Efficacy, Immunogenicity, and Safety Study of a Respiratory Syncytial Virus Vaccine in Infants and Toddlers

  • STATUS
    Not Recruiting
  • End date
    Dec 7, 2027
  • participants needed
    6300
  • sponsor
    Sanofi Pasteur, a Sanofi Company
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Updated on 14 February 2025
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Accepts healthy volunteers

Summary

This study is a phase III, randomized, observer-blind, placebo-controlled, multinational, multi-center study to be conducted in approximately 6300 children 6 months to < 22 months of age. The purpose of the study is to evaluate the efficacy, immunogenicity, and safety of Respiratory Syncytial Virus Toddler (RSVt) vaccine administered by intranasal route compared to placebo.

Eligible participants will be randomized in a 1:1 ratio to receive 2 intranasal administrations of either the RSVt vaccine or placebo.

Study duration will be 24 months for each participant. The safety follow-up will start after the first vaccination and up to the end of the study.

Description

Study duration will be 24 months for each participant. The safety follow-up will start at inclusion and up to the end of the study.

Details
Condition RSV Immunisation
Age 6months - 21months
Treatment Placebo, RSVt Vaccine
Clinical Study IdentifierNCT06252285
SponsorSanofi Pasteur, a Sanofi Company
Last Modified on14 February 2025

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