CTRI/2011/07/001857
Completed
Phase 4
A phase IV, multi-center, randomized, open-label study of PCECV (Rabipur®) comparing the immunogenicity and safety of two different simulated post exposure schedules (Zagreb 2-1-1 versus Essen regimen 1-1-1-1-1) in Healthy Indian subjects - Rabipur study
ovartis Healthcare Pvt Ltd0 sites250 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ovartis Healthcare Pvt Ltd
- Enrollment
- 250
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Males and femalesof age greater than and equal to 18 years.
- •2\. Individuals who have given written consent.
- •3\. Individuals in good health and available for all the visits scheduled in the study
Exclusion Criteria
- •1\.Pregnancy or unwillingness to practice acceptable contraception.
- •2\.A history of Rabies immunization.
- •3\.History of allergy to egg protein.
- •4\.Known hypersensitivity to neomycin, or any other vaccine component.
- •5\.A significant acute or chronic infectious disease or use of antibiotics that may impact the subjects safety and /or immunogenicity in the Investigators opinion at the time of enrolment.
- •6\.Body temperature greatr than or equal to 38\.0°C (greater than or equal to 100\.4° F) within 3 days of study vaccination.
- •7\.Treatment with an anti\-malarial drug, up to two months prior to the study.
- •8\.Individuals who received any other vaccines within 28 days prior to enrollment.
- •9\.Subjects who have received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks.
- •10\.Any planned surgery during the study period.
Outcomes
Primary Outcomes
Not specified
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