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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

540 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-03

Study Completion Date

2019-11-11

Brief Summary

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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.

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Detailed Description

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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

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Congenital Rubella Infection Measles

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

healthy infants aged 9 - 12 months

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

The masking uses observer blind with some unmasked staff to prepare the vaccine to be administered by masked investigator.

Study Groups

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IP batch MRUK-0317

135 Subjects received Bio Farma's vaccine batch MRUK 0317

Group Type EXPERIMENTAL

Measles-Rubella vaccine Bio Farma

Intervention Type BIOLOGICAL

MR vaccine produced by Bio Frama with 3 consecutive batches

IP Batch MRUK-0417

135 Subjects received Bio Farma's vaccine batch MRUK 0417

Group Type EXPERIMENTAL

Measles-Rubella vaccine Bio Farma

Intervention Type BIOLOGICAL

MR vaccine produced by Bio Frama with 3 consecutive batches

IP Batch 550118

135 Subjects received Bio Farma's vaccine batch MRUK 0417

Group Type EXPERIMENTAL

Measles-Rubella vaccine Bio Farma

Intervention Type BIOLOGICAL

MR vaccine produced by Bio Frama with 3 consecutive batches

Control

135 Subjects received SII's MR vaccine batch 012W72230Z

Group Type ACTIVE_COMPARATOR

MR Vaccine SII

Intervention Type BIOLOGICAL

MR Vaccine produced by SII (Already registered in Indonesia)

Interventions

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Measles-Rubella vaccine Bio Farma

MR vaccine produced by Bio Frama with 3 consecutive batches

Intervention Type BIOLOGICAL

MR Vaccine SII

MR Vaccine produced by SII (Already registered in Indonesia)

Intervention Type BIOLOGICAL

Other Intervention Names

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Vaksin Campak Rubella Bio Farma

Eligibility Criteria

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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.

Minimum Eligible Age

9 Months

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes