Health Condition 1: null- Rabies Infection Health Condition 2: A829- Rabies, unspecified
Conditions
Interventions
Intervention1: Rabimabs: Dose:-RABIMABs (40 IU/Kg) + Vaxirab N (1 mL)
Route:-Intramuscular for RABIMABs and Vaxirab
Dosing during study:Day 0 for RABIMABs and
Day 0,Day 3, Day 7, Day 14 and Day 28 for
Sponsors
Cadila Healthcare Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and Female patients aged 5 years or more than 5 years. 2.WHO Category III exposure(s) by a suspected rabid animal. 3.Have documented informed consent from individuals, the childâ??s parent(s) or legal guardian(s) and assent from the child if appropriate. 4.Free of obvious health problems as determined by history and examination. 5.If female, not pregnant or lactating at the time of enrolment and not planning pregnancy during the vaccination period. 6.Male subjects must be agree to use at least one effective contraceptive method throughout the entire duration of the study.
Exclusion criteria
Exclusion criteria: 1.Pregnant and lactating women. 2.Patient has received any dose of rabies vaccines / rabies immunoglobulin in the past. 3.Allergic to any of the vaccine component / human rabies immunoglobulin components. 4.Chronic administration of immunosuppressants or other immune-modifying agents. 5.Unable to follow all required study procedures for the whole period of the study. 6.Acute febrile illness or acute infectious disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a. Proportion of subjects with RFFIT titre more than or equal to 0.5 IU/ml on Days 14 who receiving RABIMABs + Vaxirab N and Immunoglobulins (Imogam®) + Vaxirab N Timepoint: 14 days | — |
Secondary
| Measure | Time frame |
|---|---|
| a. Proportion of subjects with RFFIT titre more than or equal to 0.5 IU/ml on Days 28, 42 and 84 Timepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactDr Deven Parmar
Cadila Healthcare Limited
Outcome results
None listed