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).
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
220
Intradermal injection
Intradermal injection
Puskesmas Cerme
Gresik, East Java, Indonesia
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.
Time frame: 30 minutes after vaccination
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.
Time frame: 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.
Time frame: 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.
Time frame: 30 days
To assess the tuberculin conversion in each group.
Number and percentage of subject who have tuberculin conversion
Time frame: 2 days
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