A Study to Assess the Safety and Immune Response of a Vaccine Against Influenza in Healthy Younger and Older Adults

• ClinicalTrials.gov Identifier: NCT05823974
• Recruitment Status: Active, not recruiting
• First Posted: April 21, 2023
• Last Update Posted: March 1, 2024
• Sponsor: GlaxoSmithKline
• Collaborator: CureVac
• Information provided by (Responsible Party): GlaxoSmithKline

Study Description

Brief Summary:

The purpose of this study is to find and confirm the dose and asses the reactogenicity, safety and immune response of GlaxoSmithKline's (GSK) messenger RNA (mRNA)-based multivalent seasonal influenza vaccine (GSK4382276A) candidates administered in healthy younger and older adults (OA).

Condition or disease	Intervention/treatment	Phase
Influenza, Human	Biological: Flu mRNA; Combination Product: Control 1; Combination Product: Control 2	Phase 1; Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1256 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Phase 2 of this study will be observer blind.
• Primary Purpose: Prevention
• Official Title: A Phase 1/2, Randomized, Dose-finding/Dose-confirmation Study to Evaluate the Reactogenicity, Safety and Immunogenicity of mRNA-based Multivalent Seasonal Influenza Vaccine Candidates Administered in Healthy Younger and Older Adults
• Actual Study Start Date: February 27, 2023
• Estimated Primary Completion Date: July 11, 2024
• Estimated Study Completion Date: August 12, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Flu mRNA_1_1 Group; Eligible Younger Adults (YA) participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 1 administered in Phase 1, at Day 1.	Biological: Flu mRNA; Different formulations of Flu mRNA (GSK4382276A) study intervention is administered intramuscularly in the non-dominant upper deltoid to YA and OA participants in Phase 1 and Phase 2, at Day 1.; Other Name: GSK4382276A
Experimental: Flu mRNA_1_2 Group; Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 2 administered in Phase 1, at Day 1.	Biological: Flu mRNA; Different formulations of Flu mRNA (GSK4382276A) study intervention is administered intramuscularly in the non-dominant upper deltoid to YA and OA participants in Phase 1 and Phase 2, at Day 1.; Other Name: GSK4382276A
Experimental: Flu mRNA_1_3 Group; Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 3 administered in Phase 1, at Day 1.	Biological: Flu mRNA; Different formulations of Flu mRNA (GSK4382276A) study intervention is administered intramuscularly in the non-dominant upper deltoid to YA and OA participants in Phase 1 and Phase 2, at Day 1.; Other Name: GSK4382276A
Experimental: Flu mRNA_1_4 Group; Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 4 administered in Phase 1, at Day 1.	Biological: Flu mRNA; Different formulations of Flu mRNA (GSK4382276A) study intervention is administered intramuscularly in the non-dominant upper deltoid to YA and OA participants in Phase 1 and Phase 2, at Day 1.; Other Name: GSK4382276A
Experimental: Flu mRNA_1_5 Group; Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 5 administered in Phase 1, at Day 1.	Biological: Flu mRNA; Different formulations of Flu mRNA (GSK4382276A) study intervention is administered intramuscularly in the non-dominant upper deltoid to YA and OA participants in Phase 1 and Phase 2, at Day 1.; Other Name: GSK4382276A
Experimental: Flu mRNA_1_6 Group; Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 6 administered in Phase 1, at Day 1.	Biological: Flu mRNA; Different formulations of Flu mRNA (GSK4382276A) study intervention is administered intramuscularly in the non-dominant upper deltoid to YA and OA participants in Phase 1 and Phase 2, at Day 1.; Other Name: GSK4382276A
Experimental: Flu mRNA_1_7 Group; Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 7 administered in Phase 1, at Day 1.	Biological: Flu mRNA; Different formulations of Flu mRNA (GSK4382276A) study intervention is administered intramuscularly in the non-dominant upper deltoid to YA and OA participants in Phase 1 and Phase 2, at Day 1.; Other Name: GSK4382276A
Experimental: Flu mRNA_1_8 Group; Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 8 administered in Phase 1, at Day 1.	Biological: Flu mRNA; Different formulations of Flu mRNA (GSK4382276A) study intervention is administered intramuscularly in the non-dominant upper deltoid to YA and OA participants in Phase 1 and Phase 2, at Day 1.; Other Name: GSK4382276A
Experimental: Flu mRNA_1_9 Group; Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 9 administered in Phase 1, at Day 1.	Biological: Flu mRNA; Different formulations of Flu mRNA (GSK4382276A) study intervention is administered intramuscularly in the non-dominant upper deltoid to YA and OA participants in Phase 1 and Phase 2, at Day 1.; Other Name: GSK4382276A
