count of Participants
Participants
Day 1 to Day 7
ID
Title
Description
OG000
Part 1 OA: Flu mRNA_5_Older Adults (OA)
OA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
OG001
Part 1 OA: Flu mRNA_6_OA
OA participants received a single dose of Flu mRNA study intervention F2H23A/DL001Z-NH administered at Day 1.
OG002
Part 1 OA: Flu mRNA_7_OA
OA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
OG003
Secondary
Part 2 OA: Number of Participants Reporting Any Solicited Administration Site 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.
The analysis was performed on the ES, which included all participants who received a study intervention and with data available for specified analysis at the specified duration were included.
Posted
Count of Participants
Participants
Day 1 to Day 7
ID
Title
Description
OG000
Part 2 OA: Flu mRNA_10_OA
OA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
OG001
Part 2 OA: Comparator_2_OA
OA participants received a single dose of Comparator 2 administered at Day 1.
Units
Counts
Participants
Secondary
Part 1 YA: Number of Participants Reporting Any Solicited Systemic AEs
Assessed solicited systemic events included fever (pyrexia) which is defined as axillary temperature greater than or equal to (>=) 38.0°C/100.4°F, chills, headache, fatigue (tiredness), myalgia (muscle joint), and arthralgia (joint pain). Any = occurrence of the event regardless of intensity grade.
The analysis was performed on the ES, which included all participants who received a study intervention and with data available at the specified duration.
Posted
Count of Participants
Participants
Day 1 to Day 7
ID
Title
Description
OG000
Part 1 YA: Flu mRNA_1_Younger Adults (YA)
YA participants received a single dose of Flu mRNA study intervention F2G22B/DL001Z administered at Day 1.
OG001
Part 1 YA: Flu mRNA_2_YA
YA participants received a single dose of Flu mRNA study intervention F2H23D/DL001Z-NH administered at Day 1.
OG002
Part 1 YA: Flu mRNA_3_YA
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
OG003
Secondary
Part 2 YA: Number of Participants Reporting Any Solicited Systemic AEs
Assessed solicited systemic events included fever (pyrexia) which is defined as axillary temperature >= 38.0°C/100.4°F, chills, headache, fatigue (tiredness), myalgia (muscle joint), and arthralgia (joint pain). Any = occurrence of the event regardless of intensity grade.
The analysis was performed on the ES, which included all participants who received a study intervention and with data available for specified analysis at the specified duration were included.
Posted
Count of Participants
Participants
Day 1 to Day 7
ID
Title
Description
OG000
Part 2 YA: Flu mRNA_9_YA
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
OG001
Part 2 YA: Comparator_2_YA
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
Units
Counts
Participants
OG000
Secondary
Part 1 OA: Number of Participants Reporting Any Solicited Systemic AEs
Assessed solicited systemic events included fever (pyrexia) which is defined as axillary temperature >= 38.0°C/100.4°F, chills, headache, fatigue (tiredness), myalgia (muscle joint), and arthralgia (joint pain). Any = occurrence of the event regardless of intensity grade.
The analysis was performed on the ES, which included all participants who received a study intervention and with data available for specified analysis at the specified duration were included.
Posted
Count of Participants
Participants
Day 1 to Day 7
ID
Title
Description
OG000
Part 1 OA: Flu mRNA_5_Older Adults (OA)
OA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
OG001
Part 1 OA: Flu mRNA_6_OA
OA participants received a single dose of Flu mRNA study intervention F2H23A/DL001Z-NH administered at Day 1.
OG002
Part 1 OA: Flu mRNA_7_OA
OA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
OG003
Secondary
Part 2 OA: Number of Participants Reporting Any Solicited Systemic AEs
Assessed solicited systemic events included fever (pyrexia) which is defined as axillary temperature >= 38.0°C/100.4°F, chills, headache, fatigue (tiredness), myalgia (muscle joint), and arthralgia (joint pain). Any = occurrence of the event regardless of intensity grade.
The analysis was performed on the ES, which included all participants who received a study intervention and with data available for specified analysis at the specified duration were included.
Posted
Count of Participants
Participants
Day 1 to Day 7
ID
Title
Description
OG000
Part 2 OA: Flu mRNA_10_OA
OA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
OG001
Part 2 OA: Comparator_2_OA
OA participants received a single dose of Comparator 2 administered at Day 1.
