Phase III Clinical Trial of Rabies Vaccine Human I.P. in post bite subjects.

Phase 3

Completed

• Conditions: dog bite volunteers

• Registration Number: CTRI/2017/07/008976
• Lead Sponsor: Biomed Private Limited

Brief Summary

The purpose of this Clinical Trial was to compare Immunogenicity and safety of Rabies Vaccine Sure Rab manufactured by Biomed Private Limited with the Vero Rab manufactured by Aventis Pasteur in post exposure subjects.

Objectives:



1. For Evaluation of Immunogenicity and safety of Rabies Vaccine Human (Cell Culture) I.P. in post exposure subjects.



2. Subjects were divided into three groups:-

1. Group I : Immunized by Essen regimen with Sure Rab.

2. Group II: Immunized by Thai Red Cross regimen Sure Rab.

3. Group III: Immunized by Essen regimen with Vero Rab.

All volunteers of test and comparator vaccine  achieved the protective level on Day 14.

Results were submitted to DCGI and sale permission is granted by DCGI.

Detailed Description

Not available

Study Timeline

• Study Completion: 2017-06-11
• Study Start: 2017-07-15
• Last Update Posted: 2019-11-26

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• 1.Subject is bitten by suspect rabid animal and having either category II or III exposure as assessed by history,physical examination and clinical judgment of the investigator.
• 2.Subject is of age group (2 to 65)years.
• 3.Subject is of Indian origin and will remain in the study area for the length of the trial.
• 4.Subject should accept written and inform consent.
• 5.Subject is aware of full information regarding the vaccine and clinical trial.

Exclusion Criteria

• 1.History of allergy or hypersensitivity to any component of the vaccine.
• 2.History of Rabies immunization.
• 3.Person participating in any other study at the same time or during the past three months.
• 4.Surgery planned during the study period.
• 5.Person known to be HIV positive.
• Pregnant women.
• 7.Infants and children ≤2 years of age.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immunogenicity and safety profile will be evaluated and compared with that of the reference vaccine in the study population by estimating the percentage seroconversion.The seroconversion in the subjects will be evaluated.	The rabies antibody titers shall be analysed for seroconversion(≥ 0.5 IU/ml)

Trial Locations

Locations (1)

Sir Ganga Ram Hospital; 🇮🇳 Delhi, DELHI, India

Sir Ganga Ram Hospital

🇮🇳Delhi, DELHI, India

Dr Atul KakarSenior consultantDepartment of internal medicine

Principal investigator

9811110802

atulkakar@hotmail.com