None listed
Conditions
Interventions
Intervention1: Varicella-Zoster Virus, Live Attenuated (Oka Strain) ââ?°Â¥ 2000 PFU (ZuviCellaââ??¢ vaccine): 2 doses of vaccine to be administered subcutaneously at least 3 months apart.
The upper
Sponsors
Zuventus Healthcare Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of suspected adverse eventsTimepoint: 7th day post 1st and 2nd vaccination schedules. | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of unsuspected adverse events.Timepoint: 7th day post 1st and 2nd vaccination schedules. | — |
Countries
India
Contacts
Public ContactDr Bhupesh Dewan
Zuventus Healthcare Limited
Outcome results
None listed