Safety and Tuberculin Conversion Following BCG Vaccination

Safety and Tuberculin Conversion Following BCG Vaccine Vial (Bio Farma) Compared to Registered BCG Vaccine (Bio Farma) in Indonesian Infants

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).

Study Overview

• Status: Completed
• Conditions: BCG Vaccination Reaction
• Intervention / Treatment: Biological: BCG vial vaccine; Biological: BCG ampoule vaccine

Detailed 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 Type: Interventional
• Enrollment (Actual): 220
• Phase: Phase 2

Contacts and Locations

Study Locations

• Indonesia
  • Jawa Timur
    • Gresik, Jawa Timur, Indonesia
      • Puskesmas Cerme

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 month (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy infant aged 0-1 month.
2. Infants born after 37-42 weeks of pregnancy.
3. Infant weighing 2500 gram or more at birth.
4. Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form.
5. Parents will commit themselves to comply with the instructions of the investigator and with the schedule of the trial.

Exclusion Criteria:

1. Child concomitantly enrolled or scheduled to be enrolled in another trial.
2. Evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature 37.5 celcius degrees).
3. Suspected of allergy to any component of the vaccines.
4. Newborn suspected of congenital or acquired immunodeficiency.
5. Received or plans to receive any treatment likely to alter the immune response intravenous (immunoglobulins, blood-derived products or long term corticotherapy (> 2 weeks)).
6. Received other vaccination with the exception of OPV and Hepatitis B vaccine.
7. Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.
8. Any skin disease such eczema generalisata other skin infection which makes difficult the assessment of the local reactios.
9. Mothers with HbsAg and HIV positive (by rapid test)
10. Parents planning to move from the study area before the end of study period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vaccine; 1 dose of BCG vial vaccine injected in right deltoid armintradermally	Biological: BCG vial vaccine; Intradermal injection
Active Comparator: Active Comparator; 1 dose of BCG ampoule vaccine injected in right deltoid arm intradermally	Biological: BCG ampoule vaccine; Intradermal injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the safety of BCG Vaccine Vial (Bio Farma)	Number and percentage of subject experience local reactions and systemic events occurring within 30 minutes after vaccination.	30 minutes after vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the local and systemic reactions within 30 minutes, 24 hours, 48 hours, 72 hours, 7 days and 30 days after vaccination.	Number and percentage of subject experience ;ocal reactions and systemic events occurring within 24 hours, 48 hours, 72 hours, 7 days and 30 days after vaccination will be assessed per group with 95% CI.	30 days after vaccination
To assess local reactions at 60 days and 90 days after vaccination in each group.	Number and percentage of subject experience local reactions at 60 days and 90 days after vaccination will be assessed per group with 95% CI.	90 days after vaccination
To assess serious adverse events within 30 days after vaccinantion in each group.	Number and percentage of subject experience Serious Adverse Events within 30 days after vaccination will be described.	30 days
To assess the tuberculin conversion in each group.	Number and percentage of subject who have tuberculin conversion	2 days

Collaborators and Investigators

• Sponsor: PT Bio Farma
• Collaborators: Dr. Soetomo General Hospital
• Investigators: Principal Investigator: Dominicus Husada, MD, RS DR Soetomo Surabaya

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): July 30, 2022

Study Registration Dates

• First Submitted: October 26, 2021
• First Submitted That Met QC Criteria: November 7, 2021
• First Posted (Actual): November 17, 2021

Study Record Updates

• Last Update Posted (Actual): September 19, 2022
• Last Update Submitted That Met QC Criteria: September 15, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: BCG Vaccine; Safety of BCG Vaccine; Tuberculin Conversion
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: BS BCG 0221

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No