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Comparison of Rabies Vaccine Regimens (TRC-ID, Zagreb-IM, Essen-IM)
NCT00260351Phase 4
Key facts
- Status
- Completed
- Start
- Dec 2004
- Primary completion
- Aug 2008
- Countries
- 1
- Sponsor
- Sanofi
- Modality
- Recombinant Proteins and Enzymes, Vaccines & Immunotherapeutics
- Conditions
- rabies
01
Overview
Phase 4, randomised, open-label trial of rabies virus inactivated antigen, A in rabies (3 arms), sponsored by Sanofi. Primary endpoint: Geometric Mean Titers at Day 28. Started Dec 2004; status: completed.
02
Design
3 arms- Study design
- RandomizedOpen-label
TRC-ID
Verorab 0.1 mL ID (2-2-2-0-1-1 regimen)
Zagreb-IM
Verorab 0.5 mL IM (2-1-1 regimen)
Essen-IM
Verorab 0.5 mL IM (Standard Essen regimen)
03
Who it enrols
Subjects with WHO category III rabies exposure aged at least 2 years, excluding those with previous rabies immunization, immunosuppressive conditions/treatments, or pregnancy.
04
Endpoints
Primary
Geometric Mean Titers
Secondary
Immunogenicity Profile
Safety Assessment
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