to assess safety and immunogenicity of measles-rubella (MR) routine immunization in Indonesian Children and Infants
* to asses serious immediate systemic events, * to assess local and systemic reaction after Measles-Rubella (MR) vaccine in infants and children, * to evaluate protectivity and antibody response to measles and rubella after 1 dose of MR vaccine
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
590
Measles and Rubella Vaccine, live attenuated (Serum Institute of India) Form : Freeze dried Dose : 1 dose 0.5 ml contains not less than 1000 CCID50 of measles virus and 1000 CCID50 of rubella virus.
Child Health Dept. Dr. Soetomo Hospital, School of Medicine Airlangga Univ.
Surabaya, East Java, Indonesia
Number of Immediate systemic events
Number of subjects with at least one serious immediate systemic events within 30 minutes after vaccination
Time frame: 30 minutes
Percentage of immediate systemic events
Percentage of subjects with at least one serious immediate systemic events within 30 minutes after vaccination
Time frame: 30 minutes
Local reaction
Number of subjects with at least one local reaction occurring within 72 h after vaccination.
Time frame: 72 hours
Systemic reaction
Number of subjects with at least one systemic event occurring within 72 h after vaccination.
Time frame: 72 hours
Delayed Local reaction
Number of subjects with at least one local reaction occurring between day 4-14 after vaccination.
Time frame: 11 days
Delayed systemic event
Number of subjects with at least one systemic event occurring between day 4-14 after vaccination.
Time frame: 11 days
Late Local reaction
-Number of subjects with at least one systemic event occurring between day 15 to 28 following vaccination.
Time frame: 14 days
Late Safety (Systemic event)
Number of subjects with at least one systemic event occurring between day 15 to 28 following vaccination.
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Time frame: 14 days
Safety (serious adverse event)
\- Number of serious adverse event occuring from inclusion until 28 days after immunization
Time frame: 28 days
Immunogenicity for Measles (subject with anti measles titer ≥ 8 (1/dil))
\- Percentage of subjects with anti measles titer ≥ 8 (1/dil), 28 days after one dose of MR vaccine in Infants \& Children.
Time frame: 28 days
Immunogenicity for Measles (Geometric Mean Titer)
\- Geometric Mean Titer of measles antibody
Time frame: 28 days
Immunogenicity for Measles (increasing measles antibody titer ≥ 4 times)
\- Percentage of infants with increasing measles antibody titer ≥ 4 times
Time frame: 28 days
Immunogenicity for Measles (seroconversion from seronegative to seropositive)
\- Percentage of infants with transition of seronegative to seropositive.
Time frame: 28 days
Immunogenicity for Rubella (Subjects with anti rubella titer ≥11 IU/ml)
\- Percentage of subjects with anti rubella titer ≥11 IU/ml, 28 days after one dose of MR vaccine in Infants \& Children.
Time frame: 28 days
Immunogenicity for Rubella (Geometric Mean Titer)
\- Geometric Mean Titer of Rubella antibody.
Time frame: 28 days
Immunogenicity for Rubella (increasing rubella antibody titer ≥ 4 times)
\- Percentage of infants with increasing rubella antibody titer ≥ 4 times
Time frame: 28 days
Immunogenicity for Rubella (seroconversion from seronegative to seropositive)
\- Percentage of infants with transition of seronegative to seropositive.
Time frame: 28 days