Units
Counts
Participants
OG000
Secondary
Part 1 YA: 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.
The analysis was performed on the ES, which included all participants who received a study intervention and with data available for specified analysis at the specified duration were included.
Posted
Count of Participants
Participants
Day 1 to Day 28
ID
Title
Description
OG000
Part 1 YA: Flu mRNA_1_Younger Adults (YA)
YA participants received a single dose of Flu mRNA study intervention F2G22B/DL001Z administered at Day 1.
OG001
Part 1 YA: Flu mRNA_2_YA
YA participants received a single dose of Flu mRNA study intervention F2H23D/DL001Z-NH administered at Day 1.
OG002
Part 1 YA: Flu mRNA_3_YA
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
Secondary
Part 2 YA: 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.
The analysis was performed on the ES, which included all participants who received a study intervention and with data available for specified analysis at the specified duration were included.
Posted
Count of Participants
Participants
Day 1 to Day 28
ID
Title
Description
OG000
Part 2 YA: Flu mRNA_9_YA
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
OG001
Part 2 YA: Comparator_2_YA
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
Units
Counts
Participants
Secondary
Part 1 OA: 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.
The analysis was performed on the ES, which included all participants who received a study intervention and with data available for specified analysis at the specified duration were included.
Posted
Count of Participants
Participants
Day 1 to Day 28
ID
Title
Description
OG000
Part 1 OA: Flu mRNA_5_Older Adults (OA)
OA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
OG001
Part 1 OA: Flu mRNA_6_OA
OA participants received a single dose of Flu mRNA study intervention F2H23A/DL001Z-NH administered at Day 1.
OG002
Part 1 OA: Flu mRNA_7_OA
OA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
Secondary
Part 2 OA: 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.
The analysis was performed on the ES, which included all participants who received a study intervention and with data available for specified analysis at the specified duration were included.
Posted
Count of Participants
Participants
Day 1 to Day 28
ID
Title
Description
OG000
Part 2 OA: Flu mRNA_10_OA
OA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
OG001
Part 2 OA: Comparator_2_OA
OA participants received a single dose of Comparator 2 administered at Day 1.
Units
Counts
Participants
Secondary
Part 1 YA: 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.
The analysis was performed on the ES, which included all participants who received a study intervention.
Posted
Count of Participants
Participants
Day 1 to Day 183
ID
Title
Description
OG000
Part 1 YA: Flu mRNA_1_Younger Adults (YA)
YA participants received a single dose of Flu mRNA study intervention F2G22B/DL001Z administered at Day 1.
OG001
Part 1 YA: Flu mRNA_2_YA
YA participants received a single dose of Flu mRNA study intervention F2H23D/DL001Z-NH administered at Day 1.
OG002
Part 1 YA: Flu mRNA_3_YA
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
Secondary
Part 2 YA: Number of Participants Reporting 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.
The analysis was performed on the ES, which included all participants who received a study intervention.
Posted
Count of Participants
Participants
Day 1 to Day 183
ID
Title
Description
OG000
Part 2 YA: Flu mRNA_9_YA
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
OG001
Part 2 YA: Comparator_2_YA
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
Units
Counts
Participants
Secondary
Part 1 OA: Number of Participants Reporting 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.
The analysis was performed on the ES, which included all participants who received a study intervention.
Posted
Count of Participants
Participants
Day 1 to Day 183
ID
Title
Description
OG000
Part 1 OA: Flu mRNA_5_Older Adults (OA)
OA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
OG001
Part 1 OA: Flu mRNA_6_OA
OA participants received a single dose of Flu mRNA study intervention F2H23A/DL001Z-NH administered at Day 1.
OG002
Part 1 OA: Flu mRNA_7_OA
OA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
Secondary
Part 2 OA: Number of Participants Reporting 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.
The analysis was performed on the ES, which included all participants who received a study intervention.
Posted
Count of Participants
Participants
Day 1 to Day 183
ID
Title
Description
OG000
Part 2 OA: Flu mRNA_10_OA
OA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
OG001
Part 2 OA: Comparator_2_OA
OA participants received a single dose of Comparator 2 (Fluzone HD) administered at Day 1.
Units
Counts
Participants
Secondary
Part 1 YA: 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.
The analysis was performed on the ES, which included all participants who received a study intervention.
