Immunogenicity and Safety of Verorab™ in Indian Population - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00260351

Purpose

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:

Condition	Intervention	Phase
Rabies	Biological: Purified Verocell Rabies Vaccine	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Rabies

Drug Information available for: Rabies Vaccine Rabies Vaccines

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Immunogenicity: To provide information concerning the immune response of Purified Verocell Rabies Vaccine [ Time Frame: 6 months post-vaccination ] [ Designated as safety issue: No ]

Enrollment:	405
Study Start Date:	December 2004
Study Completion Date:	October 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group 1 Participants on Thai Red Cross, TRC-ID regimen	Biological: Purified Verocell Rabies Vaccine 0.1 mL, ID (TRC regimen) Other Name: PVRV, VERORAB
Experimental: Group 2 Participants on Zagreb-IM regimen	Biological: Purified Verocell Rabies Vaccine 0.5 mL, IM (ZAGREB regimen) Other Name: PVRV, VERORAB
Experimental: Group 3 Participants on Essen-IM regimen.	Biological: Purified Verocell Rabies Vaccine 0.5 mL, IM (ESSEN regimen) Other Name: PVRV, VERORAB

Eligibility

Criteria

Inclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00260351

Locations

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Medical Director

Sanofi Pasteur Inc.

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Medical Directoe, Sanofi Pasteur, Inc
ClinicalTrials.gov Identifier:	NCT00260351 History of Changes
Other Study ID Numbers:	RAB28
Study First Received:	November 29, 2005
Last Updated:	February 22, 2010
Health Authority:	India: Indian Council of Medical Research

Keywords provided by Sanofi-Aventis:

rabies;
rabies post-exposure;
category III

Additional relevant MeSH terms:

Rabies
Rhabdoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on February 09, 2012