Immunogenicity and Safety of Verorab™ in Indian Population
Phase 4
Completed
- Conditions
- Rabies
- Interventions
- Biological: Purified Verocell Rabies Vaccine
- Registration Number
- NCT00260351
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- 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:
1. To describe the immunogenicity profile of each regimen
2. To assess the safety of the vaccine in each group.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 405
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 Purified Verocell Rabies Vaccine Participants on Thai Red Cross, TRC-ID regimen Group 2 Purified Verocell Rabies Vaccine Participants on Zagreb-IM regimen Group 3 Purified Verocell Rabies Vaccine Participants on Essen-IM regimen.
- Primary Outcome Measures
Name Time Method Immunogenicity: To provide information concerning the immune response of Purified Verocell Rabies Vaccine 6 months post-vaccination
- Secondary Outcome Measures
Name Time Method