Study of Purified Vero Rabies Vaccine Serum Free Compared With Reference Purified Vero Rabies Vaccine in Healthy Adults
- Conditions
- Rabies
- Interventions
- Biological: Purified Vero Rabies Vaccine - Serum FreeBiological: Purified inactivated rabies vaccine
- Registration Number
- NCT00948272
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- 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 Description
All subjects will receive three vaccinations for primary series and a booster vaccination at 12 months after the first vaccination.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 384
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VRVg Group Purified Vero Rabies Vaccine - Serum Free - Verorab Group Purified inactivated rabies vaccine -
- Primary Outcome Measures
Name Time Method To provide information concerning the immunogenicity of Purified Vero Rabies Vaccine. 42 days post-primary series vaccination
- Secondary Outcome Measures
Name Time Method To provide information concerning the safety after Purified Vero Rabies Vaccine. 0 to 7 days post-vaccination and entire study duration