Health Condition 1: Z23- Encounter for immunization
Conditions
Interventions
Intervention1: Measles & Rubella vaccine (Live) I.P.
(Freeze Dried) â?? Single Dose of M/s Cadila
Healthcare Limited: Each subject will be given a single dose of 0.5ml vaccine given as a subcutaneous
Sponsors
Cadila Healthcare Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects who are sero-positive for measles and rubellaTimepoint: 6 weeks following vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Geometric mean titre of anti-measles and anti-rubella antibodiesTimepoint: 6 weeks following vaccination;Local and systemic adverse eventsTimepoint: 6 weeks and 6 months following vaccination;Overall tolerability evaluationTimepoint: 6 weeks and 6 months following vaccination;Serious adverse events reportedTimepoint: 6 weeks and 6 months following vaccination;Seroconversion rate for measles and rubella in subjects who were seronegative before randomizationTimepoint: 6 weeks following vaccination | — |
Countries
India
Contacts
Public ContactDr Jayesh Sanmukhani
Cadila Healthcare Ltd
Outcome results
None listed