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
NCT06382311 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 991
Last updated 2026-02-05
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.
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
-
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.
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-04-18
- Primary Completion
- 2026-01-13
- Completion
- 2026-01-13
- FDA Drug
- Yes
Countries
- United States
Study Locations
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