Immunogenicity and safety of Rabies Vaccine, adimistered with two different simulated post exposure regimens
- Registration Number
- CTRI/2011/07/001857
- Lead Sponsor
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 250
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
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.
11.Subjects who have cancer disorders excluding nonmelanotic skin cancer.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Outcome Measures: Rabies virus neutralizing antibody (RVNA) geometric mean concentrations (GMCs) compared between the study groups at day 14 using the rapid fluorescent focus inhibition test (RFFIT).Timepoint: day 14
- Secondary Outcome Measures
Name Time Method Safety Endpoints: <br/ ><br>1.AEs will be collected for 7 days following vaccination or until time of next vaccination (whichever occurs sooner). <br/ ><br>2.Medically attended AEs and SAEs will be collected from the time the subject signs the informed consent until he/she stops study participation (day 42) <br/ ><br>Timepoint: 42 days