Influenza, HumanPhase 1/2NCT05823974
A Study to Assess the Safety and Immune Response of a Vaccine Against Influenza in Healthy Younger and Older Adults
A Phase 1/2 study testing F2C22C/DL001Z, F2B22A/DL001Z and F2B22B/DL001Z in people with Influenza, Human, run by GlaxoSmithKline at 41 sites in 4 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human
- What is being tested?
- F2C22C/DL001Z, F2B22A/DL001Z and F2B22B/DL001Z
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,275 participants
- Where
- 41 sitesin 4 countries
- Study dates
- 27 Apr 2023to 18 Dec 2024
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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).
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- 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.
Trial locations and contacts
41 sites in 4 countries.
41 sites in 4 countries
United States24 sites
GSK Investigational Site
Boston, Massachusetts, 02215
GSK Investigational Site
Chicago, Illinois, 60640
GSK Investigational Site
Dayton, Ohio, 33147
GSK Investigational Site
Dearborn, Michigan, 48127
GSK Investigational Site
Denver, North Carolina, 80110
GSK Investigational Site
East Greenwich, Rhode Island, 02818
GSK Investigational Site
Fort Worth, Texas, 76135
GSK Investigational Site
Greensboro, North Carolina, 27408
GSK Investigational Site
Hialeah, Florida, 33012
GSK Investigational Site
Houston, Texas, 48076
GSK Investigational Site
Knoxville, Tennessee, 37909
GSK Investigational Site
Lenexa, Kansas, 66219
GSK Investigational Site
Lexington, Kentucky, 40509
GSK Investigational Site
Miami, Florida, 33186
GSK Investigational Site
Newport News, Virginia, 23606
GSK Investigational Site
Norfolk, Virginia, 23502
GSK Investigational Site
Papillion, Nebraska, 68046
GSK Investigational Site
Raleigh, North Carolina, 27612
GSK Investigational Site
Rochester, New York, 14609
GSK Investigational Site
Syracuse, New York, 13057
GSK Investigational Site
Tomball, Texas, 77375
GSK Investigational Site
Valparaiso, Indiana, 46383
GSK Investigational Site
Wichita, Kansas, 67207
GSK Investigational Site
Wilmington, North Carolina, 28401
Belgium8 sites
GSK Investigational Site
Antwerp, 2000
GSK Investigational Site
Edegem, 2610
GSK Investigational Site
Ghent, 9000
GSK Investigational Site
Ieper, 8900
GSK Investigational Site
Kluisbergen, 9690
GSK Investigational Site
Mechelen, 2800
GSK Investigational Site
Tielt
GSK Investigational Site
Zwalm, 9630
Canada5 sites
GSK Investigational Site
Chicoutimi, Quebec, G7H 7Y8
GSK Investigational Site
Halifax, Nova Scotia, B3K 6R8
GSK Investigational Site
Québec, Quebec, G1W 4R4
GSK Investigational Site
Sherbrooke, Quebec, J1L 0H8
GSK Investigational Site
Truro, Nova Scotia, B2N 1L2
South Africa4 sites
GSK Investigational Site
Buffalo, 5201
GSK Investigational Site
Cape Town, 7530
GSK Investigational Site
Johannesburg, 2113
GSK Investigational Site
Tembisa, 1632
About this study
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
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).
- Conditions
- Influenza, Human
- Being tested
- F2C22C/DL001Z, F2B22A/DL001Z, F2B22B/DL001Z, F2B22C/DL001Z, F2B22D/DL001Z
- Keywords
- Influenza, Safety, Reactogenicity, Immunogenicity, mRNA vaccine, Healthy younger adults, Healthy older adults
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F2C22C/DL001ZBiological
Study intervention was administered intramuscularly in Phase 1, at Day 1.
F2B22A/DL001ZBiological
Study intervention was administered intramuscularly in Phase 1, at Day 1.
F2B22B/DL001ZBiological
Study intervention was administered intramuscularly in Phase 1, at Day 1.
F2B22C/DL001ZBiological
Study intervention was administered intramuscularly in Phase 1, at Day 1.
F2B22D/DL001ZBiological
Study intervention was administered intramuscularly in Phase 1, at Day 1.
