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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Mononegavirales Infections
Rhabdoviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 20, 2014