Posted
Count of Participants
Participants
Day 1 to Day 183
ID
Title
Description
OG000
Part 1 YA: Flu mRNA_1_Younger Adults (YA)
YA participants received a single dose of Flu mRNA study intervention F2G22B/DL001Z administered at Day 1.
OG001
Part 1 YA: Flu mRNA_2_YA
YA participants received a single dose of Flu mRNA study intervention F2H23D/DL001Z-NH administered at Day 1.
OG002
Part 1 YA: Flu mRNA_3_YA
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
OG003
Part 1 YA: Flu mRNA_4_YA
Secondary
Part 2 YA: Number of Participants Reporting 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.
The analysis was performed on the ES, which included all participants who received a study intervention.
Posted
Count of Participants
Participants
Day 1 to Day 183
ID
Title
Description
OG000
Part 2 YA: Flu mRNA_9_YA
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
OG001
Part 2 YA: Comparator_2_YA
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
Units
Counts
Participants
OG000
Secondary
Part 1 OA: Number of Participants Reporting 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.
The analysis was performed on the ES, which included all participants who received a study intervention.
Posted
Count of Participants
Participants
Day 1 to Day 183
ID
Title
Description
OG000
Part 1 OA: Flu mRNA_5_Older Adults (OA)
OA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
OG001
Part 1 OA: Flu mRNA_6_OA
OA participants received a single dose of Flu mRNA study intervention F2H23A/DL001Z-NH administered at Day 1.
OG002
Part 1 OA: Flu mRNA_7_OA
OA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
OG003
Part 1 OA: Flu mRNA_8_OA
Secondary
Part 2 OA: Number of Participants Reporting 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.
The analysis was performed on the ES, which included all participants who received a study intervention.
Posted
Count of Participants
Participants
Day 1 to Day 183
ID
Title
Description
OG000
Part 2 OA: Flu mRNA_10_OA
OA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
OG001
Part 2 OA: Comparator_2_OA
OA participants received a single dose of Comparator 2 administered at Day 1.
Units
Counts
Participants
OG000
Secondary
Part 1 YA: Number of Participants Reporting Medically Attended Adverse Events (MAAEs)
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.
The analysis was performed on the ES, which included all participants who received a study intervention.
Posted
Count of Participants
Participants
Day 1 to Day 183
ID
Title
Description
OG000
Part 1 YA: Flu mRNA_1_Younger Adults (YA)
YA participants received a single dose of Flu mRNA study intervention F2G22B/DL001Z administered at Day 1.
OG001
Part 1 YA: Flu mRNA_2_YA
YA participants received a single dose of Flu mRNA study intervention F2H23D/DL001Z-NH administered at Day 1.
OG002
Part 1 YA: Flu mRNA_3_YA
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
OG003
Part 1 YA: Flu mRNA_4_YA
Secondary
Part 2 YA: Number of Participants Reporting MAAEs
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.
The analysis was performed on the ES, which included all participants who received a study intervention.
Posted
Count of Participants
Participants
Day 1 to Day 183
ID
Title
Description
OG000
Part 2 YA: Flu mRNA_9_YA
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
OG001
Part 2 YA: Comparator_2_YA
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
Units
Counts
Participants
OG000
Secondary
Part 1 OA: Number of Participants Reporting MAAEs
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.
The analysis was performed on the ES, which included all participants who received a study intervention.
Posted
Count of Participants
Participants
Day 1 to Day 183
ID
Title
Description
OG000
Part 1 OA: Flu mRNA_5_Older Adults (OA)
OA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
OG001
Part 1 OA: Flu mRNA_6_OA
OA participants received a single dose of Flu mRNA study intervention F2H23A/DL001Z-NH administered at Day 1.
OG002
Part 1 OA: Flu mRNA_7_OA
OA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
OG003
Part 1 OA: Flu mRNA_8_OA
Secondary
Part 2 OA: Number of Participants Reporting MAAEs
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.
The analysis was performed on the ES, which included all participants who received a study intervention.
Posted
Count of Participants
Participants
Day 1 to Day 183
ID
Title
Description
OG000
Part 2 OA: Flu mRNA_10_OA
OA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
OG001
Part 2 OA: Comparator_2_OA
OA participants received a single dose of Comparator 2 administered at Day 1.
Units
Counts
Participants
OG000
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
Part 1 YA: Flu mRNA_1_Younger Adults (YA)
YA participants received a single dose of Flu mRNA study intervention F2G22B/DL001Z administered at Day 1.
