Last updated: 03/10/2026 12:10:25

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

GSK study ID

222853

See study documents

Clinicaltrials.gov ID

NCT06431607

See results summary

EudraCT ID

Not applicable

EU CT Number

Not applicable

Trial status

Completed

Overview

Eligibility

Locations

Study documents

Results summary

Plain language summaries

Additional information

Trial overview

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

Trial description: 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).

Primary purpose:

Prevention

Trial design:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Allocation:

Randomized

Primary outcomes:

Part 1 YA: Geometric mean titer (GMT) of antigen 1 antibody titer

Timeframe: At Day 29

Part 2 YA: GMT of antigen 1 antibody titer

Timeframe: At Day 29

Part 1 OA: GMT of antigen 1 antibody titer

Timeframe: At Day 29

Part 2 OA: GMT of antigen 1 antibody titer

Timeframe: At Day 29

Part 1 YA: Geometric mean increase (GMI) of antigen 1 antibody titers

Timeframe: From Day 1 (baseline) to Day 29

Part 2 YA: GMI of antigen 1 antibody titers

Timeframe: From Day 1 (baseline) to Day 29

Part 1 OA: GMI of antigen 1 antibody titers

Timeframe: From Day 1 (baseline) to Day 29

Part 2 OA: GMI of antigen 1 antibody titers

Timeframe: From Day 1 (baseline) to Day 29

Part 1 YA: Percentage of participants with antigen 1 antibody seroconversion rate (SCR)

Timeframe: From Day 1 (baseline) to Day 29

Part 2 YA: Percentage of participants with antigen 1 antibody SCR

Timeframe: From Day 1 (baseline) to Day 29

Part 1 OA: Percentage of participants with antigen 1 antibody SCR

Timeframe: From Day 1 (baseline) to Day 29

Part 2 OA: Percentage of participants with antigen 1 antibody SCR

Timeframe: From Day 1 (baseline) to Day 29

Part 1 YA: Percentage of participants with antigen 1 antibody seroprotection rate (SPR)

Timeframe: At Day 1

Part 2 YA: Percentage of participants with antigen 1 antibody SPR

Timeframe: At Day 1

Part 1 OA: Percentage of participants with antigen 1 antibody SPR

Timeframe: At Day 1

Part 2 OA: Percentage of participants with antigen 1 antibody SPR

Timeframe: At Day 1

Part 1 YA: Percentage of participants with antigen 1 antibody SPR

Timeframe: At Day 29

Part 2 YA: Percentage of participants with antigen 1 antibody SPR

Timeframe: At Day 29

Part 1 OA: Percentage of participants with antigen 1 antibody SPR

Timeframe: At Day 29

Part 2 OA: Percentage of participants with antigen 1 antibody SPR

Timeframe: At Day 29

Secondary outcomes:

Part 1 YA: GMT of antigen 2 antibody titer

Timeframe: At Day 29

Part 2 YA: GMT of antigen 2 antibody titer

Timeframe: At Day 29

Part 1 OA: GMT of antigen 2 antibody titer

Timeframe: At Day 29

Part 2 OA: GMT of antigen 2 antibody titer

Timeframe: At Day 29

Part 1 YA: GMI of antigen 2 antibody titer

Timeframe: From Day 1 (baseline) to Day 29

Part 2 YA: GMI of antigen 2 antibody titer

Timeframe: From Day 1 (baseline) to Day 29

Part 1 OA: GMI of antigen 2 antibody titer

Timeframe: From Day 1 (baseline) to Day 29

Part 2 OA: GMI of antigen 2 antibody titer

Timeframe: From Day 1 (baseline) to Day 29

Part 1 YA: Percentage of participants with antigen 2 antibody SCR

Timeframe: From Day 1 (baseline) to Day 29

Part 2 YA: Percentage of participants with antigen 2 antibody SCR

Timeframe: From Day 1 (baseline) to Day 29

Part 1 OA: Percentage of participants with antigen 2 antibody SCR

Timeframe: From Day 1 (baseline) to Day 29

Part 2 OA: Percentage of participants with antigen 2 antibody SCR

Timeframe: From Day 1 (baseline) to Day 29

Part 1 YA: Number of participants reporting any solicited administration site adverse events (AEs)

