NCT04958954已完成不适用
Post-Marketing Safety of SARS-CoV-2 mRNA-1273 Vaccine in the US: Active Surveillance, Signal Refinement and Self-Controlled Risk Interval (SCRI) Signal Evaluation in HealthVerity
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50,000,000
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events of Special Interests (AESIs)
研究概览
简要总结
The goal of this study is to add to the ongoing active and passive safety signal detection through signal refinement and, if needed, evaluation of potential safety signals related to taking the SARS-CoV-2 mRNA-1273 vaccine.
详细描述
This retrospective observational cohort study will use secondary, de-identified individual-level medical and pharmacy claims data provided by HealthVerity.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Included in a health plan covered by HealthVerity database
- •Covered by a health plan during at least 1 period of interest (pre-COVID-19, active-COVID-19, and post-EUA periods), but not necessarily the full period.
- •Demonstrate an AESI specified clean period of continuous baseline enrollment or activity before the period of interest (pre-COVID-19, active-COVID-19, and post-EUA periods) during which the participant is covered.
排除标准
- 未提供
结局指标
主要结局
Number of Participants With Adverse Events of Special Interests (AESIs)
时间窗: Index date (that is, first day of health plan eligibility within the applicable time period where all study entry criteria are met) through end of data availability or earliest event (maximum of 751 days depending on duration of capture in the database)
次要结局
未报告次要终点
研究者
研究点 (1)
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