Health Condition 1: Z23- Encounter for immunization
Conditions
Interventions
Intervention1: Single-dose vials of MMR vaccine (Live) (Freeze-dried) of M/s Cadila Healthcare Limited: Each subject will be given a single dose of 0.5ml vaccine from single dose vial given as a subcu
Sponsors
Cadila Healthcare Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactDr Jayesh Sanmukhani
Cadila Healthcare Ltd
Outcome results
None listed