NCT03541694已完成不适用
Passive Enhanced Safety Surveillance of the Live Attenuated Yellow Fever Virus Vaccine Stamaril® in Korea
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 622
- 试验地点
- 1
- 主要终点
- Number of participants reporting suspected related adverse events
研究概览
简要总结
This is a passive enhance safety surveillance (ESS) of Stamaril® vaccine in Korea. The objective is to collect suspected related adverse events following vaccination with Stamaril® in routine practice.
详细描述
This ESS replaces the routing post-marketing surveillance required after product approval in Korea.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of participants reporting suspected related adverse events
时间窗: Within 30 days after vaccination
Spontaneous reporting of suspected related adverse events
次要结局
- Number of participants reporting suspected serious related adverse events(Within 30 days after vaccination)
研究者
研究点 (1)
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