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.

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).

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000214

Enrollment

Registered

2010-03-15

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Rabies Vaccine INDIRAB manufactured by Bharat Biotech International Limited: Vaccine reconstituted with 1mL diluent and administered intramuscularly on days 0, 7 and 28 Control Interven

Eligibility

Inclusion 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 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.

Exclusion criteria

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. 11)Past history of chronic alcoholic abuse.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Assessment of solicited and unsolicited Adverse Drug reactions with safety up to 35 days.Timepoint: Through out the study period	—

Countries

India

Contacts

Public ContactDr. Santhosh Kumar. M,

Bharat Biotech International Limited,

madhusudhansk@bharatbiotech.com+914023480567

Outcome results