NCT02093286已完成不适用
Phase IV, Study of Safety Profile Following Pentabio Vaccination in Indonesian Infants
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- PT Bio Farma
- 入组人数
- 4,000
- 试验地点
- 4
- 主要终点
- Any serious adverse event occurring from inclusion until 30 minutes after the injection
研究概览
简要总结
To assess any serious systemic reaction within 30 minutes after Pentabio immunization
详细描述
Any local and systemic reaction after Pentabio immunization
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Months 至 11 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Immunization with Pentabio vaccine
- •Parents already understood the consequences to be involved in this study and having signed the informed consent form
- •Parents agree and willing to fill in the Diary Card, to record all the reactions after immunization
排除标准
- •Given simultaneously with other vaccines or with the interval less than 1 month with other vaccination except OPV/IPV.
结局指标
主要结局
Any serious adverse event occurring from inclusion until 30 minutes after the injection
时间窗: 30 minutes
local and systemic reaction
次要结局
- Percentage of local and systemic events occurring within 72 hours after each injection(72 hours)
- Percentage of local and systemic events occurring from 72 hours up to 28 days following injection.(25 days)
- Percentage of serious adverse events within 28 days after injection(28 days)
研究者
研究点 (4)
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