Clinical Trial: Immunogenicity and Safety of a Purified Vero Rabies Vaccine

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Immunogenicity and Safety of a Purified Vero Rabies Vaccine Serum Free When Administered According to a Simulated Rabies Post Exposure Regimen

Brief Summary: This multicenter, observer-blind, controlled, randomized, Phase II study was designed to evaluate different formulations of the Purified Vero Rabies Cell vaccine VRVg.

Detailed Summary: This study will assess different formulations of the modified formulation of VRVg (VRVg 2) to be tested in parallel to the initial VRVg formulation (VRVg 1) and Imovax rabies. Immune responses will be assessed at Day 14, Day 28, Day 42, and at Month 7. Safety events will also be reported.
Sponsor: Sanofi

Current Primary Outcome:

• Summary of rabies virus neutralizing antibody (RVNA) titers against rabies virus assessed by the rapid fluorescent focus inhibition test (RFFIT) [ Time Frame: Month 7 post vaccination ]
  Change in RVNA titers from Day 0 (before vaccination) up to Month 7 in all participants
• Percentage of participants with complete neutralization at the starting dilution (1/5) of the RFFIT assay at each timepoint [ Time Frame: Month 7 post vaccination ]
  Participants with complete neutralization
• Percentage of participants with solicited injection site and systemic reactions [ Time Frame: Day 7 post each injection ]
  Percentage of patients with solicited injection site and systemic reactions starting on day of vaccination through Day 7 post each vaccination.

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Sanofi

Dates:
Date Received: May 3, 2017
Date Started: April 17, 2017
Date Completion: March 2018
Last Updated: May 5, 2017
Last Verified: May 2017