Clinical Trial: Study of Purified Vero Rabies Vaccine Serum Free Compared With Reference Purified Vero Rabies Vaccine in Healthy Adults
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Immunogenicity of the Purified Vero Rabies Vaccine - Serum Free in Comparison With the Reference Purified Vero Rabies Vaccine in Pre-exposure
Brief Summary:
The purpose of this study is to generate data in human on immunogenicity and safety of Purified Vero Rabies Vaccine (VRVg) in support of the vaccine registration.
Primary Objective:
- To demonstrate that VRVg is at least as immunogenic as the reference vaccine, Verorab, in terms of seroconversion rate at Day 42 of the primary vaccination series.
Secondary Objectives:
- To assess the clinical safety of VRVg after each vaccination when administered in a pre-exposure vaccination schedule with a booster at 12 months after the first vaccination in all subjects.
- To describe the immune response induced by VRVg 21 days after two vaccinations in a subset of randomized subjects and 14 days after the last vaccination of the primary vaccination series.
Detailed Summary: All subjects will receive three vaccinations for primary series and a booster vaccination at 12 months after the first vaccination.
Sponsor: Sanofi Pasteur, a Sanofi Company
Current Primary Outcome: To provide information concerning the immunogenicity of Purified Vero Rabies Vaccine. [ Time Frame: 42 days post-primary series vaccination ]
Original Primary Outcome: Same as current
Current Secondary Outcome: To provide information concerning the safety after Purified Vero Rabies Vaccine. [ Time Frame: 0 to 7 days post-vaccination and entire study duration ]
Original Secondary Outcome: Same as current
Information By: Sanofi
Dates:
Date Received: July 28, 2009
Date Started: July 2009
Date Completion:
Last Updated: May 27, 2014
Last Verified: May 2014
