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NCT06029933 | RECRUITING | Influenza

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

Kaiser Permanente

Brief Summary:

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 and 2024/25 influenza seasons. The study is an observational study conducted at Kaiser Permanente Northern California (KPNC), an integrated health care system in the United States.

Condition or disease

Influenza

Community-acquired Pneumonia

Cardiovascular Events

Intervention/treatment

Adjuvanted Quadrivalent Inactivated Influenza Vaccine (aIIV4)

High-Dose Quadrivalent Inactivated Influenza Vaccine (HD-IIV4)

Study Type : OBSERVATIONAL
Estimated Enrollment : 960000 participants
Official Title : Relative Vaccine Effectiveness of Adjuvanted Quadrivalent Inactivated Influenza Vaccine vs High-Dose Quadrivalent Inactivated Influenza Vaccine Among Adults ≥65 Years for the 2023-24 and 2024-25 Seasons
Actual Study Start Date : 2023-08-17
Estimated Primary Completion Date : 2025-05
Estimated Study Completion Date : 2026-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • * 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
Exclusion Criteria
  • * 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
Fluad vs. Fluzone High-Dose Vaccine Effectiveness Among Adults ≥65 Years

Location Details

NCT06029933

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

Kaiser Permanente Northern California (entire region)

Oakland, California, United States, 94612