Experimental: Flu mRNA_1_10 Group; Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 10 administered in Phase 1, at Day 1.	Biological: Flu mRNA; Different formulations of Flu mRNA (GSK4382276A) study intervention is administered intramuscularly in the non-dominant upper deltoid to YA and OA participants in Phase 1 and Phase 2, at Day 1.; Other Name: GSK4382276A
Experimental: Flu mRNA_1_11 Group; Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 11 administered in Phase 1, at Day 1.	Biological: Flu mRNA; Different formulations of Flu mRNA (GSK4382276A) study intervention is administered intramuscularly in the non-dominant upper deltoid to YA and OA participants in Phase 1 and Phase 2, at Day 1.; Other Name: GSK4382276A
Experimental: Flu mRNA_1_12 Group; Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 12 administered in Phase 1, at Day 1.	Biological: Flu mRNA; Different formulations of Flu mRNA (GSK4382276A) study intervention is administered intramuscularly in the non-dominant upper deltoid to YA and OA participants in Phase 1 and Phase 2, at Day 1.; Other Name: GSK4382276A
Active Comparator: Control Group; Eligible YA participants receive a single dose of Control 1 administered in Phase 1, at Day 1.	Combination Product: Control 1; Control 1 vaccine is administered intramuscularly in the non-dominant upper deltoid to participants in Control group from Phase 1, at Day 1 and to participants in Control YA group from Phase 2, at Day 1.
Experimental: Flu mRNA_Ph2_1_YA Group; Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 1 administered in Phase 2, at Day 1.	Biological: Flu mRNA; Different formulations of Flu mRNA (GSK4382276A) study intervention is administered intramuscularly in the non-dominant upper deltoid to YA and OA participants in Phase 1 and Phase 2, at Day 1.; Other Name: GSK4382276A
Experimental: Flu mRNA_Ph2_2_YA Group; Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 2 administered in Phase 2, at Day 1.	Biological: Flu mRNA; Different formulations of Flu mRNA (GSK4382276A) study intervention is administered intramuscularly in the non-dominant upper deltoid to YA and OA participants in Phase 1 and Phase 2, at Day 1.; Other Name: GSK4382276A
Experimental: Flu mRNA_Ph2_3_YA Group; Eligible YA participants receive single dose of Flu mRNA (GSK4382276A) study intervention formulation 3 administered in Phase 2, at Day 1.	Biological: Flu mRNA; Different formulations of Flu mRNA (GSK4382276A) study intervention is administered intramuscularly in the non-dominant upper deltoid to YA and OA participants in Phase 1 and Phase 2, at Day 1.; Other Name: GSK4382276A
Active Comparator: Control_Ph2_YA Group; Eligible YA participants receive single dose of Control 1 vaccine administered in Phase 2, at Day 1.	Combination Product: Control 1; Control 1 vaccine is administered intramuscularly in the non-dominant upper deltoid to participants in Control group from Phase 1, at Day 1 and to participants in Control YA group from Phase 2, at Day 1.
Experimental: Flu mRNA_Ph2_1_OA Group; Eligible OA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 4 administered in Phase 2, at Day 1.	Biological: Flu mRNA; Different formulations of Flu mRNA (GSK4382276A) study intervention is administered intramuscularly in the non-dominant upper deltoid to YA and OA participants in Phase 1 and Phase 2, at Day 1.; Other Name: GSK4382276A
Experimental: Flu mRNA_Ph2_2_OA Group; Eligible OA participants receive single dose of Flu mRNA (GSK4382276A) study intervention formulation 5 administered in Phase 2, at Day 1.	Biological: Flu mRNA; Different formulations of Flu mRNA (GSK4382276A) study intervention is administered intramuscularly in the non-dominant upper deltoid to YA and OA participants in Phase 1 and Phase 2, at Day 1.; Other Name: GSK4382276A
Experimental: Flu mRNA_Ph2_3_OA Group; Eligible OA participants receive single dose of Flu mRNA (GSK4382276A) study intervention formulation 6 administered in Phase 2, at Day 1.	Biological: Flu mRNA; Different formulations of Flu mRNA (GSK4382276A) study intervention is administered intramuscularly in the non-dominant upper deltoid to YA and OA participants in Phase 1 and Phase 2, at Day 1.; Other Name: GSK4382276A
Active Comparator: Control_Ph2_OA Group; Eligible OA participants receive a single dose of Control 2 vaccine administered in Phase 2, at Day 1.	Combination Product: Control 2; Control 2 vaccine is administered intramuscularly in the non-dominant upper deltoid to participants in Control OA group from Phase 2, at Day 1.

