Clinical study to compare the immune response and safety of Measles, Mumps and Rubella (MMR) vaccine manufactured by Cadila Healthcare Ltd. with MMR vaccine manufactured by Serum Institute of India Ltd. in children 15-18 months of age
- Conditions
- Health Condition 1: Z23- Encounter for immunization
- Registration Number
- CTRI/2015/05/005784
- Lead Sponsor
- Cadila Healthcare Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 327
1. Healthy paediatric subjects of either sex aged 15 months to 18 months
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 measles, mumps or rubella infection or MMR vaccination, or if they had been exposed to any of these three diseases within 30 days of trial commencement
3. Subjects having received measles vaccine less than 3 months back
4. Subjects with a history of convulsions, epilepsy, other central nervous system diseases, severe disease of haematopoietic system, decompensated heart disease or impaired renal function
5. Subjects with an acute febrile illness at the time of randomization
6. Any other parenteral vaccine administration within 30 days of initiation of the study or during the study
7. A history of serious chronic illness, major congenital defects, immunosuppression (immunosuppressive illness or therapy)
8. Subjects who have received blood, blood products or immunoglobulins during the preceding 3 months
9. 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 Proportion of subjects who are sero-positive for measles, mumps and rubella at the end of study in the two groupsTimepoint: 42 days following vaccination
- Secondary Outcome Measures
Name Time Method Geometric mean titre of anti-measles, anti-mumps and anti-rubella antibodies in the two groups at the end of the studyTimepoint: 42 days following vaccination;Sero-conversion rate at the end of the study for measles, mumps and rubella who were sero-negative before randomization in the two groupsTimepoint: 42 days following vaccination