Influenza, HumanPhase 2NCT06431607
A Study to Find the Dose and Assess the Immune Response and Safety of a Vaccine Against Influenza in Healthy Younger and Older Adults
A Phase 2 study testing F2G22B/DL001Z, F2H23D/DL001Z-NH and F2H23B/DL001Z-NH in people with Influenza, Human, run by GlaxoSmithKline at 18 sites in United States.
Trial summary
The purpose of this study is to assess the safety and immune response of GlaxoSmithKlines (GSK) messenger RNA (mRNA)-based multivalent vaccine (GSK4382276A) candidate against influenza, administered in healthy younger adults (YA) and older adults (OA). 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?
- F2G22B/DL001Z, F2H23D/DL001Z-NH and F2H23B/DL001Z-NH
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 845 participants
- Where
- 18 sitesUnited States
- Study dates
- 23 May 2024to 4 Jun 2025
- Phase
- Phase 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 85 years of age (YAs: 18-64; OAs: 65-85) at the time of the study intervention administration.
- Healthy participants or medically stable patients as established by medical history and clinical examination. Participants with chronic medical conditions with or without specific treatment (e.g., chronic metabolic, cardiac, pulmonary, renal, hepatic, neurologic, and hematologic diseases) are allowed to participate in this study if considered by the investigator as medically stable. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during 3 months before enrolment.
- Body mass index (BMI) >=18 Kilograms per meter square (kg/m²) and less than or equal to (<=) 35kg/m2.
- Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits), independently or with the assistance of a caregiver.
- Written informed consent obtained from the participant prior to performance of any study-specific procedure.
- Female participants of non-childbearing potential may be enrolled in the clinical study.
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- 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.
Who cannot join
- Participant tested positive for influenza by local health authority-approved testing methods within 180 days prior to Day 1.
- Current or past malignancy, unless completely resolved without sequelae for greater than (>) 5 years before the study intervention administration (excluding effectively treated basal cell skin cancer).
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required). HIV-infected individuals may be enrolled if they have been stable on antiretroviral therapy for the past 6 consecutive months, i.e., their treatment has not been modified, their cluster of differentiation 4 (CD4) cell count is >= 200/ cubic millimeter (mm³) and their viral load has been undetectable (i.e., HIV-RNA lesser than (<) 50 copies/milliliter [mL]) (based on medical records, no laboratory testing required).
- Participants with a history of, or current suspicion of myocarditis, pericarditis, or idiopathic cardiomyopathy (including a history of myocarditis or pericarditis following vaccination with an mRNA COVID-19 vaccine), or presence of any medical condition that increases risk of myocarditis or pericarditis, including cocaine abuse, cardiomyopathy, endomyocardial fibrosis, hypereosinophilic syndrome, hypersensitivity myocarditis, eosinophilic granulomatosis with polyangiitis and persistent myocardial infection will be excluded from the study.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention (including polyethylene glycol, egg proteins and aminoglycoside antibiotics).
- Hypersensitivity to latex.
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- Recurrent history 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 condition that in the judgment of the investigator would make intramuscular injection unsafe.
- Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the clinical study.
- Administration of an influenza vaccine within 180 days before enrollment or planned administration prior to Visit 2 (Day 29) after the study intervention administration.
- Previous vaccination with a mRNA influenza vaccine.
- Administration of a vaccine not foreseen by the study protocol in the period starting 30 days (Day -30) before the study intervention administration, or planned administration within 28 days (Visit 2 [Day 29]) after the study intervention administration*.
- If emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is recommended and/or organized by public health authorities outside the routine immunization program, the time period described above can be reduced, provided it is used according to the local governmental recommendations and sponsor is notified.
- Use of any investigational or non-registered product (drug, vaccine or invasive medical device) other than the study intervention during the period beginning 30 days before the study intervention administration, or their planned use during the study period.
- Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the study intervention administration or planned administration during the study period.
- Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune-modifying treatments at any time up to the end of the study.
- Up to 3 months prior to the study intervention administration:
- For corticosteroids, this will mean prednisone equivalent >=20 mg/day. Inhaled, intraarticular and topical steroids are allowed.
- Up to 3 months prior to study intervention administration: long-acting immune-modifying drugs including among others immunotherapy (e.g., TNF-inhibitors), monoclonal antibodies, antitumoral medication.
- Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/invasive medical device).
- Pregnant or lactating female participant.
- Bedridden participants.
- Female participant planning to become pregnant or planning to discontinue contraceptive precautions within the 1-month post-dosing period.
- History of chronic alcohol consumption and/or drug abuse in the past 5 years as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures.
- Any study personnel or their immediate dependents, family, or household members.