Outcome Measures

Primary Outcome Measures :

1. Percentage of participants reporting each solicited administration site event [ Time Frame: From Day 1 to Day 7 ]
   The following administration site events will be solicited: pain, redness, swelling, lymphadenopathy (defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm).
2. Percentage of participants reporting each solicited systemic event [ Time Frame: From Day 1 to Day 7 ]
   The following systemic events will be solicited: fever, headache, myalgia, arthralgia, fatigue, chills. Fever is defined as temperature greater than or equal to (>=) 38 degree Celsius (°C)/100.4 degree Fahrenheit (°F) regardless the location of measurement. The route for measuring temperature can be oral, axillary or tympanic.
3. Percentage of participants reporting unsolicited adverse events (AEs) [ Time Frame: From Day 1 to Day 28 ]
   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.
4. Percentage of participants reporting serious adverse events (SAEs) [ Time Frame: From Day 1 to Day 183 ]
   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.
5. Percentage of participants reporting adverse events of special interest (AESIs) [ Time Frame: From Day 1 to Day 183 ]
   The following events are considered as AESI in this study: severe hypersensitivity reactions within 24 hours after study intervention administration, myocarditis/pericarditis and potential immune-mediated diseases (pIMDs).
6. Percentage of participants reporting medically attended events (MAEs) [ Time Frame: From Day 1 to Day 183 ]
   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).
7. Percentage of participants reporting a shift from a non-clinically significant laboratory value on Day 1 (pre-dose) to a clinically significant abnormal laboratory value on Day 8 (post-dose) and/or Day 29 (post-dose) for hematology and clinical chemistry [ Time Frame: From Day 1 (pre-dose) to Day 8 (post-dose) and/or Day 29 (post-dose) ]
   Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participants condition.
8. Geometric mean titer (GMT) of antigen 1 antibody titer [ Time Frame: At Day 29 ]
9. Geometric mean increase (GMI) of antigen 1 antibody titer [ Time Frame: From Day 1 to Day 29 ]
   GMI is defined as the geometric mean of the ratios of the post dosing titer over the Day 1 titer.
10. Percentage of participants with antigen 1 seroconversion rate (SCR) [ Time Frame: From Day 1 to Day 29 ]
11. Percentage of participants with antigen 1 titer >= cut off value [ Time Frame: At Day 1 and Day 29 ]
12. GMT of antigen 2 antibody titer [ Time Frame: At Day 29 ]
13. GMI of antigen 2 antibody titer [ Time Frame: From Day 1 to Day 29 ]
    GMI is defined as the geometric mean of the ratios of the post dosing titer over the Day 1 titer.
14. Percentage of participants with antigen 2 SCR [ Time Frame: From Day 1 to Day 29 ]

Secondary Outcome Measures :

