Relative Vaccine Effectiveness of Adjuvanted Inactivated Influenza Vaccine (aIIV) vs High-Dose Inactivated Influenza Vaccine (HD-IIV) for Prevention of Lab-Confirmed Influenza Among Adults ≥65 Years of Age in the United States
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,500,000
- 试验地点
- 1
- 主要终点
- PCR-confirmed influenza
研究概览
简要总结
This study will evaluate the relative vaccine effectiveness of quadrivalent adjuvanted inactivated influenza vaccine (aIIV4) versus quadrivalent high-dose inactivated influenza vaccine (HD-IIV4) in preventing polymerase chain reaction (PCR)-confirmed influenza and influenza-related outcomes in adults ≥65 years of age during the 2023/24, 2024/25, and 2026/27 influenza seasons. The study is an observational study conducted at Kaiser Permanente Northern California (KPNC), an integrated health care system in the United States.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥65 years at the time of influenza vaccination
- •KPNC member at the time of vaccination
- •Receive either aIIV4 or HD-IIV4 at a KPNC facility during the 2023/24 and/or 2024/25 influenza seasons
排除标准
- •Age <65 years at the time of influenza vaccination
- •Received either aIIV4 or HD-IIV4 in the inpatient setting
- •Receive more than one influenza vaccination during a single season period (i.e., 2023/24 or 2024/25 influenza seasons)
- •Receive an influenza vaccination outside of KPNC
研究组 & 干预措施
Fluzone High-Dose Recipients
Kaiser Permanente Northern California members aged ≥65 years who receive High-Dose Quadrivalent Inactivated Influenza Vaccine (HD-IIV4)
干预措施: High-Dose Quadrivalent Inactivated Influenza Vaccine (HD-IIV4) (Biological)
Fluad Recipients
Kaiser Permanente Northern California members aged ≥65 years who receive Adjuvanted Quadrivalent Inactivated Influenza Vaccine (aIIV4)
干预措施: Adjuvanted Quadrivalent Inactivated Influenza Vaccine (aIIV4) (Biological)
结局指标
主要结局
PCR-confirmed influenza
时间窗: ≥14 days after vaccination until date of outcome, death, loss-to-follow-up, or end of each season (estimated May 2024, May 2025, or May 2027)
KPNC members ≥65 years who receive Fluad or Fluzone High-Dose will be retrospectively assessed for the presence of PCR-confirmed influenza. This outcome will be assessed in single-season analyses (2023/24, 2024/25, and 2026/27 separately) and a pooled analysis across all seasons.
次要结局
- Emergency department visit or hospitalization for PCR-confirmed influenza(≥14 days after vaccination until date of outcome, death, loss-to-follow-up, or end of each season (estimated May 2024, May 2025, or May 2027))
- Hospitalization for PCR-confirmed influenza(≥14 days after vaccination until date of outcome, death, loss-to-follow-up, or end of each season (estimated May 2024, May 2025, or May 2027))
- Hospitalization for all-cause community-acquired pneumonia(≥14 days after vaccination until date of outcome, death, loss-to-follow-up, or end of each season (estimated May 2024, May 2025, or May 2027))