NCT02257645Unknown不适用
A Multicenter, Post-authorization Safety Study of Euforvac-Hib Vaccine for Active Primary Immunization Against Diphtheria, Tetanus, Pertussis, Hepatitis B and Haemophilus Influenza Type B in Infants
LG Life Sciences0 个研究点目标入组 3,000 人开始时间: 2015年3月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 3,000
- 主要终点
- Adverse event
研究概览
简要总结
A multicenter, observational study to evaluate the safety of Euforvac-Hib vaccine for active primary immunization against diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenza type B in infants.
详细描述
Euforvac-Hib vaccine manufactured by LG Life science in Korea, but it's not marketed in Korea. It is distributed to UN agencies in diverse countries. Thus, WHO recommended LG Life Science to conduct the safety study for assessing the vaccine safety if Euforvac-Hib is prequalified.
The objectives of this safety study are to identify any problems and questionable issues likely to emerge from the actual use of Euforvac-Hib vaccine after launching in the market.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Weeks 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who had been signed informed consent by subjects legally acceptable Representative
- •Infant from 6 weeks of age.who is given this vaccine for active primary immunization against diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenza type B
排除标准
- •Patients with hypersensitivity to any component for the vaccine
- •Patients who had a severe reaction to a previous dose of the combination vaccine or any of its constituents is absolute contraindication to subsequent doses of the combination vaccine.
- •Patients who had pertussis, encephalopathy or other serious neurological abnormality in the newborn period
结局指标
主要结局
Adverse event
时间窗: up to 12 weeks after vaccination
次要结局
未报告次要终点
研究者
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