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

NCT04183114 | Completed Phase 2 DMC

• 1 other identifier: MR-BF 0319
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Congenital Rubella Infection; Measles

Keywords

Vaccine; Measles; Rubella; Bio Farma

Outcome Measures

Primary Outcomes (2)

• 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

  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

  4 months

Secondary Outcomes (12)

• Immunogenicity of MR Vaccine in infants GMT

  up to 4 months

• Immunogenicity of MR Vaccine (4 Folds increase of antibody titer)

  up to 4 months

• Immunogenicity of MR Vaccine (seroconversion)

  up to 4 months

• Comparison Between MR (Bio Farma) Vaccine and Registered MR Vaccine

  up to 4 months

• Comparison between each batch number of Bio Farma's MR vaccine.

  up to 4 months

Study Arms (4)

IP batch MRUK-0317

EXPERIMENTAL

135 Subjects received Bio Farma's vaccine batch MRUK 0317

Biological: Measles-Rubella vaccine Bio Farma

IP Batch MRUK-0417

EXPERIMENTAL

135 Subjects received Bio Farma's vaccine batch MRUK 0417

Biological: Measles-Rubella vaccine Bio Farma

IP Batch 550118

EXPERIMENTAL

135 Subjects received Bio Farma's vaccine batch MRUK 0417

Biological: Measles-Rubella vaccine Bio Farma

Control

ACTIVE COMPARATOR

135 Subjects received SII's MR vaccine batch 012W72230Z

Biological: MR Vaccine SII

Interventions

Measles-Rubella vaccine Bio Farma BIOLOGICAL

MR vaccine produced by Bio Frama with 3 consecutive batches

Also known as: Vaksin Campak Rubella Bio Farma

IP Batch 550118; IP Batch MRUK-0417; IP batch MRUK-0317

MR Vaccine SII BIOLOGICAL

MR Vaccine produced by SII (Already registered in Indonesia)

Control

Eligibility Criteria

• Age: 9 Months - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• PT Bio Farma: lead

Study Sites (1)

Child Health Dept. Dr. Soetomo Hospital, School of Medicine Airlangga Univ.

Surabaya, East Java, 60131, Indonesia

Location

MeSH Terms

Conditions

Measles; Rubella

Condition Hierarchy (Ancestors)

Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections; Rubivirus Infections; Togaviridae Infections

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The masking uses observer blind with some unmasked staff to prepare the vaccine to be administered by masked investigator.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: healthy infants aged 9 - 12 months

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: December 3, 2019
• Study Start: September 3, 2019
• Primary Completion: November 11, 2019
• Study Completion: November 11, 2019
• Last Updated: December 4, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)