NCT03383653已完成不适用
Safety Profile Following Td Vaccination in Indonesian Pregnant Woman
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
- 200
- 试验地点
- 1
- 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 Td immunization in pregnant woman
详细描述
Any local and systemic reaction after Td immunization in pregnant woman (as a routine immunization program)
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
- 18 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy Pregnant Woman aged 18-39 years old
- •27-36 weeks of pregnancy
- •Subject have been informed properly regarding the study and signed the informed consent form
- •Subject will commit to comply with the instructions of the investigator and the schedule of the trial
排除标准
- •Given simultaneously with other vaccines or with the interval less than 1 month with other vaccination
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 serious adverse events within 28 days after injection(28 days)
- Percentage of local and systemic events occurring from 72 hours up to 28 days following injection.(72 hours - 28 days)
- Percentage of local and systemic events occurring within 72 hours after each injection(72 hours)
研究者
研究点 (1)
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