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

Part of paid clinical trials in Oakland, California.

Sponsor
Kaiser Permanente
Study ID
NCT06029933
Status
Recruiting
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Conditions

  • Cardiovascular Events
  • Community-acquired Pneumonia
  • Influenza

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Adjuvanted Quadrivalent Inactivated Influenza Vaccine (aIIV4) — BIOLOGICAL
    Fluad Quadrivalent vaccine is an inactivated influenza vaccine formulated to contain 60 mcg of hemagglutinin (HA) total, with 15 mcg from each of the four recommended influenza strains and the MF59 adjuvant in single-dose prefilled 0.5 mL syringes. Kaiser Permanente Northern California members ≥65 years may receive Fluad as part of routine clinical care during the influenza season.
  • High-Dose Quadrivalent Inactivated Influenza Vaccine (HD-IIV4) — BIOLOGICAL
    Fluzone High-Dose Quadrivalent vaccine is an inactivated split virion influenza vaccine formulated to contain 240 mcg of HA total, with 60 mcg from each of the four recommended influenza strains in single-dose prefilled 0.7 mL syringes. Kaiser Permanente Northern California members ≥65 years may receive