F2B22E/DL001ZBiological
Study intervention was administered intramuscularly in Phase 1, at Day 1.
F2F22A/DL001ZBiological
Study intervention was administered intramuscularly in Phase 1, at Day 1.
F2F22B/DL001ZBiological
Study intervention was administered intramuscularly in Phase 1, at Day 1.
F2F22C/DL001ZBiological
Study intervention was administered intramuscularly in Phase 1, at Day 1.
F2F22D/DL001ZBiological
Study intervention was administered intramuscularly in Phase 1, at Day 1.
F2F22E/DL001ZBiological
Study intervention was administered intramuscularly in Phase 1, at Day 1.
Control 1Combination product
Control vaccine was administered intramuscularly in Phase 1, at Day 1.
F2F23D/DL001Z-NHBiological
Study intervention was administered intramuscularly in Phase 2, at Day 1.
F2F23A/DL001Z-NHBiological
Study intervention was administered intramuscularly in Phase 2, at Day 1.
F2F23B/DL001Z-NHBiological
Study intervention was administered intramuscularly in Phase 2, at Day 1.
Control 2Combination product
Control vaccine was administered intramuscularly in Phase 2, at Day 1.
F2F23C/DL001Z-NHBiological
Study intervention was administered intramuscularly in Phase 2, at Day 1.
Control 3Combination product
Control vaccine was administered intramuscularly in Phase 2, at Day 1.
F2F22F/DL001ZBiological
Study intervention was administered intramuscularly in Phase 1, at Day 1.
| Study group | Role | What they receive |
|---|---|---|
| Flu mRNA_Ph1_1 Younger Adults (YA) Group | Experimental | YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1. Receives: Biological: F2C22C/DL001Z |
| Flu mRNA_Ph1_2 YA Group | Experimental | YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1. Receives: Biological: F2B22A/DL001Z |
| Flu mRNA_Ph1_3 YA Group | Experimental | YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1. Receives: Biological: F2B22B/DL001Z |
| Flu mRNA_Ph1_4 YA Group | Experimental | YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1. Receives: Biological: F2B22C/DL001Z |
| Flu mRNA_Ph1_5 YA Group | Experimental | YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1. Receives: Biological: F2B22D/DL001Z |
| Flu mRNA_Ph1_6 YA Group | Experimental | YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1. Receives: Biological: F2B22E/DL001Z |
| Flu mRNA_Ph1_7 YA Group | Experimental | YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1. Receives: Biological: F2F22A/DL001Z |
| Flu mRNA_Ph1_8 YA Group | Experimental | YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1. Receives: Biological: F2F22B/DL001Z |
| Flu mRNA_Ph1_9 YA Group | Experimental | YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1. Receives: Biological: F2F22C/DL001Z |
| Flu mRNA_Ph1_10 YA Group | Experimental | YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1. Receives: Biological: F2F22D/DL001Z |
| Flu mRNA_Ph1_11 YA Group | Experimental | YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1. Receives: Biological: F2F22E/DL001Z |
| Flu mRNA_Ph1_12 YA Group | Experimental | YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1. Receives: Biological: F2F22F/DL001Z |
| Control Ph1_YA Group | Active comparator | YA participants received a single dose of Control 1 administered in Phase 1, at Day 1. Receives: Combination Product: Control 1 |
| Flu mRNA_Ph2_1_YA Group | Experimental | YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1. Receives: Biological: F2F23D/DL001Z-NH |
| Flu mRNA_Ph2_2_YA Group | Experimental | YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1. Receives: Biological: F2F23A/DL001Z-NH |
| Flu mRNA_Ph2_3_YA Group | Experimental | YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1. Receives: Biological: F2F23B/DL001Z-NH |
| Control_Ph2_YA Group | Active comparator | YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1. Receives: Combination Product: Control 2 |
| Flu mRNA_Ph2_1_Older adults (OA) Group | Experimental | OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1. Receives: Biological: F2F23A/DL001Z-NH |
| Flu mRNA_Ph2_2_OA Group | Experimental | OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1. Receives: Biological: F2F23B/DL001Z-NH |
| Flu mRNA_Ph2_3_OA Group | Experimental | OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1. Receives: Biological: F2F23C/DL001Z-NH |
| Control_Ph2_OA Group | Active comparator | OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1. Receives: Combination Product: Control 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs)
Assessed solicited administration site events included pain, redness (Erythema), swelling, lymphadenopathy (defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm). Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.
