NCT06382311View on ClinicalTrials.gov

A Study to Find and Confirm the Dose and Assess Safety, Reactogenicity and Immune Response of a Vaccine Against Pandemic H5N1 Influenza Virus in Healthy Younger and Older Adults

PHASE1/PHASE2RecruitingINTERVENTIONAL

Enrollment

996

Participants

Timeline

Start Date

April 18, 2024

Primary Completion Date

August 25, 2025

Study Completion Date

January 16, 2026

Conditions

Influenza, Human

Interventions

BIOLOGICAL

Flu Pandemic mRNA_Dose level 1

2 doses of study intervention are administered to participants intramuscularly.

BIOLOGICAL

Flu Pandemic mRNA_Dose level 2

2 doses of study intervention are administered to participants intramuscularly.

BIOLOGICAL

Flu Pandemic mRNA_ Dose level 3.

2 doses of study intervention are administered to participants intramuscularly.

BIOLOGICAL

Flu Pandemic mRNA_ Dose level 4

2 doses of study intervention are administered to participants intramuscularly.

BIOLOGICAL

Flu Pandemic mRNA_Dose level 5

2 doses of study intervention are administered to participants intramuscularly.

BIOLOGICAL

Flu Pandemic mRNA_Dose level 6

2 dose of study intervention is administered to participants intramuscularly.

BIOLOGICAL

Influenza virus vaccine

2 doses of Influenza virus vaccine are administered to participants intramuscularly.

DRUG

Placebo

2 doses of Placebo are administered intramuscularly to participants in Phase 1 and Phase 2 Part A and 2 dose is administered to participants in Phase 2 Part B.

Trial Locations (21)

14609

RECRUITING

GSK Investigational Site, Rochester

19111

RECRUITING

GSK Investigational Site, Philadelphia

23502

RECRUITING

GSK Investigational Site, Norfolk

27103

RECRUITING

GSK Investigational Site, Winston-Salem

27405

RECRUITING

GSK Investigational Site, Greensboro

30043

RECRUITING

GSK Investigational Site, Chamblee

33409

RECRUITING

GSK Investigational Site, West Palm Beach

33912

RECRUITING

GSK Investigational Site, Fort Myers

36207

RECRUITING

GSK Investigational Site, Anniston

40509

RECRUITING

GSK Investigational Site, Lexington

64114

RECRUITING

GSK Investigational Site, Kansas City

66219

RECRUITING

GSK Investigational Site, Lenexa

67042

RECRUITING

GSK Investigational Site, El Dorado

68144

RECRUITING

GSK Investigational Site, Omaha

72204

RECRUITING

GSK Investigational Site, Little Rock

73013

RECRUITING

GSK Investigational Site, Edmond

73099

RECRUITING

GSK Investigational Site, Yukon

78705

RECRUITING

GSK Investigational Site, Austin

80525

RECRUITING

GSK Investigational Site, Fort Collins

89102

RECRUITING

GSK Investigational Site, Las Vegas

98104

RECRUITING

GSK Investigational Site, Seattle

Sponsors

Lead Sponsor

GlaxoSmithKline

All Listed Sponsors

lead

GlaxoSmithKline

INDUSTRY