- Participants with extensive tattoos covering deltoid region on both arms that would preclude the assessment of local reactogenicity.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
GSK Investigational Site
Austin, Texas, 78705
GSK Investigational Site
Chicago, Illinois, 60640
GSK Investigational Site
El Dorado, Kansas, 67042
GSK Investigational Site
Fort Worth, Texas, 76135
GSK Investigational Site
Greensboro, North Carolina, 27408
GSK Investigational Site
Hialeah, Florida, 33012
GSK Investigational Site
Knoxville, Tennessee, 37909
GSK Investigational Site
Lenexa, Kansas, 66219
GSK Investigational Site
Lexington, Kentucky, 40509
GSK Investigational Site
Miami, Florida, 33147
GSK Investigational Site
Miami, Florida, 33186
GSK Investigational Site
Newport News, Virginia, 23606
GSK Investigational Site
Newton, Kansas, 67114
GSK Investigational Site
Norfolk, Virginia, 23502
GSK Investigational Site
Rochester, New York, 14609
GSK Investigational Site
Tomball, Texas, 77375
GSK Investigational Site
Valparaiso, Indiana, 46383
GSK Investigational Site
Wichita, Kansas, 67207
About this study
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
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).
- Conditions
- Influenza, Human
- Being tested
- F2G22B/DL001Z, F2H23D/DL001Z-NH, F2H23B/DL001Z-NH, F2H23H/DL001Z, FDQ23A-NH (Flu D-QIV)
- 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.
F2G22B/DL001ZBiological
Study intervention was administered intramuscularly at Day 1.
F2H23D/DL001Z-NHBiological
Study intervention was administered intramuscularly at Day 1.
F2H23B/DL001Z-NHBiological
Study intervention was administered intramuscularly at Day 1.
F2H23H/DL001ZBiological
Study intervention was administered intramuscularly at Day 1.
FDQ23A-NH (Flu D-QIV)Combination product
Control Vaccine was administered intramuscularly at Day 1.
GSK5800544ABiological
Study intervention was administered intramuscularly at Day 1.
Flu D-TIVCombination product
Control Vaccine was administered intramuscularly at Day 1.
F2H23A/DL001Z-NHBiological
Study intervention was administered intramuscularly at Day 1.
F2H23G/DL001ZBiological
Study intervention was administered intramuscularly at Day 1.
Fluzone HD QuadrivalentCombination product
Control vaccine was administered intramuscularly at Day 1.
Fluzone HDCombination product
Control vaccine was administered intramuscularly at Day 1.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 YA: Flu mRNA_1_Younger Adults (YA) | Experimental | YA participants received a single dose of Flu mRNA study intervention F2G22B/DL001Z administered at Day 1. Receives: Biological: F2G22B/DL001Z |
| Part 1 YA: Flu mRNA_2_YA | Experimental | YA participants received a single dose of Flu mRNA study intervention F2H23D/DL001Z-NH administered at Day 1. Receives: Biological: F2H23D/DL001Z-NH |
| Part 1 YA: Flu mRNA_3_YA | Experimental | YA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1. Receives: Biological: F2H23B/DL001Z-NH |
| Part 1 YA: Flu mRNA_4_YA | Experimental | YA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1. Receives: Biological: F2H23H/DL001Z |
| Part 1 YA: Comparator_1_YA | Active comparator | YA participants received a single dose of Comparator 1 [FDQ23A-NH (Flu D-QIV)] administered at Day 1. Receives: Combination Product: FDQ23A-NH (Flu D-QIV) |
| Part 2 YA: Flu mRNA_9_YA | Experimental | YA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1. Receives: Biological: GSK5800544A |
| Part 2 YA: Comparator_2_YA | Active comparator | YA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1. Receives: Combination Product: Flu D-TIV |
| Part 1 OA: Flu mRNA_5_Older Adults (OA) | Experimental | OA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1. Receives: Biological: F2H23B/DL001Z-NH |
| Part 1 OA: Flu mRNA_6_OA | Experimental | OA participants received a single dose of Flu mRNA study intervention F2H23A/DL001Z-NH administered at Day 1. Receives: Biological: F2H23A/DL001Z-NH |
| Part 1 OA: Flu mRNA_7_OA | Experimental | OA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1. Receives: Biological: F2H23H/DL001Z |
| Part 1 OA: Flu mRNA_8_OA | Experimental | OA participants received a single dose of Flu mRNA study intervention F2H23G/DL001Z administered at Day 1. Receives: Biological: F2H23G/DL001Z |
| Part 1 OA: Comparator_1_OA | Active comparator | OA participants received a single dose of Comparator 1 (Fluzone HD Quadrivalent) administered at Day 1. Receives: Combination Product: Fluzone HD Quadrivalent |
| Part 2 OA: Flu mRNA_10_OA | Experimental | OA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1. Receives: Biological: GSK5800544A |
| Part 2 OA: Comparator_2_OA | Active comparator | OA participants received a single dose of Comparator 2 (Fluzone HD) administered at Day 1. Receives: Combination Product: Fluzone HD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 YA: Geometric Mean Titer (GMT) of Antigen 1 Antibody Titer
