NCT01977196已完成1 期
Phase 1 of DTP/Hepatitis B 10ug Hib Vaccine
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- PT Bio Farma
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Incidence rate of adverse event of DTP/Hepatitis B/Hib vaccine (Bio Farma)
研究概览
简要总结
The objective of this study was to know the safety of DTP/Hepatitis B and Hib/PRP-T vaccine and immediate reactions within the first 30 minutes after injection.
详细描述
This trial was an open-label study, no randomization, and no placebo or control group. Total 30 healthy infants (age 6-11 weeks) followed this trial. The safety was assessed within 24 hours, 48 hours, 72 hours, and 28 days after injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Weeks 至 11 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infant 6-11 week of age
- •Infant born after 37-42 week of pregnancy
- •Infant weighting more than 2.5 kg at birth
- •Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form
- •Parents commit themselves to comply with the indication of the investigator and with the schedule of the trial
排除标准
- •Child concomitantly enroll or schedule to be enroll in another trial
- •Evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature >=37.5 Celsius on Day 0)
- •Known history of allergy to any component of the vaccine component (e.g.formaldehyde)
- •History of uncontrolled coagulopathy or blood disorder contraindicating intramuscular injection
- •Known history of congenital or acquired immunodeficiency (including HIV infection)
- •Child who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulin, blood derived product or long term corticotherapy (>2 minggu)
- •Other vaccination within the 7 days prior to inclusion with the exception of BCG and poliomyelitis
- •Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objective
- •Infant with a known history of diphteria, tetanus, pertussis, Hib, Hepatitis B infection
结局指标
主要结局
Incidence rate of adverse event of DTP/Hepatitis B/Hib vaccine (Bio Farma)
时间窗: 30 minutes
Local and systemic reactions
次要结局
- Incidence rate of adverse event of DTP/Hepatitis B/Hib vaccine (Bio Farma)(28 hours, 48 hours, 72 hours, 28 days)
- To asses the immunogenicity(28 days)
研究者
研究点 (2)
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