1. GMT of antigen 1 antibody titer [ Time Frame: At Day 92 and Day 183 ]
2. GMI of antigen 1 antibody titer [ Time Frame: From Day 1 to Day 92 ]
   GMI is defined as the geometric mean of the ratios of the post dosing titer over the Day 1 titer.
3. GMI of antigen 1 antibody titer [ Time Frame: From Day 1 to Day 183 ]
   GMI is defined as the geometric mean of the ratios of the post dosing titer over the Day 1 titer.
4. Percentage of participants with antigen 1 titer >= cut off value [ Time Frame: At Day 183 ]
5. GMT of antigen 2 antibody titer [ Time Frame: At Day 92 and Day 183 ]
6. GMI of antigen 2 antibody titer [ Time Frame: From Day 1 to Day 92 ]
   GMI is defined as the geometric mean of the ratios of the post dosing titer over the Day 1 titer.
7. GMI of antigen 2 antibody titer [ Time Frame: From Day 1 to Day 183 ]
   GMI is defined as the geometric mean of the ratios of the post dosing titer over the Day 1 titer.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• A male or female between and including 18 and 50 years of age in Phase 1 and between and including 18 and 85 years of age (YA: 18-64; OA: 65-85) in Phase 2 at the time of the study intervention administration.
• Healthy participants or medically stable participants as established by medical history, clinical examination, and safety laboratory assessments. Participants with chronic medical conditions with or without specific treatment are allowed to participate in this study if considered by the investigator as medically stable. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during 3 months before enrollment.
• Body mass index (BMI) >=18 kilograms per meter square (kg/m^2) and less than or equal to (<=) 35 kg/m^2.
• Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
• Written informed consent obtained from the participant prior to performing any study-specific procedure.
• Female participants of non-childbearing potential may be enrolled in the study.
• Female participants of childbearing potential may be enrolled in the study if the participant:
• has practiced adequate contraception for 28 days prior to study intervention administration, and
• has a negative pregnancy test on the day of study intervention administration, and
• has agreed to continue adequate contraception for at least 1 month after study intervention administration

Exclusion Criteria:

Medical conditions

• Only in Phase 1: Any clinically significant* hematological, biochemical, urinalysis or (hemoglobin A1c) HbA1c laboratory abnormality.

  *The investigator should use the clinical judgment to decide which abnormalities are clinically significant.

• Participant tested positive for influenza by local health authority-approved testing methods within 180 days prior to Day 1.
• Current or past malignancy, unless completely resolved without clinically significant sequelae for >5 years.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection, based on medical history and physical examination (no laboratory testing required). However, in Phase 2, HIV-infected individuals may be enrolled if participants have been stable on antiretroviral therapy for the past 6 consecutive months, i.e., their treatment has not been modified, their cluster of differentiation 4 (CD4) cell count is >=200/cubic millimeter (mm^3) and their viral load has been undetectable (i.e., HIV-RNA less than (<) 50 copies/milliliter [mL]) (based on medical records, no laboratory testing required).
• History of myocarditis or pericarditis less than or equal to 10 years prior to vaccine administration, including a history of myocarditis or pericarditis following vaccination with an mRNA coronavirus disease 2019 (COVID-19) vaccine.
• Participants with history of hypersensitivity or severe allergic reaction to any previous vaccine or hypersensitivity likely to be exacerbated by any component of the study intervention (including latex, polyethylene glycol, egg protein and aminoglycoside antibiotics).
• History of, or uncontrolled neurological disorders or seizures, including Guillain-Barré syndrome and Bell's palsy, with the exception of febrile seizures during childhood.
• Any history of dementia or any medical condition that moderately or severely impairs cognition.
• Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
• Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.

Prior/Concomitant therapy

• Administration of an influenza vaccine (including any of the study investigational vaccines) within 180 days before enrollment or planned administration within 28 days (Day 29) after the study intervention administration.

• Phase 1: Administration of a vaccine not foreseen by the study protocol in the period starting 28 days (Day -28) before the study intervention administration or planned administration within 28 days (Day 29) after the study intervention administration. Phase 2: Administration of a vaccine not foreseen by the study protocol in the period starting 15 days (Day -15) before the study intervention administration or planned administration within 28 days (Day 29) after the study intervention administration.

  *In case emergency mass vaccination for an unforeseen public health threat is recommended and/or organized by public health authorities outside the routine immunization program, the time period described above can be reduced to 7 days if, necessary for that vaccine, provided it is used according to the local governmental recommendations and that the Sponsor is notified accordingly.

• Use of any investigational or non-registered product (drug, vaccine, or invasive medical device) other than the study intervention during the period beginning 30 days before the study intervention administration, or their planned use during the study period.
• Administration of long-acting immune-modifying drugs within 90 days before enrollment or planned use at any time during the study period.
• Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the study intervention administration, or planned administration during the study period. Administration of monoclonal antibodies specifically directed against the spike protein of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), for treatment of COVID-19 disease is allowed.
• Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the study intervention administration. For corticosteroids, this will mean prednisone equivalent >=20 milligrams (mg)/day. Inhaled, topical and intraarticular steroids are allowed.

