Examining Vaccine Effectiveness (VE) of Flublok Relative to Standard Dose Inactivated Influenza Vaccine Among Kaiser Permanente Northern California Members Aged 18-64 Years
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,776,278
- 试验地点
- 1
- 主要终点
- Number of Adults 50-64 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza Tests
研究概览
简要总结
The overall objective of this study is to describe the effectiveness of Flublok Quadrivalent vaccine compared to standard dose inactivated influenza vaccine (SD-IIV) in adults 18 through 64 years of age. During this study, Flublok Quadrivalent or SD-IIV will be administered according to the guidelines in the Prescribing Information materials and only to persons for whom it is indicated. The 2018-2019, 2019-2020, and 2020-2021 formulations of recombinant influenza vaccine (Flublok Quadrivalent vaccine) and SD-IIV will be evaluated for outcomes including all polymerase chain reaction (PCR)-confirmed influenza, PCR-confirmed hospitalized influenza, hospitalized community-acquired pneumonia and cardio-respiratory events.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between the ages of ≥18 and <65 years at the time of influenza vaccination
- •Receive either Flublok Quadrivalent vaccine or standard dose inactivated influenza vaccine at a Kaiser Permanente Northern California facility during the study period from August 2018 through April 2020
排除标准
- •Children <18 years old
- •Adults ≥65 years old
研究组 & 干预措施
Flublok Recipients
Kaiser Permanente Northern California members aged 18-64 years who receive Flublok Quadrivalent vaccine.
干预措施: Flublok Quadrivalent (Biological)
SD-IIV Recipients
Kaiser Permanente Northern California members aged 18-64 years who receive standard dose inactivated influenza vaccine (SD-IIV).
干预措施: Standard Dose Inactivated Influenza Vaccine (SD-IIV) (Biological)
结局指标
主要结局
Number of Adults 50-64 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza Tests
时间窗: Up to 8 months
Patients who receive either Flublok or SD-IIV will be retroactively assessed for whether they had a PCR-confirmed positive influenza test (≥14 days after vaccination) as recorded in their electronic medical record by the end of the influenza season (April 30).
次要结局
- Number of Adults 50-64 Years Old Hospitalized With PCR-confirmed Influenza(Up to 8 months)
- Number of Adults 50-64 Years Old Hospitalized With Community-acquired Pneumonia(Up to 8 months)
- Number of Adults 50-64 Years Old Hospitalized With Cardio-respiratory Events(Up to 8 months)
- Number of Adults 50-64 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza A Tests(Up to 8 months)
- Number of Adults 50-64 Years Old With Polymerase-chain Reaction (PCR) Confirmed Influenza B Tests(Up to 8 months)