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RECRUITING
NCT07851246
PHASE3

A Study to Evaluate the Immune Response and Safety of a Vaccine Against Influenza in Adults 18-64 Years of Age

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

Summary

This clinical trial will study an investigational seasonal influenza vaccine in adults 18 to 64 years of age. The vaccine is based on messenger ribonucleic acid, also called mRNA. The main goals of the study are to learn how well the vaccine helps the body make an immune response against influenza and what medical problems participants may have after vaccination. Researchers will also compare immune responses in adults 18 to 64 years of age from this study, with immune responses in adults 65 years of age and older from another study. Participants will receive 1 injection into the upper arm muscle and will be followed for about 6 months.

Official title: A Phase 3 Randomized, Observer-Blind, Controlled Study to Evaluate the Immunogenicity, Reactogenicity and Safety of an mRNA-based Seasonal Influenza Vaccine, in Adults 18-64 Years of Age

Key Details

Gender

All

Age Range

18 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

3000

Start Date

2026-10-01

Completion Date

2027-07-09

Last Updated

2026-10-09

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

mRNA Seasonal Flu vaccine

One dose of the mRNA Flu vaccine received intramuscularly.

BIOLOGICAL

Comparator 1

One dose of the comparator vaccine received intramuscularly.

BIOLOGICAL

Comparator 2

One dose of the comparator vaccine received intramuscularly.

Locations (12)

GSK Investigational Site

Glendale, Arizona, United States

GSK Investigational Site

Tucson, Arizona, United States

GSK Investigational Site

San Diego, California, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Miami Lakes, Florida, United States

GSK Investigational Site

Meridian, Idaho, United States

GSK Investigational Site

Valparaiso, Indiana, United States

GSK Investigational Site

Lenexa, Kansas, United States

GSK Investigational Site

Hartsdale, New York, United States

GSK Investigational Site

Spartanburg, South Carolina, United States

GSK Investigational Site

DeSoto, Texas, United States

GSK Investigational Site

Fort Worth, Texas, United States