Immunogenicity, Safety Issues
Conditions
Keywords
Measles-Rubella, Vaccine, Safety, Immunogenicity, Reactogenicity, Protectivity
Brief summary
to assess safety and immunogenicity of measles-rubella (MR) routine immunization in Indonesian Children and Infants
Detailed description
* 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
Interventions
BIOLOGICALMeasles-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.
Sponsors
PT Bio Farma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
laboratory analyst are masked for the evaluation of antibody against measles and rubella. The immunogenicity is measured before and after vaccination.
Intervention 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
Eligibility
Sex/Gender
ALL
Age
9 Months to 47 Months
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Local reaction | 72 hours | Number of subjects with at least one local reaction occurring within 72 h after vaccination. |
| 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. |
| Immunogenicity for Measles (Geometric Mean Titer) | 28 days | \- Geometric Mean Titer of measles antibody |
| Systemic reaction | 72 hours | Number of subjects with at least one systemic event occurring within 72 h after vaccination. |
Countries
Indonesia
Outcome results
None listed