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Immunogenicity and Safety of Verorab™ in Indian Population
This study is ongoing, but not recruiting participants.
First Received: November 29, 2005   Last Updated: March 31, 2008   History of Changes
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:

  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 IV

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

Resource links provided by NLM:


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

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
Lucknow, India
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: Clinical Trials Sanofi Pasteur MSD
  More Information

Additional Information:
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