Post-marketing Safety of Elasomeran/Davesomeran and Andusomeran Vaccines in the United States
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15,196,685
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events of Special Interest (AESI)
研究概览
简要总结
The main objective of the study is to evaluate the safety of the elasomeran/davesomeran and andusomeran vaccines as used in routine clinical practice.
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
- •Cohort 1: Influenza vaccinated concurrent comparator
- •Eligible vaccine episodes must meet the following inclusion criteria within the protocol-specified time windows:
- •Non-missing sex: (start of available data, 1 day prior to index)
- •No receipt of elasomeran/davesomeran and andusomeran vaccine: (90 days prior to index, 1 day prior to index)
- •No receipt of influenza vaccine: (90 days prior to index, 1 day prior to index)
- •No receipt of any other COVID-19 vaccine: (90 days prior to index, index date)
- •Continuous enrollment in closed medical and pharmacy claims (365 days prior to index, index date)
- •Cohort 2: Medically attended COVID-19 concurrent comparator
- •Eligible vaccine and disease episodes must meet the following inclusion criteria within the specified time windows:
- •Non-missing sex: (start of available data, 1 day prior to index)
- •No receipt of elasomeran/davesomeran and andusomeran vaccine: (180 days prior to index, 1 day prior to index)
- •No evidence of medically attended COVID-19: (180 days prior to index, 1 day prior to index)
- •No receipt of any other COVID-19 vaccine: (180 days prior to index, index date)
- •Continuous enrollment in closed medical and pharmacy claims (365 days prior to index, index date)
排除标准
- •Vaccine and disease episodes with a prior AESI within the washout window will be excluded from the analytic cohort.
- •For the influenza vaccinated concurrent comparator cohort, individuals who receive an elasomeran/davesomeran and andusomeran vaccine and an influenza vaccine on the same day or within a minimum number of days will be excluded from the primary analysis.
- •Note: Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Cohort 1: Influenza Vaccinated Concurrent Comparator
Participants who receive an elasomeran/davesomeran or an andusomeran vaccine in routine clinical practice are compared to participants who receive an influenza vaccine to observe differences in the rate of adverse events of special interest during an etiologically relevant window.
干预措施: SPIKEVAX (Biological)
Cohort 2: Medically Attended COVID-19 Concurrent Comparator
Participants who receive an elasomeran/davesomeran or an andusomeran vaccine in routine clinical practice are compared to participants who diagnosed with COVID-19 to observe differences in in the rate of adverse events of special interest during an etiologically relevant window.
干预措施: SPIKEVAX (Biological)
结局指标
主要结局
Number of Participants With Adverse Events of Special Interest (AESI)
时间窗: Day 2 up to Day 60 after vaccination
次要结局
未报告次要终点