Post-Marketing Observational Study of Safety Following Vaccination With Flublok® Compared to Licensed IIV in Adults 18 Years of Age and Older
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 254,648
- 试验地点
- 1
- 主要终点
- Number of Participants with Serious adverse events (SAEs) and medically-attended adverse events (MAEs)
研究概览
简要总结
The primary objective of this study is to retrospectively characterize the safety of Flublok in adults 18 years of age and older, in comparison with egg-based trivalent or quadrivalent inactivated influenza vaccines (IIVs), using a methodological approach designed to query the database of electronic health records (EHR) maintained by Kaiser-Permanente, Northern California (KPNC), a large medical care organization (MCO).
详细描述
The primary analysis is a nonrandomized, observational retrospective cohort study. Data on adults 18 years of age and older who were enrolled in the KPNC database during the risk intervals after vaccination analyzed for this study who were vaccinated with Flublok or an IIV (either IIV3 or IIV4) will be identified for analysis. The rates of occurrence of specific MAEs of interest in pre-specified risk intervals following Flublok and IIV will be compared.
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
- 是
入选标准
- •Data from the EHR of all adult KPNC members 18 years of age and older, who received Flublok for active immunization against influenza as part of routine medical care within the KPNC system. The comparator cohort will include data from all adults in the same age group who received any IIV (trivalent or quadrivalent) during the period of Flublok administration.
排除标准
- •Healthcare providers are expected not to administer Flublok or IIV to individuals with known contraindication to either vaccine (see product package inserts). However, there will be no exclusions other than age and KPNC membership criteria at the time of vaccination.
结局指标
主要结局
Number of Participants with Serious adverse events (SAEs) and medically-attended adverse events (MAEs)
时间窗: Five months post-vaccination
Incidence of Serious and/or Medically-Attended Adverse events
次要结局
未报告次要终点