Measured: Day 1 to Day 7
Number of Participants Reporting Any Solicited Systemic AEs
Assessed solicited systemic events included fever (defined as axillary temperature greater than or equal to (>=) 38.0°C/100.4°F), chills, headache, fatigue, myalgia, and arthralgia. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.
Measured: Day 1 to Day 7
Number of Participants Reporting Any Unsolicited AEs
An unsolicited AE is defined as an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow up for solicited events. Unsolicited AEs include both serious and non-serious AEs. Any = occurrence the event regardless of intensity grade or relation to the study vaccination.
Measured: Day 1 to Day 28
Number of Participants Reporting Serious Adverse Events (SAEs)
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, is an abnormal pregnancy outcome, or is a suspected transmission of any infectious agent via an authorized medicinal product. Any = occurrence the event regardless of intensity grade or relation to the study vaccination.
Measured: Day 1 to Day 183
Number of Participants Reporting AEs of Special Interest (AESIs)
The following events were considered as AESI in this study: severe hypersensitivity reactions within 24 hours after study intervention administration, myocarditis/pericarditis and potential immune-mediated diseases (pIMDs). Any = occurrence the event regardless of intensity grade or relation to the study vaccination.
Measured: Day 1 to Day 183
Number of Participants Reporting Medically Attended Events (MAEs)
MAE is defined as an AE that results in an unscheduled visit to a medical professional (e.g., physician's office visits, emergency room visits or hospitalization). Any = occurrence the event regardless of intensity grade or relation to the study vaccination.
Measured: Day 1 to Day 183
Number of Participants Reporting a Shift From Abnormal Non-clinically Significant and Normal or Missing Laboratory Value on Day 1 to Clinically Significant Abnormal Laboratory Value on Day 8 for Hematology, and Clinical Chemistry
Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participants condition. Normal or missing values refer to laboratory values that were within normal range or missing at baseline.
Measured: At Day 8 compared to baseline (Day 1)
Number of Participants Reporting a Shift From Abnormal Non-clinically Significant and Normal or Missing Laboratory Value on Day 1 to Clinically Significant Abnormal Laboratory Value on Day 29 for Hematology, and Clinical Chemistry
Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participants condition. Normal or missing values refer to laboratory values that were within normal range or missing at baseline.
Measured: At Day 29 compared to baseline (Day 1)
Geometric Mean Titer (GMT) of Antigen 1 Antibody Titer
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Measured: At Day 29
Geometric Mean Increase (GMI) of Antigen 1 Antibody Titers From Day 1 to Day 29
GMI is defined as the geometric mean of the ratios of the post dosing titer over the Day 1 titer. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Measured: From Day 1 (baseline) to Day 29
Percentage of Participants With Antigen 1 Antibody Seroconversion Rate (SCR)
SCR is defined as the percentage of dosed participants who have either an anti-vaccine antibody pre-dose titer < 1:10 and a post-dose anti-vaccine antibody titer >= 1:40 or a pre-dose anti-vaccine antibody titer >= 1:10 and at least a 4-fold increase in post-dose anti-vaccine antibody titer. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Measured: From Day 1 to Day 29
Percentage of Participants With Antigen 1 Antibody Seroprotection Rate (SPR)
SPR is defined as the percentage of dosed participants with a anti-vaccine antibody titer >= 1:40. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Measured: At Day 1
Percentage of Participants With Antigen 1 Antibody SPR
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Measured: At Day 29
GMT of Antigen 2 Antibody Titer
Measured: At Day 29
GMI of Antigen 2 Antibody Titer From Day 1 to Day 29
Measured: From Day 1 (baseline) to Day 29
Percentage of Participants With Antigen 2 Antibody SCR
Measured: From Day 1 to Day 29
Secondary outcomes (7)
GMT of Antigen 1 Antibody Titer
