None listed
Conditions
Interventions
Intervention1: SURE RAB: Group I: five intramuscular injection of 1ml each on days 0,3,7,14,28.
Group II: Thai Red Cross Rsgimen of intradermal injection of 0.1ml at two location on days 0,3,7,28.
C
Sponsors
Biomed Private Limited
Eligibility
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunogenicity and safety profile will be evaluated and compared with that of the reference vaccine in the study population by estimating the percentage seroconversion.The seroconversion in the subjects will be evaluated.Timepoint: The rabies antibody titers shall be analysed for seroconversion(â?¥ 0.5 IU/ml) | — |
Secondary
| Measure | Time frame |
|---|---|
| NONETimepoint: NONE | — |
Countries
India
Contacts
Public ContactDr SPGarg
Sir Ganga Ram Hospital
Outcome results
None listed