Clinical study to compare the immune response and safety of vaccine for prevention of Measles and Rubella diseases (MR vaccine) manufactured by Cadila Healthcare Ltd. with MR vaccine manufactured by Serum Institute of India Ltd. in children 9-12 months of age
- Conditions
- Health Condition 1: Z23- Encounter for immunization
- Registration Number
- CTRI/2017/05/008701
- Lead Sponsor
- Cadila Healthcare Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1. Healthy paediatric subjects of either sex aged 9 months to 12 months
2. Informed consent of either parent (mother or father) and their willingness to
be followed up for at least 6 months after vaccination of their child
3. Parents with adequate literacy to fill the diary cards
1. Subjects with a history of anaphylaxis or serious reactions to other vaccines, gelatin and / or albumin
2. Subjects with a history of previous measles / rubella infection or vaccination with measles / rubella containing vaccine or if they had been exposed# to measles or rubella virus within 30 days of trial commencement
3. Subjects with a history of convulsions, epilepsy, other central nervous system
diseases, severe disease of haematopoietic system, decompensated heart disease or impaired renal function
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
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 3 months
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