NCT05037227已完成不适用
Safety Profile Following Inactivated COVID-19 Vaccine in Healthy Adults Aged >18 Years in Indonesia
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
- 1,100
- 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
The aim of this study is evaluating safety profile of COVID-19 Vaccine in healthy adults aged >18 years in Indonesia.
详细描述
To assess any serious systemic reaction within 30 minutes after COVID-19 vaccine immunization.
To assess systemic reaction after COVID-19 Vaccine immunization. To assess local reaction after COVID-19 Vaccine immunization. To assess any serious adverse event after COVID-19 Vaccine immunization.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinically healthy adults aged > 18 years.
- •Subjects have been informed properly regarding the study and signed the informed consent form.
- •Subjects will commit to comply with the instructions of the investigator and the schedule of the trial.
排除标准
- •Subjects concomitantly enrolled or scheduled to be enrolled in another trial.
- •Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with thermometer).
- •Women who are lactating, pregnant or planning to become pregnant during the study period.
- •History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
- •Subjects who have any history of confirmed or suspected immunosuppressive or immunodeficient state, or received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long-term corticosteroid therapy (> 2 weeks)).
- •Subjects receive any vaccination within 1 month before and after IP immunization.
- •Subjects plan to move from the study area before the end of study period.
结局指标
主要结局
Any serious adverse event occurring from inclusion until 30 minutes after the injection
时间窗: Within 30 minutes after vaccination
Number and percentage of subjects with serious systemic reactions 30 minutes after immunization.
次要结局
- Local reaction and systemic events occurring within 30 minutes after each immunization.(Within 30 minutes after vaccination)
- Local reaction and systemic events occurring within 28 days after immunization(28 days)
- Any serious adverse event during observation period.(28 days)
研究者
研究点 (1)
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