Rabies Clinical Trial
Official title:
Immunogenicity of the Purified Vero Rabies Vaccine - Serum Free in Comparison With the Reference Purified Vero Rabies Vaccine in Pre-exposure Use in Healthy Adults
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.
All subjects will receive three vaccinations for primary series and a booster vaccination at 12 months after the first vaccination. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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