Health Condition 1: null- Dog bite victims
Conditions
Interventions
Intervention1: Vaxirab N: Injecting 0.1ml vaccine on 2 sites over deltoid region intradermally on Days 0,3,7 and 28 as per updated TRC schedule
Control Intervention1: Rabipur: Purified chick embryo ce
Sponsors
NIL
Eligibility
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Safety of new indigenously produced purified chick embryo cell rabies vaccineTimepoint: Days 0,3,7,14 & 28 | — |
Countries
India
Contacts
Public ContactDr Ravish H S
KIMS, Bangalore
Outcome results
None listed