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to assess safety and immunogenicity of measles-rubella (MR) routine immunization in Indonesian Children and Infants
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Safety Study (Measles-Rubella vaccine) | Active Comparator | open labeled, prospective intervention study, only assess the safety outcome. The Measles-Rubella vaccine is administered in infants age 9-12 months or 18 - 47 months. This study group only assessed for safety profile of the Measles-Rubella vaccine. |
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| Sub Study (Measles-Rubella vaccine) | Active Comparator | open labeled, prospective intervention study, assess the safety and immunogenicity outcome. The Measles-Rubella vaccine is administered in infants age 9-12 months or 18 - 47 months. For Sub study, pre- and post immunization sera will be obtained from 200 infants and/or children. Safety assessment also evaluated for 28 days after immunization. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Measles-Rubella (MR) Vaccine | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Immediate systemic events | Number of subjects with at least one serious immediate systemic events within 30 minutes after vaccination | 30 minutes |
| Percentage of immediate systemic events | Percentage of subjects with at least one serious immediate systemic events within 30 minutes after vaccination | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Local reaction | Number of subjects with at least one local reaction occurring within 72 h after vaccination. | 72 hours |
| Systemic reaction | Number of subjects with at least one systemic event occurring within 72 h after vaccination. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dominicus Husada, Dr | Child Health Dept. Dr. Soetomo Hospital/School of Medicine, Airlangga Univ. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Child Health Dept. Dr. Soetomo Hospital, School of Medicine Airlangga Univ. | Surabaya | East Java | 60131 | Indonesia |
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| ID | Term |
|---|---|
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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Safety Group: open labeled, prospective intervention study, only assess the safety outcome Sub Group: open labeled, prospective intervention study, evaluate safety and protectivity outcome
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laboratory analyst are masked for the evaluation of antibody against measles and rubella. The immunogenicity is measured before and after vaccination.
| 72 hours |
| Delayed Local reaction | Number of subjects with at least one local reaction occurring between day 4-14 after vaccination. | 11 days |
| Delayed systemic event | Number of subjects with at least one systemic event occurring between day 4-14 after vaccination. | 11 days |
| Late Local reaction | -Number of subjects with at least one systemic event occurring between day 15 to 28 following vaccination. | 14 days |
| Late Safety (Systemic event) | Number of subjects with at least one systemic event occurring between day 15 to 28 following vaccination. | 14 days |
| Safety (serious adverse event) | - Number of serious adverse event occuring from inclusion until 28 days after immunization | 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. | 28 days |
| Immunogenicity for Measles (Geometric Mean Titer) | - Geometric Mean Titer of measles antibody | 28 days |
| Immunogenicity for Measles (increasing measles antibody titer ≥ 4 times) | - Percentage of infants with increasing measles antibody titer ≥ 4 times | 28 days |
| Immunogenicity for Measles (seroconversion from seronegative to seropositive) | - Percentage of infants with transition of seronegative to seropositive. | 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. | 28 days |
| Immunogenicity for Rubella (Geometric Mean Titer) | - Geometric Mean Titer of Rubella antibody. | 28 days |
| Immunogenicity for Rubella (increasing rubella antibody titer ≥ 4 times) | - Percentage of infants with increasing rubella antibody titer ≥ 4 times | 28 days |
| Immunogenicity for Rubella (seroconversion from seronegative to seropositive) | - Percentage of infants with transition of seronegative to seropositive. | 28 days |