BCG Vaccination Reaction
Conditions
Keywords
BCG Vaccine, Safety of BCG Vaccine, Tuberculin Conversion
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.
Interventions
BIOLOGICALBCG vial vaccine
Intradermal injection
BIOLOGICALBCG ampoule vaccine
Intradermal injection
Sponsors
Dr. Soetomo General Hospital
PT Bio Farma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
Observer Blind : Investigational Product and Active Comparator are masking. Lot number is masking
Eligibility
Sex/Gender
ALL
Age
1 Days to 1 Months
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| To assess the tuberculin conversion in each group. | 2 days | Number and percentage of subject who have tuberculin conversion |
Countries
Indonesia
Outcome results
None listed