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Measured: At Day 29
Part 2 YA: GMT of Antigen 1 Antibody Titer
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Measured: At Day 29
Part 1 OA: GMT of Antigen 1 Antibody Titer
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Measured: At Day 29
Part 2 OA: GMT of Antigen 1 Antibody Titer
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Measured: At Day 29
Part 1 YA: Geometric Mean Increase (GMI) of Antigen 1 Antibody Titers
GMI is defined as the geometric mean of the ratios of the post dosing titer over the Day 1 titer. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Measured: From Day 1 (baseline) to Day 29
Part 2 YA: GMI of Antigen 1 Antibody Titers
GMI is defined as the geometric mean of the ratios of the post dosing titer over the Day 1 titer. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Measured: From Day 1 (baseline) to Day 29
Part 1 OA: GMI of Antigen 1 Antibody Titers
GMI is defined as the geometric mean of the ratios of the post dosing titer over the Day 1 titer. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Measured: From Day 1 (baseline) to Day 29
Part 2 OA: GMI of Antigen 1 Antibody Titers
GMI is defined as the geometric mean of the ratios of the post dosing titer over the Day 1 titer. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Measured: From Day 1 (baseline) to Day 29
Part 1 YA: Percentage of Participants With Antigen 1 Antibody Seroconversion Rate (SCR)
SCR is defined as the percentage of dosed participants who have either an anti-vaccine antibody pre-dose titer < 1:10 and a post-dose anti-vaccine antibody titer >= 1:40 or a pre-dose anti-vaccine antibody titer >= 1:10 and at least a 4-fold increase in post-dose anti-vaccine antibody titer. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Measured: From Day 1 (baseline) to Day 29
Part 2 YA: Percentage of Participants With Antigen 1 Antibody SCR
SCR is defined as the percentage of dosed participants who have either an anti-vaccine antibody pre-dose titer < 1:10 and a post-dose anti-vaccine antibody titer >= 1:40 or a pre-dose anti-vaccine antibody titer >= 1:10 and at least a 4-fold increase in post-dose anti-vaccine antibody titer. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Measured: From Day 1 (baseline) to Day 29
Part 1 OA: Percentage of Participants With Antigen 1 Antibody SCR
SCR is defined as the percentage of dosed participants who have either an anti-vaccine antibody pre-dose titer < 1:10 and a post-dose anti-vaccine antibody titer >= 1:40 or a pre-dose anti-vaccine antibody titer >= 1:10 and at least a 4-fold increase in post-dose anti-vaccine antibody titer. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Measured: From Day 1 (baseline) to Day 29
Part 2 OA: Percentage of Participants With Antigen 1 Antibody SCR
SCR is defined as the percentage of dosed participants who have either an anti-vaccine antibody pre-dose titer < 1:10 and a post-dose anti-vaccine antibody titer >= 1:40 or a pre-dose anti-vaccine antibody titer >= 1:10 and at least a 4-fold increase in post-dose anti-vaccine antibody titer. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Measured: From Day 1 (baseline) to Day 29
Part 1 YA: Percentage of Participants With Antigen 1 Antibody Seroprotection Rate (SPR)
SPR is defined as the percentage of dosed participants with a anti-vaccine antibody titer >= 1:40. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Measured: At Day 1
Part 2 YA: Percentage of Participants With Antigen 1 Antibody SPR
SPR is defined as the percentage of dosed participants with a anti-vaccine antibody titer >= 1:40. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Measured: At Day 1
Part 1 OA: Percentage of Participants With Antigen 1 Antibody SPR
SPR is defined as the percentage of dosed participants with a anti-vaccine antibody titer >= 1:40. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Measured: At Day 1
Part 2 OA: Percentage of Participants With Antigen 1 Antibody SPR
SPR is defined as the percentage of dosed participants with a anti-vaccine antibody titer >= 1:40. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Measured: At Day 1
Part 1 YA: Percentage of Participants With Antigen 1 Antibody SPR
SPR is defined as the percentage of dosed participants with a anti-vaccine antibody titer >= 1:40. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Measured: At Day 29
Part 2 YA: Percentage of Participants With Antigen 1 Antibody SPR
SPR is defined as the percentage of dosed participants with a anti-vaccine antibody titer >= 1:40. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Measured: At Day 29
Part 1 OA: Percentage of Participants With Antigen 1 Antibody SPR
