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Study of an Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers — VAD00001  

Respiratory Syncytial Virus Infection Clinical Trial

Official title:
Safety, Immunogenicity, Infectivity, and Dose-Finding Study of an Investigational Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccine in Infants and Toddlers

Clinical Trial Summary

The primary objectives of the study were: - To assess the safety profile of each dose of the study product after each and any administration in all infants and toddlers regardless of baseline serostatus. - To characterize the Respiratory Syncytial Virus (RSV) A serum neutralizing antibody responses to the study product in each vaccine group after vaccination in RSV-naïve participants. The secondary objectives of the study were: - To quantify the amount of vaccine virus shed by each participant by baseline serostatus. - To determine the proportion of vaccinated infants and toddlers in each vaccine group infected with the vaccine virus at D56 (56 days after vaccination 1) for Cohorts 1, 2, 3 and 4, and at Day 84 (28 days after vaccination 2) for Cohorts 2 and 4 by baseline serostatus. - To characterize the RSV A serum neutralizing antibody responses to the study product in each vaccine group after vaccination in RSV-experienced participants. - To characterize serum RSV anti-F immunoglobulin G (IgG) antibody responses to the study product in each vaccine group after vaccination by baseline serostatus. - To characterize serum RSV antibody responses (RSV A-neutralizing and anti-RSV F IgG) to the study product in each vaccine group after the RSV surveillance season or at least 5 months after the last vaccine administration by baseline serostatus.

Clinical Trial Description

Study duration per participant was maximum 12 months ;

Study Design

Related Conditions & MeSH terms

  • Respiratory Syncytial Virus Infection
  • Respiratory Syncytial Virus Infections
Clinical Trial Details
NCT number NCT04491877
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 1/Phase 2
Start date September 17, 2020
Completion date April 13, 2023
View Details
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