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Clinical Trial Summary

The study is an bridging study, observer-blind, randomized, controlled prospective intervention study. The primary objective is evaluate the safety of BCG Vaccine Vial (Bio Farma).

Clinical Trial Description

This trial is bridging study, observer blinded, comparative, randomized study. Approximately 220 subjects will be recruited, 110 subjects are the investigational arm and 110 subjects are the active comparator arm. The objective of the study is to evaluate the safety of BCG Vaccine Vial (Bio Farma), and assess the the local and systemic reactions within 90 days after vaccination in each group, and assess the tuberculin conversion in each group. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05124340
Study type Interventional
Source PT Bio Farma
Contact Rini Mulia Sari, MD
Phone +622033755
Email [email protected]
Status Not yet recruiting
Phase Phase 2
Start date December 15, 2021
Completion date August 30, 2022

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