NCT06029933RecruitingAccepts Healthy Volunteers

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

Kaiser Permanente

Start Date

8/17/2023

Completion Date

5/1/2028

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, 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

Age Range: 65 years to No maximum

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

Interventions

BIOLOGICAL

Adjuvanted Quadrivalent Inactivated Influenza Vaccine (aIIV4)

BIOLOGICAL

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

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Conditions

InfluenzaCommunity-acquired PneumoniaCardiovascular Events

Locations

Kaiser Permanente Northern California (entire region)

Oakland, California 94612

United States