Trials / Active Not Recruiting
Active Not RecruitingNCT07071558
Study to Evaluate the Safety and Immunogenicity of Investigational Vaccines Using the RSV (Respiratory Syncytial Virus) Monovalent Antigen in Healthy Participants 18 to 49 Years of Age
A Phase 1, Parallel, Randomized, Multi-center Study to Evaluate the Safety and Immunogenicity of Different LNP Formulations of mRNA Vaccines Using the RSV Monovalent Antigen in Healthy Participants 18 to 49 Years of Age
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 240 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years – 49 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to evaluate the safety and immunogenicity of different liponanaoparticle (LNP) formulations of modified ribonucleic acid (mRNA) vaccines using the RSV pre-F antigen in healthy participants 18 to 49 years of age. -Each participant will remain in the study for approximately 6 months. * The study intervention will be administered as a single intramuscular (IM) dose in the upper arm on Day 1 (D01). * The visit frequency will include 1 Screening Visit, 4 planned site visits to occur on D01, D03, D08, and D29, and 2 telephone calls to occur at Month (M)3 and M6.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | RSV vaccine formulation 1 dose | Suspension for injection. Route of administration: IM injection |
| BIOLOGICAL | RSV vaccine formulation 2 dose | Suspension for injection. Route of administration: IM injection |
| BIOLOGICAL | RSV vaccine formulation 3 dose | Suspension for injection. Route of administration: IM injection |
| BIOLOGICAL | RSV vaccine formulation 4 dose | Suspension for injection. Route of administration: IM injection |
| BIOLOGICAL | RSV vaccine formulation 5 dose | Suspension for injection. Route of administration: IM injection |
| BIOLOGICAL | RSV vaccine formulation 6 dose | Suspension for injection. Route of administration: IM injection |
| BIOLOGICAL | RSV vaccine formulation 7 dose | Suspension for injection. Route of administration: IM injection |
| BIOLOGICAL | RSV vaccine formulation 8 dose | Suspension for injection. Route of administration: IM injection |
Timeline
- Start date
- 2025-07-14
- Primary completion
- 2026-02-26
- Completion
- 2026-02-26
- First posted
- 2025-07-17
- Last updated
- 2025-09-16
Locations
6 sites across 1 country: Australia
Source: ClinicalTrials.gov record NCT07071558. Inclusion in this directory is not an endorsement.