Phase III Clinical Trial of Rabies Vaccine Human I.P. in post bite subjects.
- Registration Number
- CTRI/2017/07/008976
- Lead Sponsor
- Biomed Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
6. 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.Timepoint: The rabies antibody titers shall be analysed for seroconversion(â?¥ 0.5 IU/ml)
- Secondary Outcome Measures
Name Time Method ONETimepoint: NONE