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

NCT06431607 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 222853
• Study Type: interventional
• Target: 845
• Locations: 1 country
• Sites: 18

Brief 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).

Conditions

Influenza, Human

Keywords

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

Outcome Measures

Primary Outcomes (20)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  At Day 29

Secondary Outcomes (36)

• Part 1 YA: GMT of Antigen 2 Antibody Titer

  At Day 29

• Part 2 YA: GMT of Antigen 2 Antibody Titer

  At Day 29

• Part 1 OA: GMT of Antigen 2 Antibody Titer

  At Day 29

• Part 2 OA: GMT of Antigen 2 Antibody Titer

  At Day 29

• Part 1 YA: GMI of Antigen 2 Antibody Titer

  From Day 1 (baseline) to Day 29

Study Arms (14)

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Combination Product: Fluzone HD

Interventions

F2G22B/DL001Z BIOLOGICAL

Study intervention was administered intramuscularly at Day 1.

Part 1 YA: Flu mRNA_1_Younger Adults (YA)

F2H23D/DL001Z-NH BIOLOGICAL

Study intervention was administered intramuscularly at Day 1.

Part 1 YA: Flu mRNA_2_YA

F2H23B/DL001Z-NH BIOLOGICAL

Study intervention was administered intramuscularly at Day 1.

Part 1 OA: Flu mRNA_5_Older Adults (OA); Part 1 YA: Flu mRNA_3_YA

F2H23H/DL001Z BIOLOGICAL

Study intervention was administered intramuscularly at Day 1.

Part 1 OA: Flu mRNA_7_OA; Part 1 YA: Flu mRNA_4_YA

FDQ23A-NH (Flu D-QIV) COMBINATION_PRODUCT

Control Vaccine was administered intramuscularly at Day 1.

Part 1 YA: Comparator_1_YA

GSK5800544A BIOLOGICAL

Study intervention was administered intramuscularly at Day 1.

Part 2 OA: Flu mRNA_10_OA; Part 2 YA: Flu mRNA_9_YA

Flu D-TIV COMBINATION_PRODUCT

Control Vaccine was administered intramuscularly at Day 1.

Part 2 YA: Comparator_2_YA

F2H23A/DL001Z-NH BIOLOGICAL

Study intervention was administered intramuscularly at Day 1.

Part 1 OA: Flu mRNA_6_OA

F2H23G/DL001Z BIOLOGICAL

Study intervention was administered intramuscularly at Day 1.

Part 1 OA: Flu mRNA_8_OA

Fluzone HD Quadrivalent COMBINATION_PRODUCT

Control vaccine was administered intramuscularly at Day 1.

Part 1 OA: Comparator_1_OA

Fluzone HD COMBINATION_PRODUCT

Control vaccine was administered intramuscularly at Day 1.

Part 2 OA: Comparator_2_OA

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (18)

GSK Investigational Site

Hialeah, Florida, 33012, United States

Location

GSK Investigational Site

Miami, Florida, 33147, United States

Location

GSK Investigational Site

Miami, Florida, 33186, United States

Location

GSK Investigational Site

Chicago, Illinois, 60640, United States

Location

GSK Investigational Site

Valparaiso, Indiana, 46383, United States

Location

GSK Investigational Site

El Dorado, Kansas, 67042, United States

Location

GSK Investigational Site

Lenexa, Kansas, 66219, United States

Location

GSK Investigational Site

Newton, Kansas, 67114, United States

Location

GSK Investigational Site

Wichita, Kansas, 67207, United States

Location

GSK Investigational Site

Lexington, Kentucky, 40509, United States

Location

GSK Investigational Site

Rochester, New York, 14609, United States

Location

GSK Investigational Site

Greensboro, North Carolina, 27408, United States

Location

GSK Investigational Site

Knoxville, Tennessee, 37909, United States

Location

GSK Investigational Site

Austin, Texas, 78705, United States

Location

GSK Investigational Site

Fort Worth, Texas, 76135, United States

Location

GSK Investigational Site

Tomball, Texas, 77375, United States

Location

GSK Investigational Site

Newport News, Virginia, 23606, United States

Location

GSK Investigational Site

Norfolk, Virginia, 23502, United States

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is an observer blind study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: May 28, 2024
• Study Start: May 23, 2024
• Primary Completion: December 27, 2024
• Study Completion: June 4, 2025
• Last Updated: March 10, 2026
• Results First Posted: March 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

US (18)