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
Study complete
Study complete
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
    Primary completion date:
    2024-27-12
    Observational study model:
    Not applicable
    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
    2

    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
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    Location
    GSK Investigational Site
    El Dorado, KS, United States, 67042
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Greensboro, NC, United States, 27408
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Hialeah, FL, United States, 33012
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Knoxville, TN, United States, 37909
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Lenexa, KS, United States, 66219
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Lexington, KY, United States, 40509
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Miami, FL, United States, 33147
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Miami, FL, United States, 33186
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Norfolk, VA, United States, 23502
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tomball, TX, United States, 77375
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Valparaiso, IN, United States, 46383
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Austin, TX, United States, 78705
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Chicago, IL, United States, 60640
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Fort Worth, TX, United States, 76135
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Newport News, VA, United States, 23606
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Newton, KS, United States, 67114
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Rochester, NY, United States, 14609
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Wichita, KS, United States, 67207
    Status
    Study Complete
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    Location
    GSK Investigational Site
    East Greenwich, RI, United States, 02818
    Status
    Terminated/Withdrawn
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    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
    Study complete
    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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