NCT05894499已完成不适用
Cohort Survey on Shock and Anaphylaxis in Persons With Underlying Diseases Considered to Be at High Risk of Severe COVID-19 by Using Vaccination Information
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13,309
- 试验地点
- 1
- 主要终点
- Number of Participants With Hypersensitivity Reactions Including Shock and Anaphylaxis After Either Dose 1 and Dose 2
研究概览
简要总结
The goal of this study is to confirm the onset status of hypersensitivity reactions including shock and anaphylaxis observed after vaccination with this drug in persons with underlying diseases who are considered to have a high risk of severe exacerbation of COVID-19 and explore risk factors.
详细描述
Data collected from the JDMC Claims Database between May 2021 to November 2021.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants registered to receive the mRNA-1273 vaccine in the Pep Up vaccination history Database
- •Participants who have a history of vaccination with the mRNA-1273 vaccine in the Pep-Up vaccination history Database and the observation start date is at least 6 months prior to vaccination with the mRNA-1273 vaccine and have underlying diseases. Data period for confirmation of presence/absence of underlying disease is May 2021 to November 2021.
排除标准
- •Underlying diseases that were determined undetectable by the pre-screening of JMDC
- •Participants who did not consent to the questionnaire.
结局指标
主要结局
Number of Participants With Hypersensitivity Reactions Including Shock and Anaphylaxis After Either Dose 1 and Dose 2
时间窗: Up to 2 days post vaccination after either the first or second vaccination
次要结局
- Number of Participants With Hypersensitivity Reactions Including Shock and Anaphylaxis After Dose 2(Up to 2 days post vaccination)
- Number of Participants With Hypersensitivity Reactions Including Shock and Anaphylaxis After Dose 1(Up to 2 days post vaccination)
研究者
研究点 (1)
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