Clinical study to compare the immune response and safety of Chicken Pox vaccine manufactured byCadila Healthcare Ltd. with another Chicken Pox vaccine marketed in India inchildren 1-12 years of age
- Conditions
- Health Condition 1: Z23- Encounter for immunization
- Registration Number
- CTRI/2015/07/006059
- Lead Sponsor
- Cadila Healthcare Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 256
1. Healthy paediatric subjects of either sex aged 1 year to 12 years
2. Informed consent of the parents/guardians and their willingness to be followed up for at least 6 weeks after vaccination of their child
3. Parents/guardians with adequate literacy to fill the diary cards
1. Subjects with a history of anaphylaxis or serious reactions to other vaccines, neomycin, gelatin and / or albumin
2. Subjects with a history of previous varicella infection or vaccination, or if they had been exposed to the disease within 30 days of trial commencement
3. Subjects with a history of convulsions, seizures, other central nervous system diseases, severe disease of haematopoietic system, cardiovascular system, liver or kidney
4. Subjects with an acute febrile illness at the time of randomization
5. Any other vaccine administration within 30 days of initiation of the study or planned during the study period
6. A history of serious chronic illness, major congenital defects, immunosuppression (immunosuppressive illness or therapy)
7. Subjects who have received blood, blood products or immunoglobulins during the preceding 6 months or have planned during the study period
8. Subjects with any other clinically significant concurrent illness affecting immune response after vaccination
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method