Safety and Tuberculin Conversion Following BCG Vaccination

BCG Vaccination Reaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05124340
• Other study ID #: BS BCG 0221
• Status: Completed
• Phase: Phase 2
• Start date: December 1, 2021
• Est. completion date: July 30, 2022

Study information

• Verified date: September 2022
• Source: PT Bio Farma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: July 30, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 1 Month

Eligibility

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.

Related Conditions & MeSH terms

• BCG Vaccination Reaction

Intervention

Biological:
• BCG vial vaccine
Intradermal injection
• BCG ampoule vaccine
Intradermal injection

Locations

Country	Name	City	State
Indonesia	Puskesmas Cerme	Gresik	Jawa Timur

Sponsors (2)

Lead Sponsor	Collaborator
PT Bio Farma	Dr. Soetomo General Hospital

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	To assess the tuberculin conversion in each group.	Number and percentage of subject who have tuberculin conversion	2 days