NCT06382311

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

A PHASE 1/2, RANDOMIZED, PARTIALLY-BLIND, DOSE-FINDING/DOSE-CONFIRMATION STUDY TO EVALUATE THE SAFETY, REACTOGENICITY AND IMMUNOGENICITY OF THE MRNA-BASED INVESTIGATIONAL PANDEMIC H5 INFLUENZA VACCINE CANDIDATE ADMINISTERED IN HEALTHY YOUNGER AND OLDER ADULTS

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 991 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to evaluate the safety, reactogenicity and immunogenicity of the Flu Pandemic messenger RNA (mRNA) vaccine (including dose-finding and dose-confirmation) administered in healthy adults 18 to 85 years of age.

Detailed description

Phase 1 (Ph1) of the study aims to evaluate the reactogenicity, safety, and immunogenicity of 5 dose levels of the investigational vaccine, compared with a placebo, in both younger adults (YA) and older adults (OA). Participants will receive two doses, 21 days apart, with safety data collected up to Day 29. The data from this phase will support the safety evaluation of the assessed dose levels and enable further assessment in higher number of participants in Phase 2 Part A. Phase 2 (Ph2) Part A will assess the immunogenicity, reactogenicity, and safety of the same 5 dose levels evaluated in Phase 1, with the aim of identifying the doses to proceed to Phase 2 Part B. Phase 2 Part B will descriptively characterize the dose level of the Flu Pandemic mRNA vaccine candidate selected from Phase 2 Part A, comparing it to an influenza vaccine in a 2-dose schedule. It will also assess safety, reactogenicity, and the immune response induced by the influenza vaccine.

Conditions

• Influenza, Human

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-04-18
• Primary completion: 2026-01-13
• Completion: 2026-01-13
• First posted: 2024-04-24
• Last updated: 2026-02-05

Locations

21 sites across 1 country: United States

Regulatory

• FDA-regulated drug study