Safety and Tuberculin Conversion Following BCG Vaccination

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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BCG Vaccination Reaction

Intervention / Treatment
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* Biological: BCG vial vaccine
* Biological: BCG ampoule vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy infant aged 0-1 month. Infants born after 37-42 weeks of pregnancy. Infant weighing 2500 gram or more at birth. Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form. Parents will commit themselves to comply with the instructions of the investigator and with the schedule of the trial. Exclusion Criteria: Child concomitantly enrolled or scheduled to be enrolled in another trial. Evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature 37.5 celcius degrees). Suspected of allergy to any component of the vaccines. Newborn suspected of congenital or acquired immunodeficiency. Received or plans to receive any treatment likely to alter the immune response intravenous (immunoglobulins, blood-derived products or long term corticotherapy (> 2 weeks)). Received other vaccination with the exception of OPV and Hepatitis B vaccine. Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives. Any skin disease such eczema generalisata other skin infection which makes difficult the assessment of the local reactios. Mothers with HbsAg and HIV positive (by rapid test) Parents planning to move from the study area before the end of study period.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 1 Month

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaccine<br>1 dose of BCG vial vaccine injected in right deltoid armintradermally | Biological: BCG vial vaccine<br>* Intradermal injection<br>|
| Active Comparator: Active Comparator<br>1 dose of BCG ampoule vaccine injected in right deltoid arm intradermally | Biological: BCG ampoule vaccine<br>* Intradermal injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| To assess the tuberculin conversion in each group. | Number and percentage of subject who have tuberculin conversion | 2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BCG Vaccine, Safety of BCG Vaccine, Tuberculin Conversion