Rabies Clinical Trial
Official title:
Immunogenicity and Safety of Purified Vero Cell Rabies Vaccine (PVRV, Verorab™) Administered for Rabies Post-exposure Treatment. Comparison of Essen-IM, Zagreb-IM, and Thai Red Cross (TRC)-ID Regimens in the Indian Population.
- To demonstrate that rabies vaccine administered according to the Thai Red Cross,
(TRC)-ID regimen (2-2-2-0-1-1) is not inferior to rabies vaccine administered according
to the ESSEN IM regimen in terms of Geometric Mean Titers (GMTs) at D28, in subjects
with a WHO category III rabies exposure,or,
- To demonstrate that Rabies vaccine administered according to the ZAGREB-IM regimen
(2-1-1) is not inferior to Rabies vaccine administered according to the ESSEN IM
regimen in terms of GMTs at D28, in subjects with a WHO category III rabies exposure.
Secondary objectives:
1. To describe the immunogenicity profile of each regimen
2. To assess the safety of the vaccine in each group.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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