SPR is defined as the percentage of dosed participants with a anti-vaccine antibody titer >= 1:40. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Measured: At Day 29
Part 2 OA: Percentage of Participants With Antigen 1 Antibody SPR
SPR is defined as the percentage of dosed participants with a anti-vaccine antibody titer >= 1:40. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Measured: At Day 29
Secondary outcomes (36)
Part 1 YA: GMT of Antigen 2 Antibody Titer
Measured: At Day 29
Part 2 YA: GMT of Antigen 2 Antibody Titer
Measured: At Day 29
Part 1 OA: GMT of Antigen 2 Antibody Titer
Measured: At Day 29
Part 2 OA: GMT of Antigen 2 Antibody Titer
Measured: At Day 29
Part 1 YA: GMI of Antigen 2 Antibody Titer
Measured: From Day 1 (baseline) to Day 29
Part 2 YA: GMI of Antigen 2 Antibody Titer
Measured: From Day 1 (baseline) to Day 29
Part 1 OA: GMI of Antigen 2 Antibody Titer
Measured: From Day 1 (baseline) to Day 29
Part 2 OA: GMI of Antigen 2 Antibody Titer
Measured: From Day 1 (baseline) to Day 29
Part 1 YA: Percentage of Participants With Antigen 2 Antibody SCR
Measured: From Day 1 (baseline) to Day 29
Part 2 YA: Percentage of Participants With Antigen 2 Antibody SCR
Measured: From Day 1 (baseline) to Day 29
Part 1 OA: Percentage of Participants With Antigen 2 Antibody SCR
Measured: From Day 1 (baseline) to Day 29
Part 2 OA: Percentage of Participants With Antigen 2 Antibody SCR
Measured: From Day 1 (baseline) to Day 29
Part 1 YA: Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs)
Assessed solicited administration site events included pain, redness (erythema), swelling, lymphadenopathy (defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm). Any = occurrence of the event regardless of intensity grade.
Measured: Day 1 to Day 7
Part 2 YA: Number of Participants Reporting Any Solicited Administration Site AEs
Assessed solicited administration site events included pain, redness (Erythema), swelling, lymphadenopathy (defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm). Any = occurrence of the event regardless of intensity grade.
Measured: Day 1 to Day 7
Part 1 OA: Number of Participants Reporting Any Solicited Administration Site AEs
Assessed solicited administration site events included pain, redness (Erythema), swelling, lymphadenopathy (defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm). Any = occurrence of the event regardless of intensity grade.
Measured: Day 1 to Day 7
Part 2 OA: Number of Participants Reporting Any Solicited Administration Site AEs
Assessed solicited administration site events included pain, redness (Erythema), swelling, lymphadenopathy (defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm). Any = occurrence of the event regardless of intensity grade.
Measured: Day 1 to Day 7
Part 1 YA: Number of Participants Reporting Any Solicited Systemic AEs
Assessed solicited systemic events included fever (pyrexia) which is defined as axillary temperature greater than or equal to (>=) 38.0°C/100.4°F, chills, headache, fatigue (tiredness), myalgia (muscle joint), and arthralgia (joint pain). Any = occurrence of the event regardless of intensity grade.
Measured: Day 1 to Day 7
Part 2 YA: Number of Participants Reporting Any Solicited Systemic AEs
Assessed solicited systemic events included fever (pyrexia) which is defined as axillary temperature >= 38.0°C/100.4°F, chills, headache, fatigue (tiredness), myalgia (muscle joint), and arthralgia (joint pain). Any = occurrence of the event regardless of intensity grade.
Measured: Day 1 to Day 7
Part 1 OA: Number of Participants Reporting Any Solicited Systemic AEs
Assessed solicited systemic events included fever (pyrexia) which is defined as axillary temperature >= 38.0°C/100.4°F, chills, headache, fatigue (tiredness), myalgia (muscle joint), and arthralgia (joint pain). Any = occurrence of the event regardless of intensity grade.
Measured: Day 1 to Day 7
Part 2 OA: Number of Participants Reporting Any Solicited Systemic AEs
Assessed solicited systemic events included fever (pyrexia) which is defined as axillary temperature >= 38.0°C/100.4°F, chills, headache, fatigue (tiredness), myalgia (muscle joint), and arthralgia (joint pain). Any = occurrence of the event regardless of intensity grade.
Measured: Day 1 to Day 7
Part 1 YA: Number of Participants Reporting Any Unsolicited AEs
An unsolicited AE is defined as an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow up for solicited events. Unsolicited AEs include both serious and non-serious AEs. Any = occurrence the event regardless of intensity grade.
Measured: Day 1 to Day 28
Part 2 YA: Number of Participants Reporting Any Unsolicited AEs
An unsolicited AE is defined as an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow up for solicited events. Unsolicited AEs include both serious and non-serious AEs. Any = occurrence the event regardless of intensity grade.
