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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 .

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

Conditions
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Congenital Rubella Infection, Measles

Intervention / Treatment
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* Biological: Measles-Rubella vaccine Bio Farma
* Biological: MR Vaccine SII


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 9 Months
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: healthy infants aged 9 - 12 months
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IP batch MRUK-0317<br>135 Subjects received Bio Farma's vaccine batch MRUK 0317 | Biological: Measles-Rubella vaccine Bio Farma<br>* MR vaccine produced by Bio Frama with 3 consecutive batches<br>* Other names: Vaksin Campak Rubella Bio Farma;|
| Experimental: IP Batch MRUK-0417<br>135 Subjects received Bio Farma's vaccine batch MRUK 0417 | Biological: Measles-Rubella vaccine Bio Farma<br>* MR vaccine produced by Bio Frama with 3 consecutive batches<br>* Other names: Vaksin Campak Rubella Bio Farma;|
| Experimental: IP Batch 550118<br>135 Subjects received Bio Farma's vaccine batch MRUK 0417 | Biological: Measles-Rubella vaccine Bio Farma<br>* MR vaccine produced by Bio Frama with 3 consecutive batches<br>* Other names: Vaksin Campak Rubella Bio Farma;|
| Active Comparator: Control<br>135 Subjects received SII's MR vaccine batch 012W72230Z | Biological: MR Vaccine SII<br>* MR Vaccine produced by SII (Already registered in Indonesia)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaccine, Measles, Rubella, Bio Farma