Safety IssuesPhase 4NCT03680417
Reactogenicity and Protectivity Following Measles- Rubella (MR) Routine Immunization in Indonesian Infants and Children
A Phase 4 study testing Measles-Rubella (MR) Vaccine in people with Safety Issues and Immunogenicity, run by PT Bio Farma at 1 site in Indonesia.
Trial summary
to assess safety and immunogenicity of measles-rubella (MR) routine immunization in Indonesian Children and Infants Read more about this study
- Who is it for?
- Ages 9 to 47 monthsHealthy volunteers can take part
- Conditions the study is for
- Safety Issues, Immunogenicity
- What is being tested?
- Measles-Rubella (MR) Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 590 participants
- Where
- 1 siteIndonesia
- Study dates
- 16 Nov 2017to 1 Aug 2018
- Phase
- Phase 4
- 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 47 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- MR vaccine given simultaneously with other vaccination, except Pentabio (DTP/HB/Hib)
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
to assess safety and immunogenicity of measles-rubella (MR) routine immunization in Indonesian Children and Infants
Read the 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
- Conditions
- Safety Issues, Immunogenicity
- Being tested
- Measles-Rubella (MR) Vaccine
- Keywords
- Measles-Rubella, Vaccine, Safety, Immunogenicity, Reactogenicity, Protectivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measles-Rubella (MR) VaccineBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Safety Study (Measles-Rubella vaccine) | Active comparator | 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. Receives: Biological: Measles-Rubella (MR) Vaccine |
| Sub Study (Measles-Rubella vaccine) | Active comparator | 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. Receives: Biological: Measles-Rubella (MR) Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Immediate systemic events
Number of subjects with at least one serious immediate systemic events within 30 minutes after vaccination
Measured: 30 minutes
Percentage of immediate systemic events
Percentage of subjects with at least one serious immediate systemic events within 30 minutes after vaccination
Measured: 30 minutes
Secondary outcomes (15)
Local reaction
Number of subjects with at least one local reaction occurring within 72 h after vaccination.
Measured: 72 hours
Systemic reaction
Number of subjects with at least one systemic event occurring within 72 h after vaccination.
Measured: 72 hours
Delayed Local reaction
Number of subjects with at least one local reaction occurring between day 4-14 after vaccination.
Measured: 11 days
Delayed systemic event
Number of subjects with at least one systemic event occurring between day 4-14 after vaccination.
Measured: 11 days
Late Local reaction
-Number of subjects with at least one systemic event occurring between day 15 to 28 following vaccination.
Measured: 14 days
Late Safety (Systemic event)
Number of subjects with at least one systemic event occurring between day 15 to 28 following vaccination.
Measured: 14 days
Safety (serious adverse event)
- Number of serious adverse event occuring from inclusion until 28 days after immunization
Measured: 28 days
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.
Measured: 28 days
Immunogenicity for Measles (Geometric Mean Titer)
- Geometric Mean Titer of measles antibody
Measured: 28 days
Immunogenicity for Measles (increasing measles antibody titer ≥ 4 times)
- Percentage of infants with increasing measles antibody titer ≥ 4 times
Measured: 28 days
Immunogenicity for Measles (seroconversion from seronegative to seropositive)
- Percentage of infants with transition of seronegative to seropositive.
Measured: 28 days
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.
Measured: 28 days
Immunogenicity for Rubella (Geometric Mean Titer)
- Geometric Mean Titer of Rubella antibody.
Measured: 28 days
Immunogenicity for Rubella (increasing rubella antibody titer ≥ 4 times)
- Percentage of infants with increasing rubella antibody titer ≥ 4 times
Measured: 28 days
Immunogenicity for Rubella (seroconversion from seronegative to seropositive)
- Percentage of infants with transition of seronegative to seropositive.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2018
- Study start16 Nov 2017
- Primary completion26 Feb 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 590 participants (actual)
Sponsor and investigators
- Lead sponsor
- PT Bio Farma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dominicus Husada, Dr, Principal investigator, Child Health Dept. Dr. Soetomo Hospital/School of Medicine, Airlangga Univ.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03680417
- Sponsor's protocol ID
- PMS-MR-0417
- Status last verified
- Sep 2019
- First submitted
- 18 Sep 2018
- Last updated
- 12 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reactogenicity and Protectivity Following Measles- Rubella (MR) Routine Immunization in Indonesian Infants and Children
- ClinicalTrials.gov ID
- NCT03680417
- Acronym / sponsor ID
- PMS-MR-0417
- Conditions
- Safety Issues, Immunogenicity
- Keywords
- Measles-Rubella, Vaccine, Safety, Immunogenicity, Reactogenicity, Protectivity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 590 participants (actual)
- Lead sponsor
- PT Bio FarmaIndustry (pharma, biotech, devices)
- Study start
- 16 Nov 2017 (actual)
- Primary completion
- 26 Feb 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 21 Sep 2018 (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.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Safety Study (Measles-Rubella vaccine) | Active comparator | Biological: Measles-Rubella (MR) Vaccineopen 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. |
| Sub Study (Measles-Rubella vaccine) | Active comparator | Biological: Measles-Rubella (MR) Vaccineopen 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. |
Who may qualify
- Ages
- 9 to 47 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- MR vaccine given simultaneously with other vaccination, except Pentabio (DTP/HB/Hib)
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 (MR) VaccineMeasles 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. | Biological | Safety Study (Measles-Rubella vaccine), Sub Study (Measles-Rubella vaccine) |
Primary outcome
Number of Immediate systemic events
Time frame: 30 minutes
Number of subjects with at least one serious immediate systemic events within 30 minutes after vaccination
Percentage of immediate systemic events
Time frame: 30 minutes
Percentage of subjects with at least one serious immediate systemic events within 30 minutes after vaccination
15 secondary outcomes
Local reaction
Time frame: 72 hours
Systemic reaction
Time frame: 72 hours
Delayed Local reaction
Time frame: 11 days
Delayed systemic event
Time frame: 11 days
Late Local reaction
Time frame: 14 days
Late Safety (Systemic event)
Time frame: 14 days
Safety (serious adverse event)
Time frame: 28 days
Immunogenicity for Measles (subject with anti measles titer ≥ 8 (1/dil))
Time frame: 28 days
Immunogenicity for Measles (Geometric Mean Titer)
Time frame: 28 days
Immunogenicity for Measles (increasing measles antibody titer ≥ 4 times)
Time frame: 28 days
Immunogenicity for Measles (seroconversion from seronegative to seropositive)
Time frame: 28 days
Immunogenicity for Rubella (Subjects with anti rubella titer ≥11 IU/ml)
Time frame: 28 days
Immunogenicity for Rubella (Geometric Mean Titer)
Time frame: 28 days
Immunogenicity for Rubella (increasing rubella antibody titer ≥ 4 times)
Time frame: 28 days
Immunogenicity for Rubella (seroconversion from seronegative to seropositive)
Time frame: 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 12 Sep 2019.
- Individual participant dataSharing planned: No
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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.
Dominicus Husada, Dr principal investigator
Child Health Dept. Dr. Soetomo Hospital/School of Medicine, Airlangga Univ.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Measles-Rubella (MR) Vaccine in people with Safety Issues and Immunogenicity, 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 4 inclusion and 1 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 12 Sep 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Number of Immediate systemic events (time frame: 30 minutes). 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 12 Sep 2019.