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

Phase 2

Completed

• Conditions: Measles; Congenital Rubella Infection
• Interventions: Biological: Measles-Rubella vaccine Bio Farma; Biological: MR Vaccine SII

• Registration Number: NCT04183114
• Lead Sponsor: PT Bio Farma

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.

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 Timeline

• Study First Submitted: 2019-08-28
• Study Start: 2019-09-03
• Primary Completion: 2019-11-11
• Study Completion: 2019-11-11
• Study First Submitted QC: 2019-11-27
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-02
• Study First Posted: 2019-12-03
• Last Update Posted: 2019-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 540

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IP Batch MRUK-0417	Measles-Rubella vaccine Bio Farma	135 Subjects received Bio Farma's vaccine batch MRUK 0417
IP Batch 550118	Measles-Rubella vaccine Bio Farma	135 Subjects received Bio Farma's vaccine batch MRUK 0417
Control	MR Vaccine SII	135 Subjects received SII's MR vaccine batch 012W72230Z
IP batch MRUK-0317	Measles-Rubella vaccine Bio Farma	135 Subjects received Bio Farma's vaccine batch MRUK 0317

Primary Outcome Measures

Name	Time	Method
Protectivity of Measles	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
Protectivity of Rubella	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

Secondary Outcome Measures

Name	Time	Method
Safety (14 days)	up to 14 days after vaccination	• Local reactions and systemic events occurring within 14 days after vaccination
Safety comparison between MR vaccine and control	up to 1 months/28 days	• Description of adverse events between MR vaccine and control.
Safety (immediate reactions)	up to 30 minutes after vaccination	• Immediate reactions within the first 30 minutes after vaccination
Safety (72 hours)	up to 72 hours after vaccination	• Local reactions and systemic events occurring within 72 h after vaccination.
Safety (15 days to 28 days)	up to 14 days	• Local reactions and systemic events occurring between 15 days to 28 days following injection.
Safety (Serious adverse event)	up to 1 months/28 days	• Any serious adverse event occurring from inclusion until 28 days after immunization
Safety comparison between each batch of MR vaccine	up to 1 months/28 days	• Description of adverse events between each batch number of MR vaccine
Comparison between each batch number of Bio Farma's MR vaccine.	up to 4 months	• Serological response between each batch number of Bio Farma's MR vaccine.
Immunogenicity of MR Vaccine in infants GMT	up to 4 months	• Serological response to MR vaccine in infants: GMT
Immunogenicity of MR Vaccine (4 Folds increase of antibody titer)	up to 4 months	• Serological response to MR vaccine in infants: percentage of infants with increasing antibody titer \> 4 times.
Immunogenicity of MR Vaccine (seroconversion)	up to 4 months	• Serological response to MR vaccine in infants: percentage of infants with transition of seronegative to seropositive.
Comparison Between MR (Bio Farma) Vaccine and Registered MR Vaccine	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.

Trial Locations

Locations (1)

Child Health Dept. Dr. Soetomo Hospital, School of Medicine Airlangga Univ.; 🇮🇩 Surabaya, East Java, Indonesia