A clinical trial to study immunogenicity and safety of Purified Chick Embryo Cell Culture Rabies Vaccine in post-exposure animal bite cases.

An open label multicentric study to assess the immunogenicity and safety of Purified Chick Embryo Cell Culture Vaccine in post-exposure animal bite cases.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000055

Enrollment

100

Registered

2010-02-02

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

Health Condition 1: Z23- Encounter for immunization Health Condition 2: null- Rabies - Post exposure prophylaxis

Interventions

Intervention1: Purified Chick Embryo Cell Culture Rabies Vaccine. Each full I. M. dose of the vaccine (1.0 ml) contains &#8805

2.5 I.U. of antigen per dose of the reconstituted vaccine.: 5 intramuscular (I. M.) doses of 1 unit dose (1.0 ml) of the vaccine on Day 0, Day 3, Day 7, Day 14 and Day 28 in the deltoid muscle Control

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients 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. Patients 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. Patient has received any type of rabies vaccination in the past. 3. Patient has received any dose of rabies immunoglobulin (human/equine) in the past. 4. Patient with a history of suturing of the wound or application of irritants at the wound site. 5. Patient suffering from any other illness of whatsoever nature 6. Patient is on steroids or any other immunosuppressants or is known to be HIV positive. 7. Patient is planning for surgery in the next 3 months. 8. Patient is on concomitant antimalarials. 9. Patient with history of allergy to any ingredient of the vaccine. 10. Patient not likely to be available for follow-up. 11. Participation in another clinical trial in the past 3 months.

Design outcomes

Primary

Measure	Time frame
Patients achieving ≥ 0.5 I.U. antibody titre on Day 14, Day 28, Day 90 & Day 180 will be considered to have developed successful protection as per WHO specifications.Timepoint: Day 14,28,90 & 180	—

Secondary

Measure	Time frame
NoneTimepoint: Not Applicable	—

Countries

India

Contacts

Public ContactDr Ravindra Mittal

Cadila Healthcare Ltd.

r.mittal@zyduscadila.com07926868926

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026