CTRI/2017/07/008976
Completed
Phase 3
Clinical Trial Protocol for Evaluation of Immunogenicity and Safety of Rabies Vaccine Human (Cell Culture) I.P. in post exposure subjects
Biomed Private Limited0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Biomed Private Limited
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
- •6\. Pregnant women.
- •7\.Infants and children \<\=2 years of age.
Outcomes
Primary Outcomes
Not specified
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