CTRI/2012/06/002720
Completed
Phase 4
Clinical evaluation of safety and immunogenicity of an indigenously developed purified chick embryo cell rabies vaccine when administered intradermally in animal bite cases
I0 sites70 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- I
- Enrollment
- 70
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects with low risk Category II and Category III exposures.
- •Subjects willing to give signed informed consent.
- •Subjects willing to give blood samples on recommended days.
- •Subjects available for minimum of 6 months follow\-up.
- •Dog/Cat domesticated, available for 10 days observation, apparently healthy, provoked bite, wound washed with soap and water and consulting for vaccination within 48 hours of exposure.
Exclusion Criteria
- •Pregnancy \& lactation.
- •Subjects who had received any type of rabies vaccine/immunoglobulin in the past.
- •Subjects with very severe bite wounds.
- •Subjects with chronic illness or cancers.
- •Subjects on steroids or any other immunosuppressant or is known to be HIV positive.
- •Subjects planning for surgery in the next 3 month
- •Subjects on concomitant antimalarials.
- •Subjects with history of allergy to any ingredient of the vaccine.
- •Participation in another clinical trial in the past 3 months.
- •Past history of chronic alcoholic abuse.
Outcomes
Primary Outcomes
Not specified
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Unknown
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