Fluad vs. Fluzone High-Dose Vaccine Effectiveness Among Adults ≥65 Years

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorKaiser Permanente

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Adjuvanted Quadrivalent Inactivated Influenza Vaccine (aIIV4)
  • High-Dose Quadrivalent Inactivated Influenza Vaccine (HD-IIV4)

Treatment groups

1,500,000 Participants
are divided into 2 treatment groups

Sponsors and collaborators