Randomized double blind clinical trial (phase 2) RAZI- MMR vaccines in comparison with a standard vaccine in 12 – 24 months old children.

This study is a double blind, randomized, controlled phase II clinical trial. The aims of this study are assessment of immunogenicity and safety of the measles, mumps, and rubella vaccine with new mumps component (RS12). Inclusion criteria include: no previous history of immunization against measles, mumps and rubella; no known exposure to measles, mumps and rubella in the preceding 4 weeks; not being treated for any condition that impairs the immune response and exclusion criteria include: fever of >38◦c at the time of assessment other signs of acute infection, administration of immunoglobulin or blood transfusion within the previous 3 months and a history of allergy to any vaccine components. 420 Healthy children 12 to 24 months of age will be divided in two groups after meeting inclusion criteria and obtaining written informed consent from their parents. Children will be randomly assigned (1:1) to receive 2 dose of either MMR (RS12)or MMR used in routine vaccination , administered 0/5 cc subcutaneously, one dose will be injected in 12 months of age and second dose will be injected in18 months of age. Blood samples will be obtained from each subject for immunogenicity analysis immediately before vaccination and 6-8 weeks after first vaccination and 6 weeks after second vaccination. For early adverse event, children will be observed during half hour( 30 minutes) after each vaccination by physician and late adverse event will be recorded within the 6-8 weeks after each vaccination.

Razi Vaccine and Serum Research Institute