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

2019-12-06 00:24:51 | BioPortfolio

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.

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 Design

Conditions

Congenital Rubella Infection

Intervention

Measles-Rubella vaccine Bio Farma, MR Vaccine SII

Location

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

Status

Completed

Source

PT Bio Farma

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-12-06T00:24:51-0500

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