Study to check safety of Rabishield and Rabivax-S vaccines in patients with animal bites by suspected rabid animals
- Conditions
- Health Condition 1: A829- Rabies, unspecified
- Registration Number
- CTRI/2019/06/019622
- Lead Sponsor
- Serum Institute of India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1. Patients aged more than 2 years of either sex
2. WHO Category III exposure(s) by a suspected rabid animal < 72 hours prior to enrollment and < 24 hours if exposure to face, neck, hand or fingers.
3. Written informed consent by subjects (>=18 years) / parents of subjects (2-17 years).
4. Written informed assent by subjects aged 7-17 years
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of related serious adverse events (SAEs) through 365 days after Day 0 immunizationTimepoint: Through 365 days after Day 0 immunization
- Secondary Outcome Measures
Name Time Method 1. Incidence of all SAEs through 365 days after Day 0 immunization <br/ ><br> <br/ ><br>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