Other exclusions

• Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/invasive medical device).
• Pregnant or lactating female.
• Bedridden participants.
• Female planning to become pregnant or planning to discontinue contraceptive precautions within the 1-month post-dosing period.
• Alcoholism or substance use disorder within the past 24 months based on the presence of 2 or more of the following abuse criteria: hazardous use, social/interpersonal problems related to use, neglect of major roles to use, withdrawal, tolerance, use of larger amounts or longer, repeated attempts to quit or control use, much time spent using, physical or psychological problems related to use, activities given up to use, craving.
• Any study personnel or their immediate dependents, family, or household members.
• Participants with extensive tattoos covering deltoid region on both arms that would preclude the assessment of local reactogenicity.

Contacts and Locations

Locations

United States, Colorado

GSK Investigational Site

Englewood, Colorado, United States, 80110

United States, Florida

GSK Investigational Site

Hialeah, Florida, United States, 33012

GSK Investigational Site

Miami, Florida, United States, 33147

GSK Investigational Site

Miami, Florida, United States, 33186

United States, Illinois

GSK Investigational Site

Chicago, Illinois, United States, 60640

United States, Indiana

GSK Investigational Site

Valparaiso, Indiana, United States, 46383

United States, Kansas

GSK Investigational Site

Lenexa, Kansas, United States, 66219

GSK Investigational Site

Wichita, Kansas, United States, 67207

United States, Kentucky

GSK Investigational Site

Lexington, Kentucky, United States, 40509

United States, Massachusetts

GSK Investigational Site

Boston, Massachusetts, United States, 02215

United States, Michigan

GSK Investigational Site

Dearborn Heights, Michigan, United States, 48127

GSK Investigational Site

Southfield, Michigan, United States, 48076

United States, Nebraska

GSK Investigational Site

Papillion, Nebraska, United States, 68046

United States, New York

GSK Investigational Site

East Syracuse, New York, United States, 13057

GSK Investigational Site

Rochester, New York, United States, 14609

United States, North Carolina

GSK Investigational Site

Greensboro, North Carolina, United States, 27408

GSK Investigational Site

Raleigh, North Carolina, United States, 27612

GSK Investigational Site

Wilmington, North Carolina, United States, 28401

United States, Rhode Island

GSK Investigational Site

East Greenwich, Rhode Island, United States, 02818

United States, Tennessee

GSK Investigational Site

Knoxville, Tennessee, United States, 37909

United States, Texas

GSK Investigational Site

Fort Worth, Texas, United States, 76135

GSK Investigational Site

Tomball, Texas, United States, 77375

United States, Virginia

GSK Investigational Site

Newport News, Virginia, United States, 23606

GSK Investigational Site

Norfolk, Virginia, United States, 23502

Belgium

GSK Investigational Site

Antwerpen, Belgium, 2000

GSK Investigational Site

Gent, Belgium, 9000

GSK Investigational Site

Ieper, Belgium, 8900

GSK Investigational Site

Kluisbergen, Belgium, 9690

GSK Investigational Site

Mechelen, Belgium, 2800

GSK Investigational Site

Tielt, Belgium

GSK Investigational Site

Wilrijk, Belgium, 2610

GSK Investigational Site

Zwalm, Belgium, 9630

Canada, Nova Scotia

GSK Investigational Site

Halifax, Nova Scotia, Canada, B3K 6R8

Canada, Quebec

GSK Investigational Site

Chicoutimi, Quebec, Canada, G7H 7Y8

GSK Investigational Site

Sherbrooke, Quebec, Canada, J1L 0H8

Canada

GSK Investigational Site

Quebec, Canada, G1W 4R4

GSK Investigational Site

Truro, Canada, B2N 1L2

South Africa

GSK Investigational Site

Johannesburg, Gauteng, South Africa, 1632

GSK Investigational Site

Johannesburg, Gauteng, South Africa, 2113

GSK Investigational Site

Bellville, South Africa, 7530

GSK Investigational Site

East London, South Africa, 5201

Sponsors and Collaborators

GlaxoSmithKline

CureVac

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

More Information

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT05823974
• Other Study ID Numbers: 217884; 2022-502308-66-00 ( Other Identifier: EU CT Number )
• First Posted: April 21, 2023
• Last Update Posted: March 1, 2024
• Last Verified: February 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan 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/
• Supporting Materials: 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.
• URL: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by GlaxoSmithKline:

Influenza; Safety; Reactogenicity; Immunogenicity; mRNA vaccine; Healthy younger adults; Healthy older adults

Additional relevant MeSH terms:

Influenza, Human; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases