临床试验/NCT05894525

NCT05894525已完成不适用

Cohort Survey on Acute Phase Safety in Persons With Underlying Diseases 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 8,844 人开始时间: 2022年11月15日最近更新: 2024年3月15日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: ModernaTX, Inc.
入组人数: 8,844
试验地点: 1
主要终点: Number of Participants With Solicited Acute Adverse Events

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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

详细描述

Data collected from the JDMC Claims Database between August 2020 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 have underlying diseases. Data period for confirmation of presence/absence of underlying disease is August 2020 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 Solicited Acute Adverse Events

时间窗: Up to 8 days post vaccination

次要结局

未报告次要终点

研究者

发起方

ModernaTX, Inc.

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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