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

Study on Safety and Immune Response of Investigational Vaccines for RSV in Adults

Recruiting
18 years - 49 years
All
Phase 1
240 participants needed
6 Locations

Study Overview

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.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Respiratory Syncytial Virus Immunization
  • Age: 18 years - 49 years
  • Gender: All

Inclusion Criteria:

  • Aged 18 to 49 years on the day of inclusion
  • A female participant is eligible to participate if she is not pregnant or breastfeeding and of the following conditions applies:
    • Is of NCBP (Non-Child-Bearing Potential). To be considered of NCBP, a female must be post-menopausal for at least 1 year, or surgically sterile. OR
    • Is of CBP (Child-Bearing Potential) and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 12 weeks after study intervention administration.

Exclusion Criteria:

  • Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Updated on 17 Aug 2025. Study ID: NCT07071558

This study investigates the safety and immune response of investigational vaccines using the RSV (Respiratory Syncytial Virus) monovalent antigen in healthy adults aged 18 to 49. The purpose is to evaluate different formulations of mRNA vaccines, which use the RSV pre-F antigen, a component designed to trigger an immune response against the virus.

Participants will receive the study vaccine as a single intramuscular injection in the upper arm on the first day. The study includes multiple visits and phone calls to monitor participants' health and immune response. Participants will have one screening visit, followed by four site visits and two telephone check-ins to ensure comprehensive follow-up.

  • Who can participate: Participants must be aged 18 to 49 years. Female participants must not be pregnant or breastfeeding and should either be non-child-bearing or agree to use effective contraception.
  • Study details: Participants will receive a single dose of the investigational vaccine. Follow-up includes site visits and phone calls to monitor safety and immune response.
  • Study timelines and visits: The study will last 6 months. The study requires 4 visits.

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