A Comparative Phase III Clinical Study of Bharat Biotech International Limited Rabies Vaccine INDIRAB reconstituted with 1mL diluent Vs Reference Vaccine, administered Intramuscularly in healthy volunteers as Pre-Exposure treatment.
- Registration Number
- CTRI/2010/091/000214
- Lead Sponsor
- Bharat Biotech International Limited,Genome Valley, Shameerpet,Ranga Reddy (Distict),Hyderabad-500 078.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
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
Exclusion
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.
11.Past history of chronic alcoholic abuse.
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.
11)Past history of chronic alcoholic abuse.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of subjects Seroconverted by Day 35 (WHO specifies a minimum antibody titer of 0.5 IU/ml as protective against rabies virus).Timepoint: On day 0 and 35
- Secondary Outcome Measures
Name Time Method Assessment of solicited and unsolicited Adverse Drug reactions with safety up to 35 days.Timepoint: Through out the study period