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Immunogenicity and Safety of Verorab™ in Indian Population

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Disease Information

Descriptive Information
Brief Title † Immunogenicity and Safety of Verorab™ in Indian Population
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.
Brief 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.
Detailed Description
Study Phase Phase 4
Study Type † Interventional
Study Design † Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary Outcome Measure † Immunogenicity: To provide information concerning the immune response of Purified Verocell Rabies Vaccine
Secondary Outcome Measure †
Condition † Rabies
Intervention † BiologicalPurified Verocell Rabies Vaccine
Study Arms / Comparison Groups Group 1 Participants on Thai Red Cross, TRC-ID regimen Group 2 Participants on Zagreb-IM regimen Group 3 Participants on Essen-IM regimen.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Biological
Estimated Enrollment † 405
Start Date † December 2004
Completion Date October 2008
Primary Completion Date August 2008
Eligibility Criteria † Inclusion Criteria: - Subject with WHO category III rabies exposure - Subject aged at least 2 years old (day of second birthday) Exclusion Criteria: - Subject unable to comply with the follow-up schedule of the protocol - Delayed post-exposure treatment (>72 hours between incident and treatment - Subject bitten by an observable animal at the inclusion visit - Subject with immune-compromised or underlying diseases which may lead to inferior immune response - Subject with known pregnancy at the time of inclusion - Subject enrolled or scheduled to be enrolled in another clinical study. - Subject with acute febrile illness/ axillary temperature > 37.5 degree celsius - Subject in whom blood sampling will be difficult. - Subject receiving chloroquine or other anti-malarial treatment - Subject receiving immunosuppressive therapy, other immune-modifying drug or cytotoxic drugs - Subject with known chronic illnesses (ie. heart, lung, kidney, liver) including immunosuppressive diseases (cancer, HIV, etc.) - Previous rabies immunization - Subject having received any vaccine within the previous 30 days, except tetanus toxoid and tetanus immunoglobulin - Subject with clinical signs of rabies - Subject with known allergy to vaccine components (e.g. neomycin) - Subject who received blood and/or plasma transfusion within the past 3 months
Gender Both
Ages 2 Years - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries † India
Administrative Information
NCT ID † NCT00260351
Organization ID RAB28
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † Sanofi Pasteur, a Sanofi Company
Collaborators ††
Investigators † Study Director: Medical Director, Sanofi Pasteur Inc.
Information Provided By
Verification Date January 2014
First Received Date † November 29, 2005
Last Updated Date January 10, 2014
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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