VAD00001: Respiratory Syncytial Virus (RSV) Study

  • STATUS
    Not Recruiting
  • End date
    Apr 18, 2023
  • participants needed
    300
  • sponsor
    Sanofi Pasteur, a Sanofi Company
Updated on 13 June 2022
Accepts healthy volunteers

Summary

The primary objectives of the study are:
  • 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 neutralizing antibody serostatus.
  • To characterize the RSV-A serum neutralizing antibody responses to the study product in each vaccine group after vaccination in Respiratory Syncytial Virus (RSV) seronegative participants.
The secondary objectives of the study are:
  • To quantify the amount of vaccine virus shed by each participant by baseline neutralizing antibody serostatus.
  • To determine the proportion of vaccinated infants and toddlers in each vaccine group infected with the vaccine virus after vaccination by baseline neutralizing antibody serostatus.
  • To characterize the RSV-A serum neutralizing antibody responses to the study product in each vaccine group after vaccination in RSV seropositive participants.
  • To characterize serum RSV-A anti-F immunoglobulin G antibody responses to the study product in each vaccine group after vaccination by baseline neutralizing antibody serostatus.
  • To characterize serum RSV-A antibody responses (neutralizing and anti-F immunoglobulin G) to the study product in each vaccine group after the RSV season by baseline neutralizing antibody serostatus.

Description

Study duration per participant is maximum 12 months

Details
Condition rsv infection, Respiratory syncytial virus infection
Treatment Placebo, RSV vaccine formulation 1, RSV vaccine formulation 2
Clinical Study IdentifierNCT04491877
SponsorSanofi Pasteur, a Sanofi Company
Last Modified on13 June 2022

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