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

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: Completed
• Conditions: Measles; Congenital Rubella Infection
• Intervention / Treatment: Biological: Measles-Rubella vaccine Bio Farma; Biological: MR Vaccine SII

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: Interventional
• Enrollment (Actual): 540
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity of MR Vaccine in infants GMT	• Serological response to MR vaccine in infants: GMT	up to 4 months
Immunogenicity of MR Vaccine (4 Folds increase of antibody titer)	• 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)	• 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	• 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.	• Serological response between each batch number of Bio Farma's MR vaccine.	up to 4 months
Safety (immediate reactions)	• Immediate reactions within the first 30 minutes after vaccination	up to 30 minutes after vaccination
Safety (72 hours)	• Local reactions and systemic events occurring within 72 h after vaccination.	up to 72 hours after vaccination
Safety (14 days)	• Local reactions and systemic events occurring within 14 days after vaccination	up to 14 days after vaccination
Safety (15 days to 28 days)	• Local reactions and systemic events occurring between 15 days to 28 days following injection.	up to 14 days
Safety (Serious adverse event)	• 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	• Description of adverse events between MR vaccine and control.	up to 1 months/28 days
Safety comparison between each batch of MR vaccine	• Description of adverse events between each batch number of MR vaccine	up to 1 months/28 days

Collaborators and Investigators

• Sponsor: PT Bio Farma

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2019
• Primary Completion (Actual): November 11, 2019
• Study Completion (Actual): November 11, 2019

Study Registration Dates

• First Submitted: August 28, 2019
• First Submitted That Met QC Criteria: November 27, 2019
• First Posted (Actual): December 3, 2019

Study Record Updates

• Last Update Posted (Actual): December 4, 2019
• Last Update Submitted That Met QC Criteria: December 2, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Vaccine; Measles; Rubella; Bio Farma
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; Togaviridae Infections; Rubivirus Infections; Measles; Rubella; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID 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