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Measured: At Day 92
GMT of Antigen 1 Antibody Titer
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Measured: At Day 183
GMI of Antigen 1 Antibody Titer From Day 1 to Day 92
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Measured: From Day 1 (baseline) to Day 92
GMI of Antigen 1 Antibody Titer From Day 1 to Day 183
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Measured: From Day 1 (baseline) to Day 183
Percentage of Participants With Antigen 1 Antibody SPR
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Measured: At Day 183
GMT of Antigen 2 Antibody Titer
Measured: At Day 92 and Day 183
GMI of Antigen 2 Antibody Titer
Measured: From Day 1 to Day 92 and Day 1 to Day 183
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start27 Apr 2023
- Primary completion2 Jul 2024
- Study completion18 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Influenza, HumanStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,275 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CureVac
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05823974
- Sponsor's protocol ID
- 217884
- Other IDs
- 2022-502308-66-00
- Status last verified
- Jun 2025
- First submitted
- 11 Apr 2023
- Last updated
- 23 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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/
Publications
De Coster I, Cardona JF, Ferguson M, Leroux-Roels I, Nell H, Berre S, Schoonbroodt S, Lorin C, Ovbude LJ, Moldt B; FLU SV mRNA-002 study group. A Phase 1/2 Trial Evaluating the Safety and Immunogenicity of an mRNA-based Seasonal Influenza Vaccine Candidate Encoding Hemagglutinin and Neuraminidase. Infect Dis Ther. 2026 Oct 15. doi: 10.1007/s40121-026-01463-9. Online ahead of print.
PubMed 42875683
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05823974
- Acronym / sponsor ID
- 217884
- Conditions
- Influenza, Human
- Keywords
- Influenza, Safety, Reactogenicity, Immunogenicity, mRNA vaccine, Healthy younger adults, Healthy older adults
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,275 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- CureVac
- Study start
- 27 Apr 2023 (actual)
- Primary completion
- 2 Jul 2024 (actual)
- Study completion
- 18 Dec 2024 (actual)
- First posted
- 21 Apr 2023 (actual)
- Results
- Posted 23 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 21
| Arm | Type | Receives |
|---|---|---|
| Flu mRNA_Ph1_1 Younger Adults (YA) Group | Experimental | Biological: F2C22C/DL001ZYA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1. |
| Flu mRNA_Ph1_2 YA Group | Experimental | Biological: F2B22A/DL001ZYA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1. |
| Flu mRNA_Ph1_3 YA Group | Experimental | Biological: F2B22B/DL001ZYA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1. |
| Flu mRNA_Ph1_4 YA Group | Experimental | Biological: F2B22C/DL001ZYA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1. |
| Flu mRNA_Ph1_5 YA Group | Experimental | Biological: F2B22D/DL001ZYA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1. |
| Flu mRNA_Ph1_6 YA Group | Experimental | Biological: F2B22E/DL001ZYA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1. |
| Flu mRNA_Ph1_7 YA Group | Experimental | Biological: F2F22A/DL001ZYA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1. |
| Flu mRNA_Ph1_8 YA Group | Experimental | Biological: F2F22B/DL001ZYA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1. |
| Flu mRNA_Ph1_9 YA Group | Experimental | Biological: F2F22C/DL001ZYA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1. |
| Flu mRNA_Ph1_10 YA Group | Experimental | Biological: F2F22D/DL001ZYA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1. |
| Flu mRNA_Ph1_11 YA Group | Experimental | Biological: F2F22E/DL001ZYA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1. |
| Flu mRNA_Ph1_12 YA Group | Experimental | Biological: F2F22F/DL001ZYA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1. |
| Control Ph1_YA Group | Active comparator | Combination Product: Control 1YA participants received a single dose of Control 1 administered in Phase 1, at Day 1. |
| Flu mRNA_Ph2_1_YA Group | Experimental | Biological: F2F23D/DL001Z-NHYA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1. |
