NCT06690502已完成不适用
Safety Profile of Booster IndoVac COVID-19 Vaccination in Healthy Populations Aged 18 Years and Above
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
- 1,208
- 试验地点
- 28
- 主要终点
- Serious adverse event following IndoVac booster vaccination
研究概览
简要总结
This study is Post Authorization Safety Study (PASS) Phase IV of Booster IndoVac COVID-19 Vaccination
详细描述
This study is Post Authorization Safety Study (PASS) Phase IV, to assess any local and systemic reaction after immunization with IndoVac using retrospective cohort study trial design to assess safety profile following IndoVac booster vaccine in healthy populations aged 18 years and above.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinically healthy subjects aged 18 years and above
- •Subjects have been injected with IndoVac booster.
- •Minimum 6-month interval from primary or booster COVID-19 vaccination.
- •Subjects have been informed properly regarding the study and signed the informed consent form.
排除标准
- •Subjects concomitantly enrolled or scheduled to be enrolled in another study when the subjects got IndoVac booster vaccination.
- •Subject's telephone number is invalid or cannot be contacted.
结局指标
主要结局
Serious adverse event following IndoVac booster vaccination
时间窗: until 30 minutes after each dose
Any serious adverse event occurring from inclusion until 30 minutes after IndoVac booster vaccination
次要结局
- 0-7 Days Reactions(Within 0-7 Days after each dose)
- 8-28 Days Reactions(Within 8-28 Days after each dose)
- 28 Days Reactions(28 Days after each dose)
研究者
研究点 (28)
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