Clinical Trial

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

Completed Phase 1
View on ClinicalTrials.gov →
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-07-16; most recent amendment 2026-04-24.
Status change: Active, Not Recruiting → Completed 2026-04-24
Status change: Recruiting → Active, Not Recruiting 2025-09-10
Status change: Not Yet Recruiting → Recruiting 2025-08-13
Trial Details
NCT Number NCT07071558
Lead Sponsor Sanofi
Conditions Respiratory Syncytial Virus Immunization
Enrollment 240 participants
Start Date 2025-07-14
Primary Completion 2026-03-17 (estimated)
Study Completion 2026-03-17 (estimated)
Updated on ClinicalTrials.gov 2026-04-28