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Protection and Safety of rabies vaccine when administered intradermally

Phase 4
Completed
Conditions
Health Condition 1: null- Dog bite victims
Registration Number
CTRI/2012/06/002720
Lead Sponsor
I
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
70
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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Immunogenicity of new indigenously produced purified chick embryo cell rabies vaccine when administered intradermallyTimepoint: Rabies Virus Neutralising Antibody estimation on Days 14, 28,90 & 180
Secondary Outcome Measures
NameTimeMethod
Safety of new indigenously produced purified chick embryo cell rabies vaccineTimepoint: Days 0,3,7,14 & 28
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