Reactogenicity and Protectivity Following Measles- Rubella (MR) Routine Immunization in Indonesian Infants and Children
Study Details
Study Description
Brief Summary
to assess safety and immunogenicity of measles-rubella (MR) routine immunization in Indonesian Children and Infants
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
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to asses serious immediate systemic events,
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to assess local and systemic reaction after Measles-Rubella (MR) vaccine in infants and children,
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to evaluate protectivity and antibody response to measles and rubella after 1 dose of MR vaccine
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Safety Study (Measles-Rubella vaccine) 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
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.
|
| Active Comparator: Sub Study (Measles-Rubella vaccine) 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
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.
|
Outcome Measures
Primary Outcome Measures
- Number of Immediate systemic events [30 minutes]
Number of subjects with at least one serious immediate systemic events within 30 minutes after vaccination
- Percentage of immediate systemic events [30 minutes]
Percentage of subjects with at least one serious immediate systemic events within 30 minutes after vaccination
Secondary Outcome Measures
- Local reaction [72 hours]
Number of subjects with at least one local reaction occurring within 72 h after vaccination.
- Systemic reaction [72 hours]
Number of subjects with at least one systemic event occurring within 72 h after vaccination.
- Delayed Local reaction [11 days]
Number of subjects with at least one local reaction occurring between day 4-14 after vaccination.
- Delayed systemic event [11 days]
Number of subjects with at least one systemic event occurring between day 4-14 after vaccination.
- Late Local reaction [14 days]
-Number of subjects with at least one systemic event occurring between day 15 to 28 following vaccination.
- Late Safety (Systemic event) [14 days]
Number of subjects with at least one systemic event occurring between day 15 to 28 following vaccination.
- Safety (serious adverse event) [28 days]
- Number of serious adverse event occuring from inclusion until 28 days after immunization
- Immunogenicity for Measles (subject with anti measles titer ≥ 8 (1/dil)) [28 days]
- Percentage of subjects with anti measles titer ≥ 8 (1/dil), 28 days after one dose of MR vaccine in Infants & Children.
- Immunogenicity for Measles (Geometric Mean Titer) [28 days]
- Geometric Mean Titer of measles antibody
- Immunogenicity for Measles (increasing measles antibody titer ≥ 4 times) [28 days]
- Percentage of infants with increasing measles antibody titer ≥ 4 times
- Immunogenicity for Measles (seroconversion from seronegative to seropositive) [28 days]
- Percentage of infants with transition of seronegative to seropositive.
- Immunogenicity for Rubella (Subjects with anti rubella titer ≥11 IU/ml) [28 days]
- Percentage of subjects with anti rubella titer ≥11 IU/ml, 28 days after one dose of MR vaccine in Infants & Children.
- Immunogenicity for Rubella (Geometric Mean Titer) [28 days]
- Geometric Mean Titer of Rubella antibody.
- Immunogenicity for Rubella (increasing rubella antibody titer ≥ 4 times) [28 days]
- Percentage of infants with increasing rubella antibody titer ≥ 4 times
- Immunogenicity for Rubella (seroconversion from seronegative to seropositive) [28 days]
- Percentage of infants with transition of seronegative to seropositive.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy infants (9-12 months) or children (18-47 months)
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Will receive MR routine immunization.
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Parents have been informed properly regarding the study and signed the informed consent form.
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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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Child Health Dept. Dr. Soetomo Hospital, School of Medicine Airlangga Univ. | Surabaya | East Java | Indonesia | 60131 |
Sponsors and Collaborators
- PT Bio Farma
Investigators
- Principal Investigator: Dominicus Husada, Dr, Child Health Dept. Dr. Soetomo Hospital/School of Medicine, Airlangga Univ.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PMS-MR-0417