Immunogenicity and Safety of Verorab™ in Indian Population

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00260351
First received: November 29, 2005
Last updated: January 10, 2014
Last verified: January 2014
  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:

  1. To describe the immunogenicity profile of each regimen
  2. To assess the safety of the vaccine in each group.

Condition Intervention Phase
Rabies
Biological: Purified Verocell Rabies Vaccine
Phase 4

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:


Further study details as provided by Sanofi:

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

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00260351

Locations
India
Calcutta, India
Hyderabad, India
Lucknow, India
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00260351     History of Changes
Other Study ID Numbers: RAB28
Study First Received: November 29, 2005
Last Updated: January 10, 2014
Health Authority: India: Indian Council of Medical Research

Keywords provided by Sanofi:
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 April 17, 2014