| Flu mRNA_Ph2_2_YA Group | Experimental | Biological: F2F23A/DL001Z-NHYA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1. |
| Flu mRNA_Ph2_3_YA Group | Experimental | Biological: F2F23B/DL001Z-NHYA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1. |
| Control_Ph2_YA Group | Active comparator | Combination Product: Control 2YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1. |
| Flu mRNA_Ph2_1_Older adults (OA) Group | Experimental | Biological: F2F23A/DL001Z-NHOA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1. |
| Flu mRNA_Ph2_2_OA Group | Experimental | Biological: F2F23B/DL001Z-NHOA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1. |
| Flu mRNA_Ph2_3_OA Group | Experimental | Biological: F2F23C/DL001Z-NHOA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1. |
| Control_Ph2_OA Group | Active comparator | Combination Product: Control 3OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (28 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| F2C22C/DL001ZStudy intervention was administered intramuscularly in Phase 1, at Day 1. | Biological | Flu mRNA_Ph1_1 Younger Adults (YA) Group |
| F2B22A/DL001ZStudy intervention was administered intramuscularly in Phase 1, at Day 1. | Biological | Flu mRNA_Ph1_2 YA Group |
| F2B22B/DL001ZStudy intervention was administered intramuscularly in Phase 1, at Day 1. | Biological | Flu mRNA_Ph1_3 YA Group |
| F2B22C/DL001ZStudy intervention was administered intramuscularly in Phase 1, at Day 1. | Biological | Flu mRNA_Ph1_4 YA Group |
| F2B22D/DL001ZStudy intervention was administered intramuscularly in Phase 1, at Day 1. | Biological | Flu mRNA_Ph1_5 YA Group |
| F2B22E/DL001ZStudy intervention was administered intramuscularly in Phase 1, at Day 1. | Biological | Flu mRNA_Ph1_6 YA Group |
| F2F22A/DL001ZStudy intervention was administered intramuscularly in Phase 1, at Day 1. | Biological | Flu mRNA_Ph1_7 YA Group |
| F2F22B/DL001ZStudy intervention was administered intramuscularly in Phase 1, at Day 1. | Biological | Flu mRNA_Ph1_8 YA Group |
| F2F22C/DL001ZStudy intervention was administered intramuscularly in Phase 1, at Day 1. | Biological | Flu mRNA_Ph1_9 YA Group |
| F2F22D/DL001ZStudy intervention was administered intramuscularly in Phase 1, at Day 1. | Biological | Flu mRNA_Ph1_10 YA Group |
| F2F22E/DL001ZStudy intervention was administered intramuscularly in Phase 1, at Day 1. | Biological | Flu mRNA_Ph1_11 YA Group |
| Control 1Control vaccine was administered intramuscularly in Phase 1, at Day 1. | Combination product | Control Ph1_YA Group |
| F2F23D/DL001Z-NHStudy intervention was administered intramuscularly in Phase 2, at Day 1. | Biological | Flu mRNA_Ph2_1_YA Group |
| F2F23A/DL001Z-NHStudy intervention was administered intramuscularly in Phase 2, at Day 1. | Biological | Flu mRNA_Ph2_1_Older adults (OA) Group, Flu mRNA_Ph2_2_YA Group |
| F2F23B/DL001Z-NHStudy intervention was administered intramuscularly in Phase 2, at Day 1. | Biological | Flu mRNA_Ph2_2_OA Group, Flu mRNA_Ph2_3_YA Group |
| Control 2Control vaccine was administered intramuscularly in Phase 2, at Day 1. | Combination product | Control_Ph2_YA Group |
| F2F23C/DL001Z-NHStudy intervention was administered intramuscularly in Phase 2, at Day 1. | Biological | Flu mRNA_Ph2_3_OA Group |
| Control 3Control vaccine was administered intramuscularly in Phase 2, at Day 1. | Combination product | Control_Ph2_OA Group |
| F2F22F/DL001ZStudy intervention was administered intramuscularly in Phase 1, at Day 1. | Biological | Flu mRNA_Ph1_12 YA Group |
Primary outcome
Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs)
Time frame: Day 1 to Day 7
Assessed solicited administration site events included pain, redness (Erythema), swelling, lymphadenopathy (defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm). Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.
Number of Participants Reporting Any Solicited Systemic AEs
Time frame: Day 1 to Day 7
Assessed solicited systemic events included fever (defined as axillary temperature greater than or equal to (>=) 38.0°C/100.4°F), chills, headache, fatigue, myalgia, and arthralgia. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.
