Immunogenicity and Safety of Verorab™ in Indian Population

NCT00260351 | Completed Phase 4 DMC

• 1 other identifier: RAB28
• Study Type: interventional
• Target: 405
• Locations: 1 country
• Sites: 3

Brief Summary

• 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:
• To describe the immunogenicity profile of each regimen
• To assess the safety of the vaccine in each group.

Conditions

Rabies

Keywords

rabies;; rabies post-exposure;; category III

Outcome Measures

Primary Outcomes (1)

• Immunogenicity: To provide information concerning the immune response of Purified Verocell Rabies Vaccine

  6 months post-vaccination

Study Arms (3)

Group 1

EXPERIMENTAL

Participants on Thai Red Cross, TRC-ID regimen

Biological: Purified Verocell Rabies Vaccine

Group 2

EXPERIMENTAL

Participants on Zagreb-IM regimen

Biological: Purified Verocell Rabies Vaccine

Group 3

EXPERIMENTAL

Participants on Essen-IM regimen.

Biological: Purified Verocell Rabies Vaccine

Interventions

Purified Verocell Rabies Vaccine BIOLOGICAL

0.1 mL, ID (TRC regimen)

Also known as: PVRV, VERORAB

Group 1

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject with WHO category III rabies exposure
• Subject aged at least 2 years old (day of second birthday)

You may not qualify if:

• Subject unable to comply with the follow-up schedule of the protocol
• Delayed post-exposure treatment (\>72 hours between incident and treatment
• Subject with immune-compromised or underlying diseases which may lead to inferior immune response
• 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

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (3)

Unknown Facility

Hyderabad, India

Location

Unknown Facility

Kolkata, India

Location

Unknown Facility

Lucknow, India

Location

Related Links

• Related Info

MeSH Terms

Conditions

Rabies

Condition Hierarchy (Ancestors)

Rhabdoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Medical Director

  Sanofi Pasteur Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2005
• First Posted: December 1, 2005
• Study Start: December 1, 2004
• Primary Completion: August 1, 2008
• Study Completion: October 1, 2008
• Last Updated: January 14, 2014

Record last verified: 2014-01

Locations

IN (3)