0
50
0
50
31
50
EG001
Part 1 YA: Flu mRNA_2_YA
YA participants received a single dose of Flu mRNA study intervention F2H23D/DL001Z-NH administered at Day 1.
0
50
1
50
33
50
EG002
Part 1 YA: Flu mRNA_3_YA
YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
0
48
1
48
33
48
EG003
Part 1 YA: Flu mRNA_4_YA
YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
0
50
2
50
34
50
EG004
Part 1 YA: Comparator_1_YA
YA participants received a single dose of Comparator 1 ([FDQ23A-NH (Flu D-QIV)] administered at Day 1.
0
52
2
52
29
52
EG005
Part 2 YA: Flu mRNA_9_YA
YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
0
81
0
81
54
81
EG006
Part 2 YA: Comparator_2_YA
YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1.
0
80
0
80
39
80
EG007
Part 1 OA: Flu mRNA_5_Older Adults (OA)
OA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1.
0
51
3
51
37
51
EG008
Part 1 OA: Flu mRNA_6_OA
OA participants received a single dose of Flu mRNA study intervention F2H23A/DL001Z-NH administered at Day 1.
0
52
2
52
39
52
EG009
Part 1 OA: Flu mRNA_7_OA
OA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1.
0
53
3
53
39
53
EG010
Part 1 OA: Flu mRNA_8_OA
OA participants received a single dose of Flu mRNA study intervention F2H23G/DL001Z administered at Day 1.
0
51
1
51
40
51
EG011
Part 1 OA: Comparator_1_OA
OA participants received a single dose of Comparator 1 (Fluzone HD Quadrivalent) administered at Day 1.
0
53
0
53
36
53
EG012
Part 2 OA: Flu mRNA_10_OA
OA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1.
0
82
0
82
48
82
EG013
Part 2 OA: Comparator_2_OA
OA participants received a single dose of Comparator 2 (Fluzone HD) administered at Day 1.
0
80
0
80
33
80
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Atrial flutter
Cardiac disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG0030 events0 affected50 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected81 at risk
EG0060 events0 affected80 at risk
EG0071 events1 affected51 at risk
EG0080 events0 affected52 at risk
EG0090 events0 affected53 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected53 at risk
EG0120 events0 affected82 at risk
EG0130 events0 affected80 at risk
Lemierre syndrome
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Ophthalmic herpes zoster
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Sepsis
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Urinary tract infection bacterial
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0021 events1 affected48 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Multiple injuries
Injury, poisoning and procedural complications
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Ulna fracture
Injury, poisoning and procedural complications
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Bladder cancer stage IV
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Invasive ductal breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Cerebrovascular accident
Nervous system disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Ischaemic stroke
Nervous system disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Subarachnoid haemorrhage
Nervous system disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Syncope
Nervous system disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Mental status changes
Psychiatric disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Chronic kidney disease
Renal and urinary disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0021 events1 affected48 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG0030 events0 affected50 at risk
EG0040 events0 affected52 at risk
EG0050 events0 affected81 at risk
EG0060 events0 affected80 at risk
EG0070 events0 affected51 at risk
EG0080 events0 affected52 at risk
EG0090 events0 affected53 at risk
EG0100 events0 affected51 at risk
EG0110 events0 affected53 at risk
EG0120 events0 affected82 at risk
EG0131 events1 affected80 at risk
Lymphadenopathy
Blood and lymphatic system disorders
v28.0
Systematic Assessment
EG0004 events4 affected50 at risk
EG0019 events9 affected50 at risk
EG00210 events10 affected48 at risk
EG003
Microcytic anaemia
Blood and lymphatic system disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Polycythaemia
Blood and lymphatic system disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Atrial fibrillation
Cardiac disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Cerumen impaction
Ear and labyrinth disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Ear pain
Ear and labyrinth disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Vertigo
Ear and labyrinth disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Cataract
Eye disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Conjunctivitis allergic
Eye disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Eye discharge
Eye disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Vision blurred
Eye disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Abdominal pain
Gastrointestinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Diarrhoea
Gastrointestinal disorders
v28.0
Systematic Assessment
EG0001 events1 affected50 at risk
EG0012 events2 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Dyspepsia
Gastrointestinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Haematemesis
Gastrointestinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Nausea
Gastrointestinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Vomiting
Gastrointestinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0013 events1 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Administration site erythema
General disorders
v28.0
Systematic Assessment
EG0002 events2 affected50 at risk
EG0014 events4 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Administration site pain
General disorders
v28.0
Systematic Assessment
EG00025 events25 affected50 at risk
EG00131 events31 affected50 at risk
EG00230 events30 affected48 at risk
EG003
Administration site swelling
General disorders
v28.0
Systematic Assessment
EG0002 events2 affected50 at risk
EG0014 events4 affected50 at risk
EG0021 events1 affected48 at risk
EG003
Chest pain
General disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Chills
General disorders
v28.0
Systematic Assessment
EG0005 events5 affected50 at risk
EG00115 events15 affected50 at risk
EG00216 events16 affected48 at risk
EG003
Fatigue
