Congenital Rubella InfectionPhase 2/3NCT04183114
Immunogenicity & Safety of Bio Farma's Measles-Rubella (MR) Vaccine in Indonesian Infants (Bridging Study)
A Phase 2/3 study testing Measles-Rubella vaccine Bio Farma and MR Vaccine SII in people with Congenital Rubella Infection and Measles, run by PT Bio Farma at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Congenital Rubella Infection, Measles
- What is being tested?
- Measles-Rubella vaccine Bio Farma and MR Vaccine SII
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- 1 siteIndonesia
- Study dates
- 3 Sep 2019to 11 Nov 2019
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Child Health Dept. Dr. Soetomo Hospital, School of Medicine Airlangga Univ.
Surabaya, East Java, 60131
About this study
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.
Read the 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 .
- Conditions
- Congenital Rubella Infection, Measles
- Being tested
- Measles-Rubella vaccine Bio Farma, MR Vaccine SII
- Keywords
- Vaccine, Measles, Rubella, Bio Farma
- Medical subject headings
- Measles, Rubella
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measles-Rubella vaccine Bio FarmaBiological
Also called Vaksin Campak Rubella Bio Farma
MR vaccine produced by Bio Frama with 3 consecutive batches
MR Vaccine SIIBiological
MR Vaccine produced by SII (Already registered in Indonesia)
| Study group | Role | What they receive |
|---|---|---|
| IP batch MRUK-0317 | Experimental | 135 Subjects received Bio Farma's vaccine batch MRUK 0317 Receives: Biological: Measles-Rubella vaccine Bio Farma |
| IP Batch MRUK-0417 | Experimental | 135 Subjects received Bio Farma's vaccine batch MRUK 0417 Receives: Biological: Measles-Rubella vaccine Bio Farma |
| IP Batch 550118 | Experimental | 135 Subjects received Bio Farma's vaccine batch MRUK 0417 Receives: Biological: Measles-Rubella vaccine Bio Farma |
| Control | Active comparator | 135 Subjects received SII's MR vaccine batch 012W72230Z Receives: Biological: MR Vaccine SII |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 4 months
Secondary outcomes (12)
Immunogenicity of MR Vaccine in infants GMT
- Serological response to MR vaccine in infants: GMT
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 4 months
Safety (immediate reactions)
- Immediate reactions within the first 30 minutes after vaccination
Measured: up to 30 minutes after vaccination
Safety (72 hours)
- Local reactions and systemic events occurring within 72 h after vaccination.
Measured: up to 72 hours after vaccination
Safety (14 days)
- Local reactions and systemic events occurring within 14 days after vaccination
Measured: 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.
Measured: up to 14 days
Safety (Serious adverse event)
- Any serious adverse event occurring from inclusion until 28 days after immunization
Measured: up to 1 months/28 days
Safety comparison between MR vaccine and control
- Description of adverse events between MR vaccine and control.
Measured: 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
Measured: up to 1 months/28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start3 Sep 2019
- Primary completion11 Nov 2019
- Study completion11 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Rubella InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- healthy infants aged 9 - 12 months
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 540 participants (actual)
Sponsor and investigators
- Lead sponsor
- PT Bio Farma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04183114
- Sponsor's protocol ID
- MR-BF 0319
- Status last verified
- Dec 2019
- First submitted
- 28 Aug 2019
- Last updated
- 4 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan for IPD. Data are restricted to be used by investigators and sponsor only.
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity & Safety of Bio Farma's Measles-Rubella (MR) Vaccine in Indonesian Infants (Bridging Study)
- ClinicalTrials.gov ID
- NCT04183114
- Acronym / sponsor ID
- MR-BF 0319
- Conditions
- Congenital Rubella Infection, Measles
- Keywords
- Vaccine, Measles, Rubella, Bio Farma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 540 participants (actual)
- Lead sponsor
- PT Bio FarmaIndustry (pharma, biotech, devices)
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 11 Nov 2019 (actual)
- Study completion
- 11 Nov 2019 (actual)
- First posted
- 3 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- healthy infants aged 9 - 12 months
| Arm | Type | Receives |
|---|---|---|
| IP batch MRUK-0317 | Experimental | Biological: Measles-Rubella vaccine Bio Farma135 Subjects received Bio Farma's vaccine batch MRUK 0317 |
| IP Batch MRUK-0417 | Experimental | Biological: Measles-Rubella vaccine Bio Farma135 Subjects received Bio Farma's vaccine batch MRUK 0417 |
| IP Batch 550118 | Experimental | Biological: Measles-Rubella vaccine Bio Farma135 Subjects received Bio Farma's vaccine batch MRUK 0417 |
| Control | Active comparator | Biological: MR Vaccine SII135 Subjects received SII's MR vaccine batch 012W72230Z |
Who may qualify
- Ages
- 9 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measles-Rubella vaccine Bio FarmaAlso: Vaksin Campak Rubella Bio FarmaMR vaccine produced by Bio Frama with 3 consecutive batches | Biological | IP Batch 550118, IP Batch MRUK-0417, IP batch MRUK-0317 |
| MR Vaccine SIIMR Vaccine produced by SII (Already registered in Indonesia) | Biological | Control |
Primary outcome
Protectivity of Measles
Time frame: 4 months
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
Time frame: 4 months
Percentage of subjects with anti rubella titer ≥11 IU/ml, 28 days after one dose of Bio Farma's MR vaccine in Infants
12 secondary outcomes
Immunogenicity of MR Vaccine in infants GMT
Time frame: up to 4 months
Immunogenicity of MR Vaccine (4 Folds increase of antibody titer)
Time frame: up to 4 months
Immunogenicity of MR Vaccine (seroconversion)
Time frame: up to 4 months
Comparison Between MR (Bio Farma) Vaccine and Registered MR Vaccine
Time frame: up to 4 months
Comparison between each batch number of Bio Farma's MR vaccine.
Time frame: up to 4 months
Safety (immediate reactions)
Time frame: up to 30 minutes after vaccination
Safety (72 hours)
Time frame: up to 72 hours after vaccination
Safety (14 days)
Time frame: up to 14 days after vaccination
Safety (15 days to 28 days)
Time frame: up to 14 days
Safety (Serious adverse event)
Time frame: up to 1 months/28 days
Safety comparison between MR vaccine and control
Time frame: up to 1 months/28 days
Safety comparison between each batch of MR vaccine
Time frame: up to 1 months/28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2019.
- Individual participant dataSharing planned: No. no plan for IPD. Data are restricted to be used by investigators and sponsor only.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Measles-Rubella vaccine Bio Farma and MR Vaccine SII in people with Congenital Rubella Infection and Measles, run by PT Bio Farma at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protectivity of Measles (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2019.