Safety and Tuberculin Conversion Following BCG Vaccine Vial (Bio Farma) Compared to Registered BCG Vaccine (Bio Farma) in Indonesian Infants
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- PT Bio Farma
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- To evaluate the safety of BCG Vaccine Vial (Bio Farma)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
Observer Blind : Investigational Product and Active Comparator are masking. Lot number is masking
入排标准
- 年龄范围
- 1 Day 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
To evaluate the safety of BCG Vaccine Vial (Bio Farma)
时间窗: 30 minutes after vaccination
Number and percentage of subject experience local reactions and systemic events occurring within 30 minutes after vaccination.
次要结局
- To assess serious adverse events within 30 days after vaccinantion in each group.(30 days)
- 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)
- To assess local reactions at 60 days and 90 days after vaccination in each group.(90 days after vaccination)
- To assess the tuberculin conversion in each group.(2 days)