Measured: Day 1 to Day 28
Part 1 OA: Number of Participants Reporting Any Unsolicited AEs
An unsolicited AE is defined as an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow up for solicited events. Unsolicited AEs include both serious and non-serious AEs. Any = occurrence the event regardless of intensity grade.
Measured: Day 1 to Day 28
Part 2 OA: Number of Participants Reporting Any Unsolicited AEs
An unsolicited AE is defined as an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow up for solicited events. Unsolicited AEs include both serious and non-serious AEs. Any = occurrence the event regardless of intensity grade.
Measured: Day 1 to Day 28
Part 1 YA: Number of Participants Reporting Serious Adverse Events (SAEs)
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, is an abnormal pregnancy outcome, or is a suspected transmission of any infectious agent via an authorized medicinal product. Any = occurrence the event regardless of intensity grade.
Measured: Day 1 to Day 183
Part 2 YA: Number of Participants Reporting SAEs
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, is an abnormal pregnancy outcome, or is a suspected transmission of any infectious agent via an authorized medicinal product. Any = occurrence the event regardless of intensity grade.
Measured: Day 1 to Day 183
Part 1 OA: Number of Participants Reporting SAEs
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, is an abnormal pregnancy outcome, or is a suspected transmission of any infectious agent via an authorized medicinal product. Any = occurrence the event regardless of intensity grade.
Measured: Day 1 to Day 183
Part 2 OA: Number of Participants Reporting SAEs
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, is an abnormal pregnancy outcome, or is a suspected transmission of any infectious agent via an authorized medicinal product. Any = occurrence the event regardless of intensity grade.
Measured: Day 1 to Day 183
Part 1 YA: Number of Participants Reporting AEs of Special Interest (AESIs)
The following events were considered as AESI in this study: severe hypersensitivity reactions within 24 hours after study intervention administration, myocarditis/pericarditis and potential immune-mediated diseases (pIMDs). Any = occurrence the event regardless of intensity grade.
Measured: Day 1 to Day 183
Part 2 YA: Number of Participants Reporting AESIs
The following events were considered as AESI in this study: severe hypersensitivity reactions within 24 hours after study intervention administration, myocarditis/pericarditis and potential immune-mediated diseases (pIMDs). Any = occurrence the event regardless of intensity grade.
Measured: Day 1 to Day 183
Part 1 OA: Number of Participants Reporting AESIs
The following events were considered as AESI in this study: severe hypersensitivity reactions within 24 hours after study intervention administration, myocarditis/pericarditis and potential immune-mediated diseases (pIMDs). Any = occurrence the event regardless of intensity grade.
Measured: Day 1 to Day 183
Part 2 OA: Number of Participants Reporting AESIs
The following events were considered as AESI in this study: severe hypersensitivity reactions within 24 hours after study intervention administration, myocarditis/pericarditis and potential immune-mediated diseases (pIMDs). Any = occurrence the event regardless of intensity grade.
Measured: Day 1 to Day 183
Part 1 YA: Number of Participants Reporting Medically Attended Adverse Events (MAAEs)
MAE is defined as an AE that results in an unscheduled visit to a medical professional (e.g., physician's office visits, emergency room visits or hospitalization). Any = occurrence the event regardless of intensity grade.
Measured: Day 1 to Day 183
Part 2 YA: Number of Participants Reporting MAAEs
MAE is defined as an AE that results in an unscheduled visit to a medical professional (e.g., physician's office visits, emergency room visits or hospitalization). Any = occurrence the event regardless of intensity grade.
Measured: Day 1 to Day 183
Part 1 OA: Number of Participants Reporting MAAEs
MAE is defined as an AE that results in an unscheduled visit to a medical professional (e.g., physician's office visits, emergency room visits or hospitalization). Any = occurrence the event regardless of intensity grade.
Measured: Day 1 to Day 183
Part 2 OA: Number of Participants Reporting MAAEs
MAE is defined as an AE that results in an unscheduled visit to a medical professional (e.g., physician's office visits, emergency room visits or hospitalization). Any = occurrence the event regardless of intensity grade.
Measured: 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 posted28 May 2024
- Study start23 May 2024
- Primary completion27 Dec 2024
- Study completion4 Jun 2025
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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 845 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06431607
- Sponsor's protocol ID
- 222853
- Status last verified
- Feb 2026
- First submitted
- 22 May 2024
- Last updated
- 10 Mar 2026
- 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
Moldt B, Ubeda RA, Murray AV, Tima G, Germain S, Lorin C, Ovbude LJ, Steinbrecher D, Nordgren M; FLU SV mRNA-024 study group. A Phase 2 Trial Evaluating the Immunogenicity and Safety of an mRNA-Based Seasonal Influenza Vaccine Candidate Encoding Hemagglutinin and Neuraminidase. Infect Dis Ther. 2026 Oct 15. doi: 10.1007/s40121-026-01462-w. Online ahead of print.
