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Safety and Tuberculin Conversion Following BCG Vaccination

NCT05124340 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2022-09-19

No results posted yet for this study

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).

Conditions

  • BCG Vaccination Reaction

Interventions

BIOLOGICAL

BCG vial vaccine

Intradermal injection

BIOLOGICAL

BCG ampoule vaccine

Intradermal injection

Sponsors & Collaborators

  • Dr. Soetomo General Hospital

    collaborator OTHER_GOV

  • PT Bio Farma

    lead INDUSTRY

Principal Investigators

  • Dominicus Husada, MD · RS DR Soetomo Surabaya

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
1 Month
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2022-05-31
Completion
2022-07-30

Countries

  • Indonesia

Study Locations

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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 NCT05124340 on ClinicalTrials.gov