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:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Rabies

Drug Information available for: Rabies Vaccine Rabies Vaccines

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 ]

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

Arms	Assigned Interventions
1: Experimental	Biological: Purified Verocell Rabies Vaccine 0.1 mL, ID (TRC regimen)
2: Experimental	Biological: Purified Verocell Rabies Vaccine 0.5 mL, IM (ZAGREB regimen)
3: Experimental	Biological: Purified Verocell Rabies Vaccine 0.5 mL, IM (ESSEN regimen)

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:

Clinical Trials

Sanofi Pasteur MSD

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Sanofi Pasteur, Inc ( Medical Directoe )
Study ID Numbers:	RAB28
Study First Received:	November 29, 2005
Last Updated:	March 31, 2008
ClinicalTrials.gov Identifier:	NCT00260351 History of Changes
Health Authority:	India: Indian Council of Medical Research

Keywords provided by Sanofi-Aventis:

rabies;
rabies post-exposure;
category III

Additional relevant MeSH terms:

Virus Diseases
RNA Virus Infections
Rabies
Rhabdoviridae Infections
Mononegavirales Infections

ClinicalTrials.gov processed this record on February 08, 2010