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

Last updated: September 1, 2023
Sponsor: Kaiser Permanente
Overall Status: Active - Recruiting

Phase

N/A

Condition

Influenza

Pneumonia (Pediatric)

Pneumonia

Treatment

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

Adjuvanted Quadrivalent Inactivated Influenza Vaccine (aIIV4)

Clinical Study ID

NCT06029933
2033496
  • Ages > 65
  • All Genders
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

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 2024/25influenza seasons

Exclusion

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

Study Design

Total Participants: 960000
Treatment Group(s): 2
Primary Treatment: High-Dose Quadrivalent Inactivated Influenza Vaccine (HD-IIV4)
Phase:
Study Start date:
August 17, 2023
Estimated Completion Date:
May 31, 2026

Connect with a study center

  • Kaiser Permanente Northern California (entire region)

    Oakland, California 94612
    United States

    Active - Recruiting

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