CTRI/2010/091/000214
Completed
Phase 3
Study to Evaluate the Safety and Immunogenicity of Rabies Vaccine INDIRAB reconstituted with 1mL diluent Vs Reference Vaccine, administered Intramuscularly in healthy volunteers (Pre-Exposure).
Bharat Biotech International Limited,Genome Valley, Shameerpet,Ranga Reddy (Distict),Hyderabad-500 078.0 sites60 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Bharat Biotech International Limited,Genome Valley, Shameerpet,Ranga Reddy (Distict),Hyderabad-500 078.
- Enrollment
- 60
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion Criteria
- •1\.Subject between 18\-55 years of age
- •2\.Subjects willing to give signed informed consent
- •3\.Subjects willing to give blood samples on recommended days
- •4\.Subjects available for follow up period
- •1\.Pregnancy \& Lactation.
- •2\.Subjects who had received any type of rabies vaccination in the past.
- •3\.Subjects who had received rabies immunoglobulin (human / equine) in the past.
- •4\.Subjects who had suffered from any chronic illness or cancers.
- •5\.Subjects on steroids or any other immunosuppressant or is known to be HIV positive.
Exclusion Criteria
- •1\)Pregnancy \& Lactation.
- •2\)Subjects who had received any type of rabies vaccination in the past.
- •3\)Subjects who had received rabies immunoglobulin (human / equine) in the past.
- •4\)Subjects who had suffered from any chronic illness or cancers.
- •5\)Subjects on steroids or any other immunosuppressant or is known to be HIV positive.
- •6\)Subjects planning for surgery in the next 3 months.
- •7\)Subjects on concomitant antimalarials.
- •8\)Subjects with history of allergy to any ingredient of the vaccine.
- •9\)Participation in another clinical trial in the past 3 months.
- •10\)Use of any marketed or investigational or herbal medicine or non registered drug or vaccine for rabies in the past 2 months.
Outcomes
Primary Outcomes
Not specified
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