PubMed 42875682
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06431607
- Acronym / sponsor ID
- 222853
- Conditions
- Influenza, Human
- Keywords
- Influenza, Safety, Reactogenicity, Immunogenicity, mRNA vaccine, Healthy younger adults, Healthy older adults
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 845 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 23 May 2024 (actual)
- Primary completion
- 27 Dec 2024 (actual)
- Study completion
- 4 Jun 2025 (actual)
- First posted
- 28 May 2024 (actual)
- Results
- Posted 10 Mar 2026
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 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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| Part 1 YA: Flu mRNA_1_Younger Adults (YA) | Experimental | Biological: F2G22B/DL001ZYA participants received a single dose of Flu mRNA study intervention F2G22B/DL001Z administered at Day 1. |
| Part 1 YA: Flu mRNA_2_YA | Experimental | Biological: F2H23D/DL001Z-NHYA participants received a single dose of Flu mRNA study intervention F2H23D/DL001Z-NH administered at Day 1. |
| Part 1 YA: Flu mRNA_3_YA | Experimental | Biological: F2H23B/DL001Z-NHYA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1. |
| Part 1 YA: Flu mRNA_4_YA | Experimental | Biological: F2H23H/DL001ZYA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1. |
| Part 1 YA: Comparator_1_YA | Active comparator | Combination Product: FDQ23A-NH (Flu D-QIV)YA participants received a single dose of Comparator 1 [FDQ23A-NH (Flu D-QIV)] administered at Day 1. |
| Part 2 YA: Flu mRNA_9_YA | Experimental | Biological: GSK5800544AYA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1. |
| Part 2 YA: Comparator_2_YA | Active comparator | Combination Product: Flu D-TIVYA participants received a single dose of Comparator 2 (Flu D-TIV) administered at Day 1. |
| Part 1 OA: Flu mRNA_5_Older Adults (OA) | Experimental | Biological: F2H23B/DL001Z-NHOA participants received a single dose of Flu mRNA study intervention F2H23B/DL001Z-NH administered at Day 1. |
| Part 1 OA: Flu mRNA_6_OA | Experimental | Biological: F2H23A/DL001Z-NHOA participants received a single dose of Flu mRNA study intervention F2H23A/DL001Z-NH administered at Day 1. |
| Part 1 OA: Flu mRNA_7_OA | Experimental | Biological: F2H23H/DL001ZOA participants received a single dose of Flu mRNA study intervention F2H23H/DL001Z administered at Day 1. |
| Part 1 OA: Flu mRNA_8_OA | Experimental | Biological: F2H23G/DL001ZOA participants received a single dose of Flu mRNA study intervention F2H23G/DL001Z administered at Day 1. |
| Part 1 OA: Comparator_1_OA | Active comparator | Combination Product: Fluzone HD QuadrivalentOA participants received a single dose of Comparator 1 (Fluzone HD Quadrivalent) administered at Day 1. |
| Part 2 OA: Flu mRNA_10_OA | Experimental | Biological: GSK5800544AOA participants received a single dose of Flu mRNA study intervention GSK5800544A administered at Day 1. |
| Part 2 OA: Comparator_2_OA | Active comparator | Combination Product: Fluzone HDOA participants received a single dose of Comparator 2 (Fluzone HD) administered 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 85 years of age (YAs: 18-64; OAs: 65-85) at the time of the study intervention administration.
- Healthy participants or medically stable patients as established by medical history and clinical examination. Participants with chronic medical conditions with or without specific treatment (e.g., chronic metabolic, cardiac, pulmonary, renal, hepatic, neurologic, and hematologic diseases) are allowed to participate in this study if considered by the investigator as medically stable. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during 3 months before enrolment.
- Body mass index (BMI) >=18 Kilograms per meter square (kg/m²) and less than or equal to (<=) 35kg/m2.
- Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits), independently or with the assistance of a caregiver.
- Written informed consent obtained from the participant prior to performance of any study-specific procedure.
Key exclusion criteria (27 listed)
- Participant tested positive for influenza by local health authority-approved testing methods within 180 days prior to Day 1.
- Current or past malignancy, unless completely resolved without sequelae for greater than (>) 5 years before the study intervention administration (excluding effectively treated basal cell skin cancer).
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required). HIV-infected individuals may be enrolled if they have been stable on antiretroviral therapy for the past 6 consecutive months, i.e., their treatment has not been modified, their cluster of differentiation 4 (CD4) cell count is >= 200/ cubic millimeter (mm³) and their viral load has been undetectable (i.e., HIV-RNA lesser than (<) 50 copies/milliliter [mL]) (based on medical records, no laboratory testing required).
