Immunogenicity and Safety of Verorab™ in Indian Population

January 10, 2014 updated by: Sanofi Pasteur, a Sanofi Company

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.

  • 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

405

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Calcutta, India
      • Hyderabad, India
      • Lucknow, India

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Participants on Thai Red Cross, TRC-ID regimen
Biological: Purified Verocell Rabies Vaccine
0.1 mL, ID (TRC regimen)
Other Names:
  • PVRV, VERORAB
Biological: Purified Verocell Rabies Vaccine
0.5 mL, IM (ZAGREB regimen)
Other Names:
  • PVRV, VERORAB
Biological: Purified Verocell Rabies Vaccine
0.5 mL, IM (ESSEN regimen)
Other Names:
  • PVRV, VERORAB
Experimental: Group 2
Participants on Zagreb-IM regimen
Biological: Purified Verocell Rabies Vaccine
0.1 mL, ID (TRC regimen)
Other Names:
  • PVRV, VERORAB
Biological: Purified Verocell Rabies Vaccine
0.5 mL, IM (ZAGREB regimen)
Other Names:
  • PVRV, VERORAB
Biological: Purified Verocell Rabies Vaccine
0.5 mL, IM (ESSEN regimen)
Other Names:
  • PVRV, VERORAB
Experimental: Group 3
Participants on Essen-IM regimen.
Biological: Purified Verocell Rabies Vaccine
0.1 mL, ID (TRC regimen)
Other Names:
  • PVRV, VERORAB
Biological: Purified Verocell Rabies Vaccine
0.5 mL, IM (ZAGREB regimen)
Other Names:
  • PVRV, VERORAB
Biological: Purified Verocell Rabies Vaccine
0.5 mL, IM (ESSEN regimen)
Other Names:
  • PVRV, VERORAB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Immunogenicity: To provide information concerning the immune response of Purified Verocell Rabies Vaccine
Time Frame: 6 months post-vaccination
6 months post-vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi Pasteur, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

November 29, 2005

First Submitted That Met QC Criteria

November 29, 2005

First Posted (Estimate)

December 1, 2005

Study Record Updates

Last Update Posted (Estimate)

January 14, 2014

Last Update Submitted That Met QC Criteria

January 10, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RAB28

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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