Safety Profile Following Moderna COVID-19 Primary Vaccine in Healthy Adults Aged ≥ 18 Years in Indonesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- PT Bio Farma
- 入组人数
- 1,284
- 试验地点
- 18
- 主要终点
- Local Reactions Following Moderna COVID-19 Vaccine
研究概览
简要总结
This study is Post Authorization Safety Study (PASS) Phase IV of Moderna COVID-19 Primary Vaccine
详细描述
This study is Post Authorization Safety Study (PASS) Phase IV, to assess any local and systemic reaction after immunization with Moderna COVID-19 vaccine using retrospective cohort study trial design to assess safety profile following Moderna COVID-19 primary vaccine in healthy adults aged ≥ 18 years in Indonesia.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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 adults aged ≥ 18 years.
- •Subjects have been informed properly regarding the study and accepted to be enrolled in this study.
排除标准
- •Subjects concomitantly enrolled or scheduled to be enrolled in another trial at the time of receiving the Moderna COVID-19 vaccine.
结局指标
主要结局
Local Reactions Following Moderna COVID-19 Vaccine
时间窗: 28 Days after each dose
Percentage of subject with local reactions following immunization with Moderna COVID-19 vaccine.
Systemic Reactions Following Moderna COVID-19 Vaccine
时间窗: 28 Days after each dose
Percentage of subject with systemic reactions following immunization with Moderna COVID-19
次要结局
- Immediate Reactions(30 minutes after each dose)
- 1-3 Days Reactions(1-3 minutes after each dose)
- 4-7 Days Reactions(4-7 Days after each dose)
- 8-28 Days Reactions(8-28 Days after each dose)
- Serious Reactions(28 Days after each dose)