Back to resultsReactogenicity and Protectivity Following Measles- Rubella (MR) Routine Immunization in Indonesian Infants and Children
Primary Purpose
Safety Issues, Immunogenicity
Status
Completed
Phase
Phase 4
Locations
Indonesia
Study Type
Interventional
Intervention
Measles-Rubella (MR) Vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Safety Issues focused on measuring Measles-Rubella, Vaccine, Safety, Immunogenicity, Reactogenicity, Protectivity
Eligibility Criteria
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)
Sites / Locations
- Child Health Dept. Dr. Soetomo Hospital, School of Medicine Airlangga Univ.
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Safety Study (Measles-Rubella vaccine)
Sub Study (Measles-Rubella vaccine)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Number of Immediate systemic events
Number of subjects with at least one serious immediate systemic events within 30 minutes after vaccination
Percentage of immediate systemic events
Percentage of subjects with at least one serious immediate systemic events within 30 minutes after vaccination
Secondary Outcome Measures
Local reaction
Number of subjects with at least one local reaction occurring within 72 h after vaccination.
Systemic reaction
Number of subjects with at least one systemic event occurring within 72 h after vaccination.
Delayed Local reaction
Number of subjects with at least one local reaction occurring between day 4-14 after vaccination.
Delayed systemic event
Number of subjects with at least one systemic event occurring between day 4-14 after vaccination.
Late Local reaction
-Number of subjects with at least one systemic event occurring between day 15 to 28 following vaccination.
Late Safety (Systemic event)
Number of subjects with at least one systemic event occurring between day 15 to 28 following vaccination.
Safety (serious adverse event)
- Number of serious adverse event occuring from inclusion until 28 days after immunization
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.
Immunogenicity for Measles (Geometric Mean Titer)
- Geometric Mean Titer of measles antibody
Immunogenicity for Measles (increasing measles antibody titer ≥ 4 times)
- Percentage of infants with increasing measles antibody titer ≥ 4 times
Immunogenicity for Measles (seroconversion from seronegative to seropositive)
- Percentage of infants with transition of seronegative to seropositive.
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.
Immunogenicity for Rubella (Geometric Mean Titer)
- Geometric Mean Titer of Rubella antibody.
Immunogenicity for Rubella (increasing rubella antibody titer ≥ 4 times)
- Percentage of infants with increasing rubella antibody titer ≥ 4 times
Immunogenicity for Rubella (seroconversion from seronegative to seropositive)
- Percentage of infants with transition of seronegative to seropositive.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03680417
Brief Title
Reactogenicity and Protectivity Following Measles- Rubella (MR) Routine Immunization in Indonesian Infants and Children
Official Title
Reactogenicity and Protectivity Following Measles- Rubella (MR) Routine Immunization in Indonesian Infants and Children
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
November 16, 2017 (Actual)
Primary Completion Date
February 26, 2018 (Actual)
Study Completion Date
August 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PT Bio Farma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Safety Issues, Immunogenicity
Keywords
Measles-Rubella, Vaccine, Safety, Immunogenicity, Reactogenicity, Protectivity
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
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.
Allocation
Randomized
Enrollment
590 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Safety Study (Measles-Rubella vaccine)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sub Study (Measles-Rubella vaccine)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Measles-Rubella (MR) Vaccine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Immediate systemic events
Description
Number of subjects with at least one serious immediate systemic events within 30 minutes after vaccination
Time Frame
30 minutes
Title
Percentage of immediate systemic events
Description
Percentage of subjects with at least one serious immediate systemic events within 30 minutes after vaccination
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Local reaction
Description
Number of subjects with at least one local reaction occurring within 72 h after vaccination.
Time Frame
72 hours
Title
Systemic reaction
Description
Number of subjects with at least one systemic event occurring within 72 h after vaccination.
Time Frame
72 hours
Title
Delayed Local reaction
Description
Number of subjects with at least one local reaction occurring between day 4-14 after vaccination.
Time Frame
11 days
Title
Delayed systemic event
Description
Number of subjects with at least one systemic event occurring between day 4-14 after vaccination.
Time Frame
11 days
Title
Late Local reaction
Description
-Number of subjects with at least one systemic event occurring between day 15 to 28 following vaccination.
Time Frame
14 days
Title
Late Safety (Systemic event)
Description
Number of subjects with at least one systemic event occurring between day 15 to 28 following vaccination.
Time Frame
14 days
Title
Safety (serious adverse event)
Description
- Number of serious adverse event occuring from inclusion until 28 days after immunization
Time Frame
28 days
Title
Immunogenicity for Measles (subject with anti measles titer ≥ 8 (1/dil))
Description
- Percentage of subjects with anti measles titer ≥ 8 (1/dil), 28 days after one dose of MR vaccine in Infants & Children.
Time Frame
28 days
Title
Immunogenicity for Measles (Geometric Mean Titer)
Description
- Geometric Mean Titer of measles antibody
Time Frame
28 days
Title
Immunogenicity for Measles (increasing measles antibody titer ≥ 4 times)
Description
- Percentage of infants with increasing measles antibody titer ≥ 4 times
Time Frame
28 days
Title
Immunogenicity for Measles (seroconversion from seronegative to seropositive)
Description
- Percentage of infants with transition of seronegative to seropositive.
Time Frame
28 days
Title
Immunogenicity for Rubella (Subjects with anti rubella titer ≥11 IU/ml)
Description
- Percentage of subjects with anti rubella titer ≥11 IU/ml, 28 days after one dose of MR vaccine in Infants & Children.
Time Frame
28 days
Title
Immunogenicity for Rubella (Geometric Mean Titer)
Description
- Geometric Mean Titer of Rubella antibody.
Time Frame
28 days
Title
Immunogenicity for Rubella (increasing rubella antibody titer ≥ 4 times)
Description
- Percentage of infants with increasing rubella antibody titer ≥ 4 times
Time Frame
28 days
Title
Immunogenicity for Rubella (seroconversion from seronegative to seropositive)
Description
- Percentage of infants with transition of seronegative to seropositive.
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Months
Maximum Age & Unit of Time
47 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominicus Husada, Dr
Organizational Affiliation
Child Health Dept. Dr. Soetomo Hospital/School of Medicine, Airlangga Univ.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Child Health Dept. Dr. Soetomo Hospital, School of Medicine Airlangga Univ.
City
Surabaya
State/Province
East Java
ZIP/Postal Code
60131
Country
Indonesia
12. IPD Sharing Statement
Plan to Share IPD
No
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Reactogenicity and Protectivity Following Measles- Rubella (MR) Routine Immunization in Indonesian Infants and Children
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