NCT04183114

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 540 (actual)
• Sponsor: PT Bio Farma · Industry
• Sex: All
• Age: 9 Months – 12 Months
• Healthy volunteers: Accepted

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 .

Conditions

• Congenital Rubella Infection
• Measles

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2019-09-03
• Primary completion: 2019-11-11
• Completion: 2019-11-11
• First posted: 2019-12-03
• Last updated: 2019-12-04

Locations

1 site across 1 country: Indonesia