Clinical trial NCT05124340: Safety and Tuberculin Conversion Following BCG Vaccination
Official title: Safety and Tuberculin Conversion Following BCG Vaccine Vial (Bio Farma) Compared to Registered BCG Vaccine (Bio Farma) in Indonesian Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: BCG Vaccination Reaction
Keywords: BCG Vaccine
Safety of BCG Vaccine
Tuberculin Conversion
Lead sponsor: PT Bio Farma
Sponsor class: INDUSTRY
Collaborators: name: Dr. Soetomo General Hospital
First posted: 2021-11-17
Enrollment: 220
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To evaluate the safety of BCG Vaccine Vial (Bio Farma)
timeFrame: 30 minutes after vaccination
Secondary outcomes:
measure: To assess the local and systemic reactions within 30 minutes, 24 hours, 48 hours, 72 hours, 7 days and 30 days after vaccination.
timeFrame: 30 days after vaccination
measure: To assess local reactions at 60 days and 90 days after vaccination in each group.
timeFrame: 90 days after vaccination
measure: To assess serious adverse events within 30 days after vaccinantion in each group.
timeFrame: 30 days
measure: To assess the tuberculin conversion in each group.
timeFrame: 2 days
Other outcomes:
Locations:
city: Gresik
country: Indonesia
facility: Puskesmas Cerme
state: Jawa Timur
Study officials:
affiliation: RS DR Soetomo Surabaya
name: Dominicus Husada, MD
role: PRINCIPAL_INVESTIGATOR
References: