Safety study of ZuviCellaââ??¢ Vaccine.
- Registration Number
- CTRI/2020/04/024571
- Lead Sponsor
- Zuventus Healthcare Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
1. Children aged 12 months to 12 years of both sexes.
2. Children without history of varicella vaccination and visiting hospitals for immunization program receiving their prescribed ZuviCellaââ??¢ vaccine.
3. Parents/legally acceptable representative of vaccinees agreeing to be interviewed by telephone 7 days after 1st and 2nd vaccination schedules.
4. Parents/ legally acceptable representative of vaccinees willing to fill and sign informed consent form.
1. Immunocompromised patients, AIDS patients, cellular immunodeficiency, hypogammaglobulinemia, dysgammaglobulinemia.
2. Children with acute phase of illnesses characterized by moderate or severe fever. Suspected or confirmed fever in the 3 days prior to vaccination or axillary temperature greater than 99.5�° F on the day of vaccination.
3. Cancer patients undergoing treatment (surgery/chemotherapy), particularly for leukemia, lymphoma or even solid tumors.
4. Children receiving systemic prednisone or equivalent at a dose of > 2mg/kg body weight per day or 20mg/day.
5. Children with documented hypersensitivity to either of the active components or excipients of the vaccine.
6. Any other condition in the opinion of the doctor that justifies exclusion from participation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of suspected adverse eventsTimepoint: 7th day post 1st and 2nd vaccination schedules.
- Secondary Outcome Measures
Name Time Method umber of unsuspected adverse events.Timepoint: 7th day post 1st and 2nd vaccination schedules.