Safety and Tuberculin Conversion Following BCG Vaccination

• Sponsor: PT Bio Farma (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05124340
• Collaborator: Dr. Soetomo General Hospital (Other)
• Enrollment: 220
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 8.9
• Patients Per Site Per Month: 24.6

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
BCG Vaccination Reaction	Biological: BCG vial vaccine; Biological: BCG ampoule vaccine	Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 220 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Masking Description: Observer Blind : Investigational Product and Active Comparator are masking. Lot number is masking
• Primary Purpose: Prevention
• Official Title: Safety and Tuberculin Conversion Following BCG Vaccine Vial (Bio Farma) Compared to Registered BCG Vaccine (Bio Farma) in Indonesian Infants
• Actual Study Start Date: Dec 1, 2021
• Anticipated Primary Completion Date: May 31, 2022
• Anticipated Study Completion Date: Aug 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. To evaluate the safety of BCG Vaccine Vial (Bio Farma) [30 minutes after vaccination]

   Number and percentage of subject experience local reactions and systemic events occurring within 30 minutes after vaccination.

Secondary Outcome Measures

1. To assess the local and systemic reactions within 30 minutes, 24 hours, 48 hours, 72 hours, 7 days and 30 days after vaccination. [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.

2. To assess local reactions at 60 days and 90 days after vaccination in each group. [90 days after vaccination]

   Number and percentage of subject experience local reactions at 60 days and 90 days after vaccination will be assessed per group with 95% CI.

3. To assess serious adverse events within 30 days after vaccinantion in each group. [30 days]

   Number and percentage of subject experience Serious Adverse Events within 30 days after vaccination will be described.

4. To assess the tuberculin conversion in each group. [2 days]

   Number and percentage of subject who have tuberculin conversion

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Day to 1 Month
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Puskesmas Cerme	Gresik	Jawa Timur	Indonesia

Sponsors and Collaborators

• PT Bio Farma
• Dr. Soetomo General Hospital

Investigators

• Principal Investigator: Dominicus Husada, MD, RS DR Soetomo Surabaya

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: PT Bio Farma
• ClinicalTrials.gov Identifier: NCT05124340
• Other Study ID Numbers: BS BCG 0221
• First Posted: Nov 17, 2021
• Last Update Posted: Dec 16, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by PT Bio Farma: BCG Vaccine; Safety of BCG Vaccine; Tuberculin Conversion
• Additional relevant MeSH terms: Vaccines

Study Results

No Results Posted as of Dec 16, 2021