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

Sanofi

Status and phase

Active, not recruiting

Phase 1

Conditions

Respiratory Syncytial Virus Immunization

Treatments

Biological: RSV vaccine formulation 5 dose

Biological: RSV vaccine formulation 6 dose

Biological: RSV vaccine formulation 2 dose

Biological: RSV vaccine formulation 8 dose

Biological: RSV vaccine formulation 4 dose

Biological: RSV vaccine formulation 1 dose

Biological: RSV vaccine formulation 3 dose

Biological: RSV vaccine formulation 7 dose

Study type

Interventional

Funder types

Industry

Identifiers

NCT07071558

WHO UTN (Other Identifier)

VAV00026

Details and patient eligibility

About

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.

Enrollment

240 patients

Sex

All

Ages

18 to 49 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

240 participants in 8 patient groups

RSV Formulation 1

Experimental group

Description: