NCT05823974

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 1,275 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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).

Conditions

• Influenza, Human

Interventions

Type	Name	Description
BIOLOGICAL	F2C22C/DL001Z	Study intervention was administered intramuscularly in Phase 1, at Day 1.
BIOLOGICAL	F2B22A/DL001Z	Study intervention was administered intramuscularly in Phase 1, at Day 1.
BIOLOGICAL	F2B22B/DL001Z	Study intervention was administered intramuscularly in Phase 1, at Day 1.
BIOLOGICAL	F2B22C/DL001Z	Study intervention was administered intramuscularly in Phase 1, at Day 1.
BIOLOGICAL	F2B22D/DL001Z	Study intervention was administered intramuscularly in Phase 1, at Day 1.
BIOLOGICAL	F2B22E/DL001Z	Study intervention was administered intramuscularly in Phase 1, at Day 1.
BIOLOGICAL	F2F22A/DL001Z	Study intervention was administered intramuscularly in Phase 1, at Day 1.
BIOLOGICAL	F2F22B/DL001Z	Study intervention was administered intramuscularly in Phase 1, at Day 1.
BIOLOGICAL	F2F22C/DL001Z	Study intervention was administered intramuscularly in Phase 1, at Day 1.
BIOLOGICAL	F2F22D/DL001Z	Study intervention was administered intramuscularly in Phase 1, at Day 1.
BIOLOGICAL	F2F22E/DL001Z	Study intervention was administered intramuscularly in Phase 1, at Day 1.
COMBINATION_PRODUCT	Control 1	Control vaccine was administered intramuscularly in Phase 1, at Day 1.
BIOLOGICAL	F2F23D/DL001Z-NH	Study intervention was administered intramuscularly in Phase 2, at Day 1.
BIOLOGICAL	F2F23A/DL001Z-NH	Study intervention was administered intramuscularly in Phase 2, at Day 1.
BIOLOGICAL	F2F23B/DL001Z-NH	Study intervention was administered intramuscularly in Phase 2, at Day 1.
COMBINATION_PRODUCT	Control 2	Control vaccine was administered intramuscularly in Phase 2, at Day 1.
BIOLOGICAL	F2F23C/DL001Z-NH	Study intervention was administered intramuscularly in Phase 2, at Day 1.
COMBINATION_PRODUCT	Control 3	Control vaccine was administered intramuscularly in Phase 2, at Day 1.
BIOLOGICAL	F2F22F/DL001Z	Study intervention was administered intramuscularly in Phase 1, at Day 1.

Timeline

• Start date: 2023-04-27
• Primary completion: 2024-07-02
• Completion: 2024-12-18
• First posted: 2023-04-21
• Last updated: 2025-07-23
• Results posted: 2025-07-23

Locations

41 sites across 4 countries: United States, Belgium, Canada, South Africa

Regulatory

• FDA-regulated drug study