Health Condition 1: A829- Rabies, unspecified
Conditions
Interventions
Intervention1: Rabishield and Rabivax-S: Rabishield:
Rabishield is supplied as 2.5 ml vials containing not less than 40 IU/ml.
Manufactured by Serum Institute of India Pvt. Ltd., Pune, India.
Rabiv
Sponsors
Serum Institute of India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients aged more than 2 years of either sex 2. WHO Category III exposure(s) by a suspected rabid animal 3. Written informed consent by subjects (>=18 years) / parents of subjects (2-17 years). 4. Written informed assent by subjects aged 7-17 years
Exclusion criteria
Exclusion criteria: 1. Previous receipt of complete PEP or pre-exposure prophylaxis with modern cell culture rabies vaccine. 2. Acute or chronic, clinically significant pulmonary, endocrine, autoimmune, psychiatric, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination, which in the opinion of the investigator might interfere with the study objectives. 3. Major congenital defects or serious chronic illness. 4. History of thrombocytopenia or known bleeding disorders. 5. Receipt of other investigational study agent within previous 30 days or planned during the course of this study. 6. Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the participant participating in the study or making it unlikely the subject could complete the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of related serious adverse events (SAEs) through 365 days after Day 0 immunizationTimepoint: Through 365 days after Day 0 immunization | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of all SAEs through 365 days after Day 0 immunization 2. Adverse events (AEs) through 3 days after last dose of PEP regimenTimepoint: Incidence of all SAEs through 365 days after Day 0 immunization and adverse events (AEs) through 3 days after last dose of PEP regimen | — |
Countries
India
Contacts
Public ContactDr Prasad Kulkarni
Serum Institute of India Pvt. Ltd.
Outcome results
None listed