NCT02983656已完成不适用
Analysis on AEFI Surveillance Data for Live Attenuated Varicella Vaccine
Zhejiang Provincial Center for Disease Control and Prevention0 个研究点目标入组 394 人开始时间: 2016年11月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 394
- 主要终点
- incidence of adverse reactions
研究概览
简要总结
The purpose of this study is to observe the occurrence of adverse events of live attenuated varicella vaccine.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 1 Year 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The registered permanent residence or resident place are local (reside more than 3 months);
- •Participant preventive inoculation of varicella vaccine in 2014-2015;
- •Adverse reactions occurred and should be reported in the AEFI monitoring system.
排除标准
- •Subjects with a known allergy to any ingredient of the vaccine, and with any allergy history to any vaccine;
- •Subjects with any acute diseases, severe chronic diseases, acute bout of chronic diseases, and catching cold and fever;
- •Subjects with uncontrolled seizures and other progressive neurological diseases, with a history of Guillain-Barré syndrome.
结局指标
主要结局
incidence of adverse reactions
时间窗: 1 year after the first and second doses
次要结局
未报告次要终点
研究者
Qian Li
Deputy chief physician
Zhejiang Provincial Center for Disease Control and Prevention
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