General disorders
v28.0
Systematic Assessment
EG00017 events17 affected50 at risk
EG00124 events24 affected50 at risk
EG00222 events21 affected48 at risk
EG003
Injection site bruising
General disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0011 events1 affected50 at risk
EG0021 events1 affected48 at risk
EG003
Injection site erythema
General disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Injection site pain
General disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Injection site pruritus
General disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Pain
General disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Pyrexia
General disorders
v28.0
Systematic Assessment
EG0002 events2 affected50 at risk
EG0011 events1 affected50 at risk
EG0026 events6 affected48 at risk
EG003
Swelling
General disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Metabolic dysfunction-associated liver disease
Hepatobiliary disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0021 events1 affected48 at risk
EG003
Nutritional supplement allergy
Immune system disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Bronchitis
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Bronchitis viral
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
COVID-19
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Cellulitis
Infections and infestations
v28.0
Systematic Assessment
EG0001 events1 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Diverticulitis
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Ear infection
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Gastroenteritis
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Gastroenteritis viral
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Herpes simplex
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Herpes zoster
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Influenza
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Nasopharyngitis
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Onychomycosis
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Oral herpes
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Pharyngitis
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0021 events1 affected48 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Respiratory tract infection
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Sinusitis
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Thrombophlebitis septic
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Upper respiratory tract infection
Infections and infestations
v28.0
Systematic Assessment
EG0001 events1 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Urinary tract infection
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0021 events1 affected48 at risk
EG003
Viral infection
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Fall
Injury, poisoning and procedural complications
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Hepatic enzyme increased
Investigations
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Influenza A virus test positive
Investigations
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Influenza B virus test positive
Investigations
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Dehydration
Metabolism and nutrition disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0021 events1 affected48 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0021 events1 affected48 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
v28.0
Systematic Assessment
EG0006 events6 affected50 at risk
EG00113 events13 affected50 at risk
EG00213 events13 affected48 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
v28.0
Systematic Assessment
EG00020 events20 affected50 at risk
EG00127 events27 affected50 at risk
EG00224 events24 affected48 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Periarthritis
Musculoskeletal and connective tissue disorders
v28.0
Systematic Assessment
EG0001 events1 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Plantar fasciitis
Musculoskeletal and connective tissue disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Benign neoplasm of thyroid gland
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Aphasia
Nervous system disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Carpal tunnel syndrome
Nervous system disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Dizziness
Nervous system disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Dysgeusia
Nervous system disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Headache
Nervous system disorders
v28.0
Systematic Assessment
EG00015 events15 affected50 at risk
EG00125 events24 affected50 at risk
EG00223 events22 affected48 at risk
EG003
Migraine
Nervous system disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Parkinson's disease
Nervous system disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Presyncope
Nervous system disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Anxiety
Psychiatric disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Insomnia
Psychiatric disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Suicidal ideation
Psychiatric disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Acute kidney injury
Renal and urinary disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Haematuria
Renal and urinary disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Renal disorder
Renal and urinary disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Urinary incontinence
Renal and urinary disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
v28.0
Systematic Assessment
EG0001 events1 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Nasal odour
Respiratory, thoracic and mediastinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Pleurisy
Respiratory, thoracic and mediastinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Haematoma
Vascular disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Hot flush
Vascular disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0011 events1 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Hypertension
Vascular disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 at risk
EG003
Hypotension
Vascular disorders
v28.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected50 at risk
EG0020 events0 affected48 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.