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A Study to Assess the Safety and Immune Response of a Vaccine Against Influenza in Healthy Younger and Older Adults | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

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

NCT05823974•GlaxoSmithKline

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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.
•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

Exclusion Criteria

•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).
•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.
+18 more criteria

Locations (41)

GSK Investigational Site

Hialeah, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Chicago, Illinois, United States

GSK Investigational Site

Valparaiso, Indiana, United States

GSK Investigational Site

Lenexa, Kansas, United States

GSK Investigational Site

Wichita, Kansas, United States

GSK Investigational Site

Lexington, Kentucky, United States

GSK Investigational Site

Boston, Massachusetts, United States

GSK Investigational Site

Dearborn, Michigan, United States

GSK Investigational Site

Papillion, Nebraska, United States

Key Dates

Start Date

April 27, 2023

Primary Completion Date

July 2, 2024

Completion Date

December 18, 2024

Last Updated

July 23, 2025

Enrollment

1,275

ACTUAL participants

Conditions

Influenza, Human

Interventions

F2C22C/DL001Z

BIOLOGICAL

F2B22A/DL001Z

BIOLOGICAL

F2B22B/DL001Z

BIOLOGICAL

F2B22C/DL001Z

BIOLOGICAL

F2B22D/DL001Z

BIOLOGICAL

F2B22E/DL001Z

BIOLOGICAL

F2F22A/DL001Z

BIOLOGICAL

F2F22B/DL001Z

BIOLOGICAL

F2F22C/DL001Z

BIOLOGICAL

F2F22D/DL001Z

BIOLOGICAL

F2F22E/DL001Z

BIOLOGICAL

Control 1

COMBINATION_PRODUCT

F2F23D/DL001Z-NH

BIOLOGICAL

F2F23A/DL001Z-NH

BIOLOGICAL

F2F23B/DL001Z-NH

BIOLOGICAL

Control 2

COMBINATION_PRODUCT

F2F23C/DL001Z-NH

BIOLOGICAL

Control 3

COMBINATION_PRODUCT

F2F22F/DL001Z

BIOLOGICAL

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covid19 InfectionInfluenza, Human

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Influenza, HumanInfluenza a+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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A Study on the Safety, Reactogenicity and Immune Response of a Vaccine Against Influenza in Healthy Younger and Older Adults

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