Immunogenicity & Safety of Bio Farma's Measles-Rubella (MR) Vaccine in Indonesian Infants (Bridging Study)

Immunogenicity & Safety of Bio Farma's Measles-Rubella (MR) Vaccine in Indonesian Infants (Bridging Study)

Thus study is a clinical trial for Measles and Rubella vaccine that will be used inIndonesian National Program of Immunization. The study design will be randomized, observer blind, prospective intervention study.

The objectives of the study are:

• To assess the protectivity rate of Bio Farma's Measles/Rubella (MR) vaccine in infants
• To describe antibody response to Measles and Rubella after 1 dose of Bio Farma's MR vaccine as a primary dose in infants
• To assess the safety of Bio Farma's Measles/Rubella (MR) vaccine in infants
• To evaluate immunogenicity and safety one dose of Bio Farma's MR vaccine compare to registered MR vaccine.
• To evaluate immunogenicity and safety in three consecutive batches of Bio Farma's MR vaccine in infants .

Inclusion Criteria:

1. Healthy Infants, 9-12 months
2. Parents have been informed properly regarding the study and signed the informed consent form
3. Parents will commit themselves to comply with the instructions of the investigator and the schedule of the trial.

Exclusion Criteria:

1. Subject concomitantly enrolled or scheduled to be enrolled in another trial.
2. Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature > 37.5 Centigrade).
3. Known history of allergy to neomycin, kanamycin or erythromycin or any component of the vaccines.
4. History of immunodeficiency disorder or disorders like HIV infection, leukemia, lymphoma, or generalized malignancy that can alter immune response.
5. Subjects who have previously received any measles and/or rubella containing vaccines.
6. Subjects who had a clinical history of measles/rubella infection.
7. Subjects who has received in the previous 3 months a treatment likely to alter the immune response (intravenous immunoglobulin, blood-derived products or long term corticosteroidtherapy (> 2 weeks).
8. Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.
9. Subject already immunized with any vaccine within 4 weeks prior vaccination.