Status:
COMPLETED
Immunogenicity and Safety of Verorab™ in Indian Population
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Rabies
Eligibility:
All Genders
2+ years
Phase:
PHASE4
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 te...
Eligibility Criteria
Inclusion
- Subject with WHO category III rabies exposure
- Subject aged at least 2 years old (day of second birthday)
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
405 Patients enrolled
Trial Details
Trial ID
NCT00260351
Start Date
December 1 2004
End Date
October 1 2008
Last Update
January 14 2014
Active Locations (3)
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1
Hyderabad, India
2
Kolkata, India
3
Lucknow, India