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

Tahapan Penelitian : Initial
Sponsor:
Mitra Pelaksana:
RSUD DR Soetomo, Surabaya
No Registry
INA-0BD1YLW
Tanggal Input Registry : 29-08-2019

03-09-2019
• Percentage of subjects with anti measles titer  8(1/dil) and anti rubella titer ≥11 IU/ml, 28 days after one dose of Bio Farma’s MR vaccine in Infants
Immunogenicity • Serological response to MR vaccine in infants: GMT, percentage of infants with increasing antibody titer  4 times and/or percentage of infants with transition of seronegative to seropositive. • Serological response to Measles and Rubella component, pre and post vaccination with Bio Farma's MR vaccine compare to registered MR vaccine in infants. • Serological response between each batch number of Bio Farma/s MR vaccine. Safety • Immediate reactions within the first 30 minutes after vaccination • Local reactions and systemic events occurring within 72 h after vaccination. • Local reactions and systemic events occurring within 14 days after vaccination • Local reactions and systemic events occurring between 15 days to 28 days following injection. • Any serious adverse event occurring from inclusion until 28 days after immunization • Description of adverse events between MR vaccine and control. • Description of adverse events between each batch number of MR vaccine
 
Immunogenicity & Safety of Bio Farma’s Measles-Rubella (MR) Vaccine in Indonesian Infants
Immunogenicity & Safety of Bio Farma’s Measles-Rubella (MR) Vaccine in Indonesian Infants
Bioequivalence study
IP: Vaksin Measle - Rubella (MR) Biofarma Active Comparator: Vaksin Measle Rubella (MR) SII
540
 

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C). 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.
 
1030/UN6.KEP/EC/2019
MR BF 0318
Dr. Dominicus Husada