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临床试验/NCT05894590
NCT05894590已完成不适用

Cohort Survey on Non-Acute Safety in Persons With Underlying Diseases Who Are Considered to Be at High Risk of Severe COVID-19 by Using Vaccination Information

ModernaTX, Inc.1 个研究点 分布在 1 个国家目标入组 13,680 人开始时间: 2022年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
13,680
试验地点
1
主要终点
Number of Participants With Serious Events Associated With all-Cause Hospitalizations

研究概览

简要总结

The goal of this study is to assess serious adverse events associated with hospitalizations in the non-acute phase after vaccination with the mRNA-1273 vaccine in persons with underlying diseases who are considered to have a high risk of severe exacerbation of COVID-19.

详细描述

Data collected from the JMDC Claims database from May 2020 to October 2022.

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

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.

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 Serious Events Associated With all-Cause Hospitalizations

时间窗: Up to 1 year post vaccination

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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