NCT00260351

Immunogenicity and Safety of Verorab™ in Indian Population

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 405 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rabies

Interventions

Type	Name	Description
BIOLOGICAL	Purified Verocell Rabies Vaccine	0.1 mL, ID (TRC regimen)
BIOLOGICAL	Purified Verocell Rabies Vaccine	0.5 mL, IM (ZAGREB regimen)
BIOLOGICAL	Purified Verocell Rabies Vaccine	0.5 mL, IM (ESSEN regimen)

Timeline

• Start date: 2004-12-01
• Primary completion: 2008-08-01
• Completion: 2008-10-01
• First posted: 2005-12-01
• Last updated: 2014-01-14

Locations

3 sites across 1 country: India