Number of Participants Reporting Any Unsolicited AEs
Time frame: 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. Any = occurrence the event regardless of intensity grade or relation to the study vaccination.
Number of Participants Reporting Serious Adverse Events (SAEs)
Time frame: 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. Any = occurrence the event regardless of intensity grade or relation to the study vaccination.
Number of Participants Reporting AEs of Special Interest (AESIs)
Time frame: Day 1 to Day 183
The following events were considered as AESI in this study: severe hypersensitivity reactions within 24 hours after study intervention administration, myocarditis/pericarditis and potential immune-mediated diseases (pIMDs). Any = occurrence the event regardless of intensity grade or relation to the study vaccination.
Number of Participants Reporting Medically Attended Events (MAEs)
Time frame: 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). Any = occurrence the event regardless of intensity grade or relation to the study vaccination.
Number of Participants Reporting a Shift From Abnormal Non-clinically Significant and Normal or Missing Laboratory Value on Day 1 to Clinically Significant Abnormal Laboratory Value on Day 8 for Hematology, and Clinical Chemistry
Time frame: At Day 8 compared to baseline (Day 1)
Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participants condition. Normal or missing values refer to laboratory values that were within normal range or missing at baseline.
Number of Participants Reporting a Shift From Abnormal Non-clinically Significant and Normal or Missing Laboratory Value on Day 1 to Clinically Significant Abnormal Laboratory Value on Day 29 for Hematology, and Clinical Chemistry
Time frame: At Day 29 compared to baseline (Day 1)
Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participants condition. Normal or missing values refer to laboratory values that were within normal range or missing at baseline.
Geometric Mean Titer (GMT) of Antigen 1 Antibody Titer
Time frame: At Day 29
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Geometric Mean Increase (GMI) of Antigen 1 Antibody Titers From Day 1 to Day 29
Time frame: From Day 1 (baseline) to Day 29
GMI is defined as the geometric mean of the ratios of the post dosing titer over the Day 1 titer. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Percentage of Participants With Antigen 1 Antibody Seroconversion Rate (SCR)
Time frame: From Day 1 to Day 29
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.
Percentage of Participants With Antigen 1 Antibody Seroprotection Rate (SPR)
Time frame: At Day 1
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.
Percentage of Participants With Antigen 1 Antibody SPR
Time frame: At Day 29
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
GMT of Antigen 2 Antibody Titer
Time frame: At Day 29
GMI of Antigen 2 Antibody Titer From Day 1 to Day 29
Time frame: From Day 1 (baseline) to Day 29
Percentage of Participants With Antigen 2 Antibody SCR
Time frame: From Day 1 to Day 29
7 secondary outcomes
GMT of Antigen 1 Antibody Titer
Time frame: At Day 92
GMT of Antigen 1 Antibody Titer
Time frame: At Day 183
GMI of Antigen 1 Antibody Titer From Day 1 to Day 92
Time frame: From Day 1 (baseline) to Day 92
GMI of Antigen 1 Antibody Titer From Day 1 to Day 183
Time frame: From Day 1 (baseline) to Day 183
Percentage of Participants With Antigen 1 Antibody SPR
Time frame: At Day 183
GMT of Antigen 2 Antibody Titer
Time frame: At Day 92 and Day 183
GMI of Antigen 2 Antibody Titer
Time frame: From Day 1 to Day 92 and Day 1 to Day 183
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42875683De Coster I, Cardona JF, Ferguson M, Leroux-Roels I, Nell H, Berre S, Schoonbroodt S, Lorin C, Ovbude LJ, Moldt B; FLU SV mRNA-002 study group. A Phase 1/2 Trial Evaluating the Safety and Immunogenicity of an mRNA-based Seasonal Influenza Vaccine Candidate Encoding Hemagglutinin and Neuraminidase. Infect Dis Ther. 2026 Oct 15. doi: 10.1007/s40121-026-01463-9. Online ahead of print.
- Individual participant dataSharing planned: Yes. 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/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
41 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing F2C22C/DL001Z, F2B22A/DL001Z and F2B22B/DL001Z in people with Influenza, Human, run by GlaxoSmithKline at 41 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, Belgium, Canada, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs) (time frame: Day 1 to Day 7). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05823974, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.