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Study to Evaluate the Safety and the Immunogenicity of a Second Generation Structurally Designed mRNA Vaccine Candidate Against Pandemic Influenza H5 HA Strain in Healthy Adult Participants Aged 18 Years and Older
Sponsor: Sanofi
Summary
The purpose of this phase 1/2 study is to investigate the safety and immunogenicity of different doses (high, medium and low) of a second generation structurally designed (SD2) H5 messenger ribonucleic acid (mRNA) vaccine against pandemic H5 influenza virus (pandemic flu H5 hemagglutinin (HA) mRNA SD2) in healthy younger and older adults. The study will aim to identify the appropriate dose for further clinical development of a potential pandemic response vaccine. The study also includes an extension phase for one of the 3 dose levels of the pandemic flu H5 HA mRNA SD2 vaccine to collect additional safety and the immunogenicity data for this specific dose of the vaccine. During this Extension Phase, an additional 480 participants will be randomized according to a 1:1 ratio and stratified by age (≥ 18 to \< 65 years and ≥ 65 years) to receive either the low dose of the pandemic flu H5 HA mRNA DS2 vaccine (Group 1) or placebo (Group 4). This extension will enhance the safety database and improve precision of the immunogenicity results for the selected dose while preserving the original study design integrity. The study duration per participant will be approximately 13 months. There will be two injections of placebo or pandemic flu H5 mRNA vaccine 21 days apart at high, medium and low doses. Study visits/contact include: 7 study visits and 1 telephone call. Vaccination visits (including blood samples) will occur at Day 01 and Day 22. Short-term follow-up visits (including blood samples) will occur 8 and 21 days after each injection. Participants will be also followed up (including blood samples) at 3 and 6 months after 2nd injection, and at 12 months after 2nd injection for safety.
Official title: A Phase 1/2, Parallel-group, Randomized, Modified Double-blind, Placebo-controlled, Multi-center, Dose Ranging Study to Evaluate the Safety and Immunogenicity of a Second Generation Structurally Designed Pandemic Influenza H5 HA mRNA Vaccine in Healthy Adults Aged 18 Years and Older
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
720
Start Date
2025-04-17
Completion Date
2026-12-01
Last Updated
2026-01-16
Healthy Volunteers
Yes
Interventions
Pandemic flu H5 HA mRNA SD2 vaccine
Pharmaceutical Form: Suspension in a vial Route of Administration: Intramuscular injection
Placebo
Pharmaceutical Form: Liquid solution in a vial Route of Administration: Intramuscular injection
Locations (13)
Velocity Clinical Research - San Diego- Site Number : 8400013
La Mesa, California, United States
Accel Research Sites Network - DeLand Clinical Research Unit- Site Number : 8400002
DeLand, Florida, United States
Accel Research Sites - Lakeland Clinical Research Unit- Site Number : 8400006
Lakeland, Florida, United States
Accel Research Sites - St. Petersburg - Largo- Site Number : 8400004
Largo, Florida, United States
Accel Research Site - NeuroStudies.net, LLC - ERN - PPDS- Site Number : 8400003
Decatur, Georgia, United States
QUEST Research Institute- Site Number : 8400014
Bingham Farms, Michigan, United States
Velocity Clinical Research - Norfolk- Site Number : 8400015
Norfolk, Nebraska, United States
Velocity Clinical Research - Omaha- Site Number : 8400012
Omaha, Nebraska, United States
Velocity Clinical Research - Springdale- Site Number : 8400010
Cincinnati, Ohio, United States
Coastal Carolina Research Center- Site Number : 8400001
North Charleston, South Carolina, United States
Olympus Clinical Research - Sugar Land- Site Number : 8400009
Sugar Land, Texas, United States
Velocity Clinical Research - Salt Lake City- Site Number : 8400011
West Jordan, Utah, United States
Charlottesville Medical Research- Site Number : 8400005
Charlottesville, Virginia, United States