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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IP batch MRUK-0317 | Experimental | 135 Subjects received Bio Farma's vaccine batch MRUK 0317 |
|
| IP Batch MRUK-0417 | Experimental | 135 Subjects received Bio Farma's vaccine batch MRUK 0417 |
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| IP Batch 550118 | Experimental | 135 Subjects received Bio Farma's vaccine batch MRUK 0417 |
|
| Control | Active Comparator | 135 Subjects received SII's MR vaccine batch 012W72230Z |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Measles-Rubella vaccine Bio Farma | Biological | MR vaccine produced by Bio Frama with 3 consecutive batches |
|
| Measure | Description | Time Frame |
|---|---|---|
| Protectivity of Measles | Percentage of subjects with anti measles titer ≥ 8(1/dil), 28 days after one dose of Bio Farma's MR vaccine in Infants | 4 months |
| Protectivity of Rubella | Percentage of subjects with anti rubella titer ≥11 IU/ml, 28 days after one dose of Bio Farma's MR vaccine in Infants | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity of MR Vaccine in infants GMT | • Serological response to MR vaccine in infants: GMT | up to 4 months |
| Immunogenicity of MR Vaccine (4 Folds increase of antibody titer) | • Serological response to MR vaccine in infants: percentage of infants with increasing antibody titer > 4 times. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Child Health Dept. Dr. Soetomo Hospital, School of Medicine Airlangga Univ. | Surabaya | East Java | 60131 | Indonesia |
no plan for IPD. Data are restricted to be used by investigators and sponsor only.
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| ID | Term |
|---|---|
| D008457 | Measles |
| D012409 | Rubella |
| ID | Term |
|---|---|
| D018185 | Morbillivirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
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healthy infants aged 9 - 12 months
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The masking uses observer blind with some unmasked staff to prepare the vaccine to be administered by masked investigator.
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| MR Vaccine SII | Biological | MR Vaccine produced by SII (Already registered in Indonesia) |
|
| up to 4 months |
| Immunogenicity of MR Vaccine (seroconversion) | • Serological response to MR vaccine in infants: percentage of infants with transition of seronegative to seropositive. | up to 4 months |
| Comparison Between MR (Bio Farma) Vaccine and Registered MR Vaccine | • Comparability of serological response to Measles and Rubella component, pre and post vaccination with Bio Farma's MR vaccine compared to registered MR vaccine in infants. | up to 4 months |
| Comparison between each batch number of Bio Farma's MR vaccine. | • Serological response between each batch number of Bio Farma's MR vaccine. | up to 4 months |
| Safety (immediate reactions) | • Immediate reactions within the first 30 minutes after vaccination | up to 30 minutes after vaccination |
| Safety (72 hours) | • Local reactions and systemic events occurring within 72 h after vaccination. | up to 72 hours after vaccination |
| Safety (14 days) | • Local reactions and systemic events occurring within 14 days after vaccination | up to 14 days after vaccination |
| Safety (15 days to 28 days) | • Local reactions and systemic events occurring between 15 days to 28 days following injection. | up to 14 days |
| Safety (Serious adverse event) | • Any serious adverse event occurring from inclusion until 28 days after immunization | up to 1 months/28 days |
| Safety comparison between MR vaccine and control | • Description of adverse events between MR vaccine and control. | up to 1 months/28 days |
| Safety comparison between each batch of MR vaccine | • Description of adverse events between each batch number of MR vaccine | up to 1 months/28 days |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D018355 | Rubivirus Infections |
| D014036 | Togaviridae Infections |