drugset / Trial / NCT07071558
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
RandomizedParallel-groupTriple-blindPrevention
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.
Timeline
- Start
- 2025-07-14
- Primary completion
- 2026-03-17
- Completion
- 2026-03-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | RSV vaccine formulation 1 | Unknown | — | Intramuscular |
| Subject | RSV vaccine formulation 2 | Unknown | — | Intramuscular |
| Subject | RSV vaccine formulation 3 | Unknown | — | Intramuscular |
| Subject | RSV vaccine formulation 4 | Unknown | — | Intramuscular |
| Subject | RSV vaccine formulation 5 | Unknown | — | Intramuscular |
| Subject | RSV vaccine formulation 6 | Unknown | — | Intramuscular |
| Subject | RSV vaccine formulation 7 | Unknown | — | Intramuscular |
| Subject | RSV vaccine formulation 8 | Unknown | — | Intramuscular |