Immunogenicity & Safety of Bio Farma's Measles-Rubella (MR) Vaccine in Indonesian Infants (Bridging Study)

December 2, 2019 updated by: PT Bio Farma
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
540

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • East Java
      • Surabaya, East Java, Indonesia, 60131
        • Child Health Dept. Dr. Soetomo Hospital, School of Medicine Airlangga Univ.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

9 months to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Healthy Infants, 9-12 months
  2. Parents have been informed properly regarding the study and signed the informed consent form
  3. Parents will commit themselves to comply with the instructions of the investigator and the schedule of the trial.

Exclusion Criteria:

  1. Subject concomitantly enrolled or scheduled to be enrolled in another trial.
  2. Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature > 37.5 Centigrade).
  3. Known history of allergy to neomycin, kanamycin or erythromycin or any component of the vaccines.
  4. History of immunodeficiency disorder or disorders like HIV infection, leukemia, lymphoma, or generalized malignancy that can alter immune response.
  5. Subjects who have previously received any measles and/or rubella containing vaccines.
  6. Subjects who had a clinical history of measles/rubella infection.
  7. 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).
  8. Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.
  9. Subject already immunized with any vaccine within 4 weeks prior vaccination.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: IP batch MRUK-0317
135 Subjects received Bio Farma's vaccine batch MRUK 0317
Biological: Measles-Rubella vaccine Bio Farma
MR vaccine produced by Bio Frama with 3 consecutive batches
Other Names:
  • Vaksin Campak Rubella Bio Farma
Experimental: IP Batch MRUK-0417
135 Subjects received Bio Farma's vaccine batch MRUK 0417
Biological: Measles-Rubella vaccine Bio Farma
MR vaccine produced by Bio Frama with 3 consecutive batches
Other Names:
  • Vaksin Campak Rubella Bio Farma
Experimental: IP Batch 550118
135 Subjects received Bio Farma's vaccine batch MRUK 0417
Biological: Measles-Rubella vaccine Bio Farma
MR vaccine produced by Bio Frama with 3 consecutive batches
Other Names:
  • Vaksin Campak Rubella Bio Farma
Active Comparator: Control
135 Subjects received SII's MR vaccine batch 012W72230Z
Biological: MR Vaccine SII
MR Vaccine produced by SII (Already registered in Indonesia)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
4 months
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
4 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Immunogenicity of MR Vaccine in infants GMT
Time Frame: up to 4 months
• Serological response to MR vaccine in infants: GMT
up to 4 months
Immunogenicity of MR Vaccine (4 Folds increase of antibody titer)
Time Frame: up to 4 months
• Serological response to MR vaccine in infants: percentage of infants with increasing antibody titer > 4 times.
up to 4 months
Immunogenicity of MR Vaccine (seroconversion)
Time Frame: up to 4 months
• Serological response to MR vaccine in infants: percentage of infants with transition of seronegative to seropositive.
up to 4 months
Comparison Between MR (Bio Farma) Vaccine and Registered MR Vaccine
Time Frame: up to 4 months
• 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.
up to 4 months
Comparison between each batch number of Bio Farma's MR vaccine.
Time Frame: up to 4 months
• Serological response between each batch number of Bio Farma's MR vaccine.
up to 4 months
Safety (immediate reactions)
Time Frame: up to 30 minutes after vaccination
• Immediate reactions within the first 30 minutes after vaccination
up to 30 minutes after vaccination
Safety (72 hours)
Time Frame: up to 72 hours after vaccination
• Local reactions and systemic events occurring within 72 h after vaccination.
up to 72 hours after vaccination
Safety (14 days)
Time Frame: up to 14 days after vaccination
• Local reactions and systemic events occurring within 14 days after vaccination
up to 14 days after vaccination
Safety (15 days to 28 days)
Time Frame: up to 14 days
• Local reactions and systemic events occurring between 15 days to 28 days following injection.
up to 14 days
Safety (Serious adverse event)
Time Frame: up to 1 months/28 days
• Any serious adverse event occurring from inclusion until 28 days after immunization
up to 1 months/28 days
Safety comparison between MR vaccine and control
Time Frame: up to 1 months/28 days
• Description of adverse events between MR vaccine and control.
up to 1 months/28 days
Safety comparison between each batch of MR vaccine
Time Frame: up to 1 months/28 days
• Description of adverse events between each batch number of MR vaccine
up to 1 months/28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
PT Bio Farma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 3, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 11, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 11, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 28, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 3, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MR-BF 0319

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

no plan for IPD. Data are restricted to be used by investigators and sponsor only.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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