NCT05366322已完成不适用
Real-world Comparative Effectiveness of the mRNA-1273 Vaccine vs. BNT162b2 Vaccine Among Immunocompromised Adults in the United States
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124,879
- 试验地点
- 1
- 主要终点
- Number of Participants with Medically Attended Breakthrough COVID-19 Diagnosis
研究概览
简要总结
The goal of this study is to compare real-world effectiveness of the mRNA-1273 vaccine versus the BNT162b2 vaccine on medically attended COVID-19 and COVID-19 hospitalizations among fully vaccinated immunocompromise participants.
详细描述
This observational retrospective comparative effectiveness cohort study will use the HealthVerity aggregated medical and pharmacy claims database. HealthVerity data elements include provider-submitted claims, adjudicated insurance claims, and pharmacy billing manager claims submissions. Hospitalizations are included in the data at a summary level.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fully vaccinated with a currently US authorized COVID-19 vaccine:
- •2 doses of mRNA-1273 (minimum 14 days between doses)
- •2 doses of BNT1262b2 (minimum 14 days between doses)
- •Continuous enrollment in medical & pharmacy plan for at least 365 days prior to index/Cohort entry date (CED)
- •Identified as immunocompromised via at least 1 of the following criteria at index/CED
- •Evidence of blood or stem cell transplant in 2 years prior to index/CED
- •Any history of organ transplant and taking immunosuppressive therapy within the 60 days prior to index/CED
- •Evidence of active cancer treatment in the 180 days prior to index/CED with an active cancer diagnosis in the 365 days prior to treatment
- •Any prior history of a primary immunodeficiency disorder (for example, for conditions such as DiGeorge syndrome and Wiskott-Aldrich syndrome)
- •Any history of an HIV diagnosis code prior to index/CED
- •A fill for an immunosuppressive therapy in the 60 days prior to index/CED
排除标准
- •Prior COVID-19 infection (any history prior to index/CED through day 13 post-completion of vaccine regimen) identified via the following diagnosis codes on an inpatient or outpatient claim:
- •U07.1: "COVID-19, virus identified"
- •J12.82: "Pneumonia due to COVID-19"
- •Z86.16: "Personal history of COVID-19"
- •The following diagnosis codes were utilized early in the pandemic. Exclusion will be applied March 1, 2020 through day 13 post-completion of vaccine regimen:
- •J12.89: "Other viral pneumonia"
- •J20.8: "Acute bronchitis due to other specified organisms"
- •J40: "Bronchitis, not specified as acute or chronic"
- •J22: "Unspecified acute lower respiratory infection"
- •J98.8: "Other specified respiratory disorders"
- •J80: "Acute respiratory distress syndrome"
- •Prior receipt of a heterologous COVID-19 vaccine (relative to the COVID-19 vaccine identified at index/CED) in the 365 days prior to index/CED through 13 days post-completion of vaccine regimen
- •Receipt of an additional dose of homologous COVID-19 vaccine between index/CED and 13 days post-completion of vaccine regimen
- •Missing or unknown gender on index/CED
结局指标
主要结局
Number of Participants with Medically Attended Breakthrough COVID-19 Diagnosis
时间窗: Index date (14-days post-receipt of 2nd dose of mRNA-1273 to BNT162b2) up to end of available data (12 October 2021 [up to 9 months])
Medically attended breakthrough COVID-19 diagnosis defined as a claim for COVID-19 in any setting (inpatient, outpatient, emergency room, urgent care, etc.).
次要结局
- Number of Participants with Breakthrough Hospitalization for COVID-19(Index date (14-days post-receipt of 2nd dose of mRNA-1273 to BNT162b2) up to end of available data (12 October 2021 [up to 9 months]))
研究者
研究点 (1)
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