NCT06907511

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

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

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 720 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pandemic Influenza Immunization
• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	Pandemic flu H5 HA mRNA SD2 vaccine	Pharmaceutical Form: Suspension in a vial Route of Administration: Intramuscular injection
OTHER	Placebo	Pharmaceutical Form: Liquid solution in a vial Route of Administration: Intramuscular injection

Timeline

• Start date: 2025-04-17
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-04-02
• Last updated: 2026-01-16

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study