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

Kaiser Permanente logo

Kaiser Permanente

Status

Enrolling

Conditions

Influenza
Community-acquired Pneumonia
Cardiovascular Events

Treatments

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

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT06029933
2033496

Details and patient eligibility

About

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.

Enrollment

960,000 estimated patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

960,000 participants in 2 patient groups

Fluad Recipients
Description:
Kaiser Permanente Northern California members aged ≥65 years who receive Adjuvanted Quadrivalent Inactivated Influenza Vaccine (aIIV4)
Treatment:
Biological: Adjuvanted Quadrivalent Inactivated Influenza Vaccine (aIIV4)
Fluzone High-Dose Recipients
Description:
Kaiser Permanente Northern California members aged ≥65 years who receive High-Dose Quadrivalent Inactivated Influenza Vaccine (HD-IIV4)
Treatment:
Biological: High-Dose Quadrivalent Inactivated Influenza Vaccine (HD-IIV4)

Trial contacts and locations

1

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Central trial contact

Amber H. Hyman, PhD, MPH

Data sourced from clinicaltrials.gov

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