Health Condition 1: Z23- Encounter for immunization
Conditions
Interventions
Intervention1: Purified Chick Embryo Cell Culture Rabies Vaccine. (Each 1.0 ml of reconstituted vaccine contains â?¥ 2.5 I.U. of antigen): 0.1 ml of reconstituted vaccine intradermally per site and on
Sponsors
Cadila Healthcare Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy adult volunteers of either gender aged between 18-55 years. 2. If female, not pregnant or lactating at the time of enrolment and not planning pregnancy during the vaccination period. 3. Subjects likely to be available for all visits during follow-up period. 4. Willing to sign Informed consent.
Exclusion criteria
Exclusion criteria: 1. Pregnancy & Lactation. 2. Subject has received any type of rabies vaccination in the past. 3. Subject has received any dose of rabies immunoglobulin (human/equine) in the past. 4. Subject suffering from any other illness of whatsoever nature 5. Subject is on steroids or any other immunosuppressants or is known to be HIV positive. 6. Subject is planning for surgery in the next 3 months. 7. Subject is on concomitant antimalarials. 8. Subject with history of allergy to any ingredient of the vaccine. 9. Subject not likely to be available for follow-up. 10. Participation in another clinical trial in the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All patients achieving ≥ 0.5 I.U. antibody titre on Day 14, Day 28 & Day 90 will be considered to have developed successful protection by Purified Chick Embryo Rabies Vaccine as per WHO specificationsTimepoint: Day 14, Day 28 & Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| NilTimepoint: Not Applicable | — |
Countries
India
Contacts
Public ContactDr Ravindra Mittal
Outcome results
None listed