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Fluad vs. Fluzone High-Dose Vaccine Effectiveness Among Adults ≥65 Years | Clinical Trials | Clareo Health

RECRUITING

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

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

NCT06029933•Kaiser Permanente

View on ClinicalTrials.gov

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.

Eligibility

Age

65 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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

Locations (1)

Kaiser Permanente Northern California (entire region)

Oakland, California, United States

Key Dates

Start Date

August 17, 2023

Primary Completion Date

May 1, 2025

Completion Date

May 1, 2026

Last Updated

September 8, 2023

Enrollment

960,000

ESTIMATED participants

Conditions

InfluenzaCommunity-acquired PneumoniaCardiovascular Events

Interventions

Adjuvanted Quadrivalent Inactivated Influenza Vaccine (aIIV4)

BIOLOGICAL

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

BIOLOGICAL

Contacts

Amber H. Hyman, PhD, MPH

CONTACT

510-267-7571 Amber.Hyman@kp.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 8, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Phase 1/2 Study of a Plant-Based Seasonal Recombinant Trivalent VLP Influenza Vaccine

A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts

Dime La VerDAD: Verify, Debunk, and Disseminate

Clinical Outcomes and Pharmacotherapy Effectiveness in the VA Health Care System (COPE-VA)

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Administration of the Nasal Influenza Vaccine to Children in Daycare or at a Healthcare Facility