Trials / Active Not Recruiting
Active Not RecruitingNCT06727058
Study to Evaluate Safety and Immunogenicity of a Pandemic Flu H5 mRNA Vaccine in Healthy Adults Aged 18 Years and Older
A Phase 1/2, Randomized, Modified Double-blind, Placebo-controlled, Multi-center, Dose Escalating Study to Evaluate the Safety and Immunogenicity of a Pandemic Flu H5 mRNA Vaccine in Healthy Adults Aged 18 Years and Older
- Status
- Active Not Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 276 (actual)
- Sponsor
- Sanofi Pasteur, a Sanofi Company · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to evaluate a pandemic flu H5 strain messenger ribonucleic acid (mRNA) vaccine at 3 dose levels (low, medium, and high) in comparison with placebo in 276 healthy adult participants to select the adequate dose for further clinical development. The duration per participant will be approximately 13 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Pandemic flu H5 mRNA vaccine | Pharmaceutical Form: Suspension for injection Route of Administration: Intramuscular (IM) |
| OTHER | Placebo | Pharmaceutical Form: Liquid solution for injection Route of Administration: Intramuscular (IM) |
Timeline
- Start date
- 2024-12-09
- Primary completion
- 2026-03-31
- Completion
- 2026-03-31
- First posted
- 2024-12-10
- Last updated
- 2026-01-21
Locations
14 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06727058. Inclusion in this directory is not an endorsement.