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

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

Exclusion criteria

• Subject concomitantly enrolled or scheduled to be enrolled in another trial.
• Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature > 37.5 Centigrade).
• Known history of allergy to neomycin, kanamycin or erythromycin or any component of the vaccines.
• History of immunodeficiency disorder or disorders like HIV infection, leukemia, lymphoma, or generalized malignancy that can alter immune response.
• Subjects who have previously received any measles and/or rubella containing vaccines.
• Subjects who had a clinical history of measles/rubella infection.
• 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).
• Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.
• Subject already immunized with any vaccine within 4 weeks prior vaccination.