- Participants with a history of, or current suspicion of myocarditis, pericarditis, or idiopathic cardiomyopathy (including a history of myocarditis or pericarditis following vaccination with an mRNA COVID-19 vaccine), or presence of any medical condition that increases risk of myocarditis or pericarditis, including cocaine abuse, cardiomyopathy, endomyocardial fibrosis, hypereosinophilic syndrome, hypersensitivity myocarditis, eosinophilic granulomatosis with polyangiitis and persistent myocardial infection will be excluded from the study.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention (including polyethylene glycol, egg proteins and aminoglycoside antibiotics).
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 |
|---|---|---|
| F2G22B/DL001ZStudy intervention was administered intramuscularly at Day 1. | Biological | Part 1 YA: Flu mRNA_1_Younger Adults (YA) |
| F2H23D/DL001Z-NHStudy intervention was administered intramuscularly at Day 1. | Biological | Part 1 YA: Flu mRNA_2_YA |
| F2H23B/DL001Z-NHStudy intervention was administered intramuscularly at Day 1. | Biological | Part 1 OA: Flu mRNA_5_Older Adults (OA), Part 1 YA: Flu mRNA_3_YA |
| F2H23H/DL001ZStudy intervention was administered intramuscularly at Day 1. | Biological | Part 1 OA: Flu mRNA_7_OA, Part 1 YA: Flu mRNA_4_YA |
| FDQ23A-NH (Flu D-QIV)Control Vaccine was administered intramuscularly at Day 1. | Combination product | Part 1 YA: Comparator_1_YA |
| GSK5800544AStudy intervention was administered intramuscularly at Day 1. | Biological | Part 2 OA: Flu mRNA_10_OA, Part 2 YA: Flu mRNA_9_YA |
| Flu D-TIVControl Vaccine was administered intramuscularly at Day 1. | Combination product | Part 2 YA: Comparator_2_YA |
| F2H23A/DL001Z-NHStudy intervention was administered intramuscularly at Day 1. | Biological | Part 1 OA: Flu mRNA_6_OA |
| F2H23G/DL001ZStudy intervention was administered intramuscularly at Day 1. | Biological | Part 1 OA: Flu mRNA_8_OA |
| Fluzone HD QuadrivalentControl vaccine was administered intramuscularly at Day 1. | Combination product | Part 1 OA: Comparator_1_OA |
| Fluzone HDControl vaccine was administered intramuscularly at Day 1. | Combination product | Part 2 OA: Comparator_2_OA |
Primary outcome
Part 1 YA: 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.
Part 2 YA: 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.
Part 1 OA: 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.
Part 2 OA: 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.
Part 1 YA: Geometric Mean Increase (GMI) of Antigen 1 Antibody Titers
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.
Part 2 YA: GMI of Antigen 1 Antibody Titers
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.
Part 1 OA: GMI of Antigen 1 Antibody Titers
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.
Part 2 OA: GMI of Antigen 1 Antibody Titers
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.
Part 1 YA: Percentage of Participants With Antigen 1 Antibody Seroconversion Rate (SCR)
Time frame: From Day 1 (baseline) 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.
Part 2 YA: Percentage of Participants With Antigen 1 Antibody SCR
Time frame: From Day 1 (baseline) 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.
Part 1 OA: Percentage of Participants With Antigen 1 Antibody SCR
Time frame: From Day 1 (baseline) 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.
Part 2 OA: Percentage of Participants With Antigen 1 Antibody SCR
Time frame: From Day 1 (baseline) 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.
Part 1 YA: 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.
Part 2 YA: Percentage of Participants With Antigen 1 Antibody 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.
Part 1 OA: Percentage of Participants With Antigen 1 Antibody 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.
Part 2 OA: Percentage of Participants With Antigen 1 Antibody 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.
Part 1 YA: Percentage of Participants With Antigen 1 Antibody SPR
Time frame: At Day 29
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.
Part 2 YA: Percentage of Participants With Antigen 1 Antibody SPR
Time frame: At Day 29
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.
Part 1 OA: Percentage of Participants With Antigen 1 Antibody SPR
Time frame: At Day 29
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.
Part 2 OA: Percentage of Participants With Antigen 1 Antibody SPR
Time frame: At Day 29
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.
