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

PT Bio Farma

Status and phase: Completed; Phase 3; Phase 2

Conditions: Measles; Congenital Rubella Infection

Treatments: Biological: MR Vaccine SII; Biological: Measles-Rubella vaccine Bio Farma

Study type: Interventional

Funder types: Industry

Identifiers

NCT04183114

MR-BF 0319

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 540 patients

Sex: All

Ages: 9 to 12 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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540 participants in 4 patient groups

IP batch MRUK-0317

Experimental group

Description:

135 Subjects received Bio Farma's vaccine batch MRUK 0317

Treatment:

Biological: Measles-Rubella vaccine Bio Farma

IP Batch MRUK-0417

Experimental group

Description:

135 Subjects received Bio Farma's vaccine batch MRUK 0417

Treatment:

Biological: Measles-Rubella vaccine Bio Farma

IP Batch 550118

Experimental group

Description:

135 Subjects received Bio Farma's vaccine batch MRUK 0417

Treatment:

Biological: Measles-Rubella vaccine Bio Farma

Control

Active Comparator group

Description:

135 Subjects received SII's MR vaccine batch 012W72230Z

Treatment:

Biological: MR Vaccine SII