A Phase 2/3 interventional study of Measles-Rubella vaccine Bio Farma and MR Vaccine SII in Congenital Rubella Infection and Measles, sponsored by PT Bio Farma. Completed at 1 site in Indonesia. Open to participants aged 9 Months to 12 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-04.
Sponsored by PT Bio Farma · Phase 2/3, Interventional, and Prevention
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.
The objectives of the study are:
134 studies on the registry are indexed under Measles; 17 are open to participants now.
This study's enrollment of 540 is below the median of 852 across 105 interventional studies indexed under Measles.
Browse Measles studies →PT Bio Farma is the lead sponsor of 47 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
135 Subjects received Bio Farma's vaccine batch MRUK 0317
Biological: Measles-Rubella vaccine Bio Farma
135 Subjects received Bio Farma's vaccine batch MRUK 0417
Biological: Measles-Rubella vaccine Bio Farma
135 Subjects received Bio Farma's vaccine batch MRUK 0417
Biological: Measles-Rubella vaccine Bio Farma
135 Subjects received SII's MR vaccine batch 012W72230Z
Biological: MR Vaccine SII
MR vaccine produced by Bio Frama with 3 consecutive batches
Also known as: Vaksin Campak Rubella Bio Farma
MR Vaccine produced by SII (Already registered in Indonesia)
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
Time frame: 4 months
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
Time frame: 4 months
Immunogenicity of MR Vaccine in infants GMT
• Serological response to MR vaccine in infants: GMT
Time frame: up to 4 months
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.
Time frame: up to 4 months
Immunogenicity of MR Vaccine (seroconversion)
• Serological response to MR vaccine in infants: percentage of infants with transition of seronegative to seropositive.
Time frame: up to 4 months
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.
Time frame: up to 4 months
Comparison between each batch number of Bio Farma's MR vaccine.
• Serological response between each batch number of Bio Farma's MR vaccine.
Time frame: up to 4 months
Safety (immediate reactions)
• Immediate reactions within the first 30 minutes after vaccination
Time frame: up to 30 minutes after vaccination
Safety (72 hours)
• Local reactions and systemic events occurring within 72 h after vaccination.
Time frame: up to 72 hours after vaccination
Safety (14 days)
• Local reactions and systemic events occurring within 14 days after vaccination
Time frame: up to 14 days after vaccination
Safety (15 days to 28 days)
• Local reactions and systemic events occurring between 15 days to 28 days following injection.
Time frame: up to 14 days
Safety (Serious adverse event)
• Any serious adverse event occurring from inclusion until 28 days after immunization
Time frame: up to 1 months/28 days
Safety comparison between MR vaccine and control
• Description of adverse events between MR vaccine and control.
Time frame: up to 1 months/28 days
Safety comparison between each batch of MR vaccine
• Description of adverse events between each batch number of MR vaccine
Time frame: up to 1 months/28 days
Plan to share: No — no plan for IPD. Data are restricted to be used by investigators and sponsor only.
No publications or documents are linked to this record.
Ran from Sep 2019 to primary completion in Nov 2019, 2 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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