Reactogenicity and Protectivity Following Measles- Rubella (MR) Routine Immunization in Indonesian Infants and Children

Study Overview
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Brief Summary
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to assess safety and immunogenicity of measles-rubella (MR) routine immunization in Indonesian Children and Infants

Detailed Description
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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

Official Title
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Reactogenicity and Protectivity Following Measles- Rubella (MR) Routine Immunization in Indonesian Infants and Children

Conditions
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Safety Issues, Immunogenicity

Intervention / Treatment
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* Biological: Measles-Rubella (MR) Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy infants (9-12 months) or children (18-47 months) Will receive MR routine immunization. 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: MR vaccine given simultaneously with other vaccination, except Pentabio (DTP/HB/Hib)

Ages Eligible for Study
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Minimum Age: 9 Months
Maximum Age: 47 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: Safety Group: open labeled, prospective intervention study, only assess the safety outcome Sub Group: open labeled, prospective intervention study, evaluate safety and protectivity outcome
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Safety Study (Measles-Rubella vaccine)<br>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. | Biological: Measles-Rubella (MR) Vaccine<br>* 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.<br>|
| Active Comparator: Sub Study (Measles-Rubella vaccine)<br>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. | Biological: Measles-Rubella (MR) Vaccine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Measles-Rubella, Vaccine, Safety, Immunogenicity, Reactogenicity, Protectivity