Immunogenicity & Safety of Bio Farma's Measles-Rubella (MR) Vaccine in Indonesian Infants (Bridging Study)
Primary Purpose
Congenital Rubella Infection, Measles
Status
Completed
Phase
Phase 2
Locations
Indonesia
Study Type
Interventional
Intervention
Measles-Rubella vaccine Bio Farma
MR Vaccine SII
Sponsored by
About this trial
This is an interventional prevention trial for Congenital Rubella Infection focused on measuring Vaccine, Measles, Rubella, Bio Farma
Eligibility Criteria
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.
Sites / Locations
- Child Health Dept. Dr. Soetomo Hospital, School of Medicine Airlangga Univ.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
IP batch MRUK-0317
IP Batch MRUK-0417
IP Batch 550118
Control
Arm Description
135 Subjects received Bio Farma's vaccine batch MRUK 0317
135 Subjects received Bio Farma's vaccine batch MRUK 0417
135 Subjects received Bio Farma's vaccine batch MRUK 0417
135 Subjects received SII's MR vaccine batch 012W72230Z
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Immunogenicity of MR Vaccine in infants GMT
• Serological response to MR vaccine in infants: GMT
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.
Immunogenicity of MR Vaccine (seroconversion)
• Serological response to MR vaccine in infants: percentage of infants with transition of seronegative to seropositive.
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.
Comparison between each batch number of Bio Farma's MR vaccine.
• Serological response between each batch number of Bio Farma's MR vaccine.
Safety (immediate reactions)
• Immediate reactions within the first 30 minutes after vaccination
Safety (72 hours)
• Local reactions and systemic events occurring within 72 h after vaccination.
Safety (14 days)
• Local reactions and systemic events occurring within 14 days after vaccination
Safety (15 days to 28 days)
• Local reactions and systemic events occurring between 15 days to 28 days following injection.
Safety (Serious adverse event)
• Any serious adverse event occurring from inclusion until 28 days after immunization
Safety comparison between MR vaccine and control
• Description of adverse events between MR vaccine and control.
Safety comparison between each batch of MR vaccine
• Description of adverse events between each batch number of MR vaccine
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04183114
Brief Title
Immunogenicity & Safety of Bio Farma's Measles-Rubella (MR) Vaccine in Indonesian Infants (Bridging Study)
Official Title
Immunogenicity & Safety of Bio Farma's Measles-Rubella (MR) Vaccine in Indonesian Infants (Bridging Study)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
September 3, 2019 (Actual)
Primary Completion Date
November 11, 2019 (Actual)
Study Completion Date
November 11, 2019 (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
Yes
5. Study Description
Brief Summary
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
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Rubella Infection, Measles
Keywords
Vaccine, Measles, Rubella, Bio Farma
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
healthy infants aged 9 - 12 months
Masking
Care ProviderInvestigatorOutcomes Assessor
Masking Description
The masking uses observer blind with some unmasked staff to prepare the vaccine to be administered by masked investigator.
Allocation
Randomized
Enrollment
540 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IP batch MRUK-0317
Arm Type
Experimental
Arm Description
135 Subjects received Bio Farma's vaccine batch MRUK 0317
Arm Title
IP Batch MRUK-0417
Arm Type
Experimental
Arm Description
135 Subjects received Bio Farma's vaccine batch MRUK 0417
Arm Title
IP Batch 550118
Arm Type
Experimental
Arm Description
135 Subjects received Bio Farma's vaccine batch MRUK 0417
Arm Title
Control
Arm Type
Active Comparator
Arm Description
135 Subjects received SII's MR vaccine batch 012W72230Z
Intervention Type
Biological
Intervention Name(s)
Measles-Rubella vaccine Bio Farma
Other Intervention Name(s)
Vaksin Campak Rubella Bio Farma
Intervention Description
MR vaccine produced by Bio Frama with 3 consecutive batches
Intervention Type
Biological
Intervention Name(s)
MR Vaccine SII
Intervention Description
MR Vaccine produced by SII (Already registered in Indonesia)
Primary Outcome Measure Information:
Title
Protectivity of Measles
Description
Percentage of subjects with anti measles titer ≥ 8(1/dil), 28 days after one dose of Bio Farma's MR vaccine in Infants
Time Frame
4 months
Title
Protectivity of Rubella
Description
Percentage of subjects with anti rubella titer ≥11 IU/ml, 28 days after one dose of Bio Farma's MR vaccine in Infants
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Immunogenicity of MR Vaccine in infants GMT
Description
• Serological response to MR vaccine in infants: GMT
Time Frame
up to 4 months
Title
Immunogenicity of MR Vaccine (4 Folds increase of antibody titer)
Description
• Serological response to MR vaccine in infants: percentage of infants with increasing antibody titer > 4 times.
Time Frame
up to 4 months
Title
Immunogenicity of MR Vaccine (seroconversion)
Description
• Serological response to MR vaccine in infants: percentage of infants with transition of seronegative to seropositive.
Time Frame
up to 4 months
Title
Comparison Between MR (Bio Farma) Vaccine and Registered MR Vaccine
Description
• 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.
Time Frame
up to 4 months
Title
Comparison between each batch number of Bio Farma's MR vaccine.
Description
• Serological response between each batch number of Bio Farma's MR vaccine.
Time Frame
up to 4 months
Title
Safety (immediate reactions)
Description
• Immediate reactions within the first 30 minutes after vaccination
Time Frame
up to 30 minutes after vaccination
Title
Safety (72 hours)
Description
• Local reactions and systemic events occurring within 72 h after vaccination.
Time Frame
up to 72 hours after vaccination
Title
Safety (14 days)
Description
• Local reactions and systemic events occurring within 14 days after vaccination
Time Frame
up to 14 days after vaccination
Title
Safety (15 days to 28 days)
Description
• Local reactions and systemic events occurring between 15 days to 28 days following injection.
Time Frame
up to 14 days
Title
Safety (Serious adverse event)
Description
• Any serious adverse event occurring from inclusion until 28 days after immunization
Time Frame
up to 1 months/28 days
Title
Safety comparison between MR vaccine and control
Description
• Description of adverse events between MR vaccine and control.
Time Frame
up to 1 months/28 days
Title
Safety comparison between each batch of MR vaccine
Description
• Description of adverse events between each batch number of MR vaccine
Time Frame
up to 1 months/28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Months
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
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
IPD Sharing Plan Description
no plan for IPD. Data are restricted to be used by investigators and sponsor only.
Learn more about this trial
Immunogenicity & Safety of Bio Farma's Measles-Rubella (MR) Vaccine in Indonesian Infants (Bridging Study)
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