36 secondary outcomes
Part 1 YA: GMT of Antigen 2 Antibody Titer
Time frame: At Day 29
Part 2 YA: GMT of Antigen 2 Antibody Titer
Time frame: At Day 29
Part 1 OA: GMT of Antigen 2 Antibody Titer
Time frame: At Day 29
Part 2 OA: GMT of Antigen 2 Antibody Titer
Time frame: At Day 29
Part 1 YA: GMI of Antigen 2 Antibody Titer
Time frame: From Day 1 (baseline) to Day 29
Part 2 YA: GMI of Antigen 2 Antibody Titer
Time frame: From Day 1 (baseline) to Day 29
Part 1 OA: GMI of Antigen 2 Antibody Titer
Time frame: From Day 1 (baseline) to Day 29
Part 2 OA: GMI of Antigen 2 Antibody Titer
Time frame: From Day 1 (baseline) to Day 29
Part 1 YA: Percentage of Participants With Antigen 2 Antibody SCR
Time frame: From Day 1 (baseline) to Day 29
Part 2 YA: Percentage of Participants With Antigen 2 Antibody SCR
Time frame: From Day 1 (baseline) to Day 29
Part 1 OA: Percentage of Participants With Antigen 2 Antibody SCR
Time frame: From Day 1 (baseline) to Day 29
Part 2 OA: Percentage of Participants With Antigen 2 Antibody SCR
Time frame: From Day 1 (baseline) to Day 29
Part 1 YA: Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs)
Time frame: Day 1 to Day 7
Part 2 YA: Number of Participants Reporting Any Solicited Administration Site AEs
Time frame: Day 1 to Day 7
Part 1 OA: Number of Participants Reporting Any Solicited Administration Site AEs
Time frame: Day 1 to Day 7
Part 2 OA: Number of Participants Reporting Any Solicited Administration Site AEs
Time frame: Day 1 to Day 7
Part 1 YA: Number of Participants Reporting Any Solicited Systemic AEs
Time frame: Day 1 to Day 7
Part 2 YA: Number of Participants Reporting Any Solicited Systemic AEs
Time frame: Day 1 to Day 7
Part 1 OA: Number of Participants Reporting Any Solicited Systemic AEs
Time frame: Day 1 to Day 7
Part 2 OA: Number of Participants Reporting Any Solicited Systemic AEs
Time frame: Day 1 to Day 7
Part 1 YA: Number of Participants Reporting Any Unsolicited AEs
Time frame: Day 1 to Day 28
Part 2 YA: Number of Participants Reporting Any Unsolicited AEs
Time frame: Day 1 to Day 28
Part 1 OA: Number of Participants Reporting Any Unsolicited AEs
Time frame: Day 1 to Day 28
Part 2 OA: Number of Participants Reporting Any Unsolicited AEs
Time frame: Day 1 to Day 28
Part 1 YA: Number of Participants Reporting Serious Adverse Events (SAEs)
Time frame: Day 1 to Day 183
Part 2 YA: Number of Participants Reporting SAEs
Time frame: Day 1 to Day 183
Part 1 OA: Number of Participants Reporting SAEs
Time frame: Day 1 to Day 183
Part 2 OA: Number of Participants Reporting SAEs
Time frame: Day 1 to Day 183
Part 1 YA: Number of Participants Reporting AEs of Special Interest (AESIs)
Time frame: Day 1 to Day 183
Part 2 YA: Number of Participants Reporting AESIs
Time frame: Day 1 to Day 183
Part 1 OA: Number of Participants Reporting AESIs
Time frame: Day 1 to Day 183
Part 2 OA: Number of Participants Reporting AESIs
Time frame: Day 1 to Day 183
Part 1 YA: Number of Participants Reporting Medically Attended Adverse Events (MAAEs)
Time frame: Day 1 to Day 183
Part 2 YA: Number of Participants Reporting MAAEs
Time frame: Day 1 to Day 183
Part 1 OA: Number of Participants Reporting MAAEs
Time frame: Day 1 to Day 183
Part 2 OA: Number of Participants Reporting MAAEs
Time frame: 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 10 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42875682Moldt B, Ubeda RA, Murray AV, Tima G, Germain S, Lorin C, Ovbude LJ, Steinbrecher D, Nordgren M; FLU SV mRNA-024 study group. A Phase 2 Trial Evaluating the Immunogenicity and Safety of an mRNA-Based Seasonal Influenza Vaccine Candidate Encoding Hemagglutinin and Neuraminidase. Infect Dis Ther. 2026 Oct 15. doi: 10.1007/s40121-026-01462-w. 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.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing F2G22B/DL001Z, F2H23D/DL001Z-NH and F2H23B/DL001Z-NH in people with Influenza, Human, run by GlaxoSmithKline at 18 sites in United States.
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 27 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 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. 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 phase mean?
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 10 Mar 2026). 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?
Part 1 YA: Geometric Mean Titer (GMT) of Antigen 1 Antibody Titer (time frame: At Day 29). The study lists 20 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 NCT06431607, 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 10 Mar 2026.