Immunogenicity and Safety of Verorab™ in Indian Population
NCT ID: NCT00260351
Last Updated: 2014-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
405 participants
INTERVENTIONAL
2004-12-31
2008-10-31
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1
Participants on Thai Red Cross, TRC-ID regimen
Purified Verocell Rabies Vaccine
0.1 mL, ID (TRC regimen)
Group 2
Participants on Zagreb-IM regimen
Purified Verocell Rabies Vaccine
0.5 mL, IM (ZAGREB regimen)
Group 3
Participants on Essen-IM regimen.
Purified Verocell Rabies Vaccine
0.5 mL, IM (ESSEN regimen)
Interventions
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Purified Verocell Rabies Vaccine
0.1 mL, ID (TRC regimen)
Purified Verocell Rabies Vaccine
0.5 mL, IM (ZAGREB regimen)
Purified Verocell Rabies Vaccine
0.5 mL, IM (ESSEN regimen)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject aged at least 2 years old (day of second birthday)
Exclusion Criteria
* 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
2 Years
ALL
No
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Sanofi Pasteur Inc.
Locations
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Hyderabad, , India
Kolkata, , India
Lucknow, , India
Countries
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Related Links
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Related Info
Other Identifiers
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RAB28
Identifier Type: -
Identifier Source: org_study_id
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