Timeframe: Day 1 to Day 7

Part 2 YA: Number of participants reporting any solicited administration site AEs

Timeframe: Day 1 to Day 7

Part 1 OA: Number of participants reporting any solicited administration site AEs

Timeframe: Day 1 to Day 7

Part 2 OA: Number of participants reporting any solicited administration site AEs

Timeframe: Day 1 to Day 7

Part 1 YA: Number of participants reporting any solicited systemic AEs

Timeframe: Day 1 to Day 7

Part 2 YA: Number of participants reporting any solicited systemic AEs

Timeframe: Day 1 to Day 7

Part 1 OA: Number of participants reporting any solicited systemic AEs

Timeframe: Day 1 to Day 7

Part 2 OA: Number of participants reporting any solicited systemic AEs

Timeframe: Day 1 to Day 7

Part 1 YA: Number of participants reporting any unsolicited AEs

Timeframe: Day 1 to Day 28

Part 2 YA: Number of participants reporting any unsolicited AEs

Timeframe: Day 1 to Day 28

Part 1 OA: Number of participants reporting any unsolicited AEs

Timeframe: Day 1 to Day 28

Part 2 OA: Number of participants reporting any unsolicited AEs

Timeframe: Day 1 to Day 28

Part 1 YA: Number of participants reporting serious adverse events (SAEs)

Timeframe: Day 1 to Day 183

Part 2 YA: Number of participants reporting SAEs

Timeframe: Day 1 to Day 183

Part 1 OA: Number of participants reporting SAEs

Timeframe: Day 1 to Day 183

Part 2 OA: Number of participants reporting SAEs

Timeframe: Day 1 to Day 183

Part 1 YA: Number of participants reporting AEs of special interest (AESIs)

Timeframe: Day 1 to Day 183

Part 2 YA: Number of participants reporting AESIs

Timeframe: Day 1 to Day 183

Part 1 OA: Number of participants reporting AESIs

Timeframe: Day 1 to Day 183

Part 2 OA: Number of participants reporting AESIs

Timeframe: Day 1 to Day 183

Part 1 YA: Number of participants reporting medically attended adverse events (MAAEs)

Timeframe: Day 1 to Day 183

Part 2 YA: Number of participants reporting MAAEs

Timeframe: Day 1 to Day 183

Part 1 OA: Number of participants reporting MAAEs

Timeframe: Day 1 to Day 183

Part 2 OA: Number of participants reporting MAAEs

Timeframe: Day 1 to Day 183

Interventions:

Biological/vaccine: F2G22B/DL001Z

Biological/vaccine: F2H23D/DL001Z-NH

Biological/vaccine: F2H23B/DL001Z-NH

Biological/vaccine: F2H23H/DL001Z

Combination product: FDQ23A-NH (Flu D-QIV)

Biological/vaccine: GSK5800544A

Combination product: Flu D-TIV

Biological/vaccine: F2H23A/DL001Z-NH

Biological/vaccine: F2H23G/DL001Z

Combination product: Fluzone HD Quadrivalent

Combination product: Fluzone HD

Enrollment:

845

Observational study model:

Not applicable

Primary completion date:

2024-27-12

Time perspective:

Not applicable

Clinical publications:

Not applicable

Medical condition

Influenza, Human

Product

Not applicable

Collaborators

Not applicable

Study date(s)

May 2024 to June 2025

Type

Interventional

Phase

Participation criteria

Sex

Female & Male

Age

18 - 85 Years

Accepts healthy volunteers

Yes

1. 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.
2. 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.

1. Participant tested positive for influenza by local health authority-approved testing methods within 180 days prior to Day 1.
2. 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).

Inclusion and exclusion criteria

Inclusion criteria:

1. 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. 2. 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. 3. Body mass index (BMI) >=18 Kilograms per meter square (kg/m²) and less than or equal to (<=) 35kg/m2. 4. 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. 5. Written informed consent obtained from the participant prior to performance of any study-specific procedure. 6. Female participants of non-childbearing potential may be enrolled in the clinical study. 7. 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:

1. Participant tested positive for influenza by local health authority-approved testing methods within 180 days prior to Day 1. 2. 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). 3. 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). 4. 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. 5. 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). 6. Hypersensitivity to latex. 7. Recurrent history or uncontrolled neurological disorders or seizures, including Guillain-Barré syndrome and Bell’s palsy, with the exception of febrile seizures during childhood. 8. Any history of dementia or any medical condition that moderately or severely impairs cognition. 9. Any condition that in the judgment of the investigator would make intramuscular injection unsafe. 10. 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. 11. Administration of an influenza vaccine within 180 days before enrollment or planned administration prior to Visit 2 (Day 29) after the study intervention administration. 12. Previous vaccination with a mRNA influenza vaccine. 13. 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. 14. 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. 15. 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. 16. 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. 17. 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). 18. Pregnant or lactating female participant. 19. Bedridden participants. 20. Female participant planning to become pregnant or planning to discontinue contraceptive precautions within the 1-month post-dosing period. 21. 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. 22. Any study personnel or their immediate dependents, family, or household members. 23. Participants with extensive tattoos covering deltoid region on both arms that would preclude the assessment of local reactogenicity.

Trial location(s)

Location

Status

Location

GSK Investigational Site

El Dorado, KS, United States, 67042

Status

Study Complete

Location

GSK Investigational Site

Greensboro, NC, United States, 27408

Status

Study Complete

Location

GSK Investigational Site

Hialeah, FL, United States, 33012

Status

Study Complete

Location

GSK Investigational Site

Knoxville, TN, United States, 37909

Status

Study Complete

Location

GSK Investigational Site

Lenexa, KS, United States, 66219

Status

Study Complete

Location

GSK Investigational Site

Lexington, KY, United States, 40509

Status

Study Complete

Location

GSK Investigational Site

Miami, FL, United States, 33147

Status

Study Complete

Location

GSK Investigational Site

Miami, FL, United States, 33186

Status

Study Complete

Location

GSK Investigational Site

Norfolk, VA, United States, 23502

Status

Study Complete

Location

GSK Investigational Site

Tomball, TX, United States, 77375

Status

Study Complete

Location

GSK Investigational Site

Valparaiso, IN, United States, 46383

Status

Study Complete

Location

GSK Investigational Site

Austin, TX, United States, 78705

Status

Study Complete

Location

GSK Investigational Site

Chicago, IL, United States, 60640

Status

Study Complete

Location

GSK Investigational Site

Fort Worth, TX, United States, 76135

Status

Study Complete

Location

GSK Investigational Site

Newport News, VA, United States, 23606

Status

Study Complete

Location

GSK Investigational Site

Newton, KS, United States, 67114

Status

Study Complete

Location

GSK Investigational Site

Rochester, NY, United States, 14609

Status

Study Complete

Location

GSK Investigational Site

Wichita, KS, United States, 67207

Status

Study Complete

Location

GSK Investigational Site

East Greenwich, RI, United States, 02818

Status

Terminated/Withdrawn

Study documents

Protocol

Available language(s): English

Download document(s)

Statistical analysis plan

Available language(s): English

Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status

Completed

Actual primary completion date

2024-27-12

Actual study completion date

2025-04-06

Plain language summaries

Summary of results in plain language

Available language(s): English, Spanish (United States)

Download document(s)

To view plain language summaries on trialsummaries.com click here.

Additional information about the trial

Additional information

Not applicable

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Access to clinical trial data by researchers

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