drugset / Trial / NCT00260351

Immunogenicity and Safety of Verorab™ in Indian Population

NCT00260351

Phase 4 Completed 405 enrolled Sanofi Pasteur, a Sanofi Company
RandomizedParallel-groupOpen-labelTreatment

Summary

* 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.

Timeline

Start
2004-12
Primary completion
2008-08
Completion
2008-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Purified Verocell Rabies Vaccine Vaccine 0.1 ml Other
Subject Purified Verocell Rabies Vaccine Vaccine 0.5 ml Other

Indications