Clinical trial NCT00260351: Immunogenicity and Safety of Verorab™ in Indian Population
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rabies
Keywords: rabies;
rabies post-exposure;
category III
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-12-01
Enrollment: 405
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Immunogenicity: To provide information concerning the immune response of Purified Verocell Rabies Vaccine
timeFrame: 6 months post-vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Calcutta
country: India
city: Hyderabad
country: India
city: Lucknow
country: India
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: