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

NCT04183114 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 540

Last updated 2019-12-04

No results posted yet for this study

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

Interventions

BIOLOGICAL

Measles-Rubella vaccine Bio Farma

MR vaccine produced by Bio Frama with 3 consecutive batches

BIOLOGICAL

MR Vaccine SII

MR Vaccine produced by SII (Already registered in Indonesia)

Sponsors & Collaborators

  • PT Bio Farma

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
9 Months
Max Age
12 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-03
Primary Completion
2019-11-11
Completion
2019-11-11

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04183114 on ClinicalTrials.gov