Health Condition 1: null- CATEGORY II ANIMAL EXPOSURE SUBJECTS
Conditions
Interventions
Intervention1: Rabies Vaccine, Human I.P. (Purified Vero Cell Rabies Vaccine)-Abhayrab vaccine manufactured by Human Biologicals Institute.: 2-2-2-0-2 (Modified Thai Red Cross Regimen) on days 0, 3, 7
Sponsors
Human Biologicals Institute
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects with Category II Animal Exposure, aged below 70 years. 2. Plans to remain in the study area for the duration of the trial. 3. Subject/ Subjectâ??s Legally Acceptable Representative willing to provide Informed Consent as per ICH â?? GCP guidelines. 4. Written informed consent for participation in the study, obtained prior to screening from Subject/Subjectâ??s Legally Acceptable Representative.
Exclusion criteria
Exclusion criteria: 1. Subjects currently receiving immunosuppressive therapy (including steroids for any indication), allergy immunotherapy or having any known immunodeficient condition (e.g. AIDS, hypogammaglobulinemia etc.) or malignancy. 2. Subjects treated with anti-malarial drug (e.g. chloroquine) in the last 2 months or requiring antimalarial treatment during the study period 3. Subjects suffering from acute febrile illness or allergic reactions including allergy to antibiotics. 4. Subjects with history of or occurrence of seizures at the time of vaccination. 5. Planned participation in another clinical trial during the present trial period. 6. Subjects who have participated in any other clinical trial within the past 3 months. 7. Subjects who have clinical evidence of significant neurological, hematological, hepatic, renal, cardiac, respiratory disease or metabolic illness. 8. Pregnant or nursing women. 9. Subjects with known hypersensitivity to the vaccine or any component of the vaccine. 10. Subjects with history of drug or alcohol abuse. 11. Subjects who received blood and/or plasma transfusion within the past 3 months. 12. Any condition which, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine all the local and systemic adverse events after intradermal administration of Abhayrab Vaccine reconstituted to 1 ml.Timepoint: To determine all the local and systemic adverse events after intradermal administration of Abhayrab Vaccine reconstituted to 1 ml. | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactDr S Sai Krishna
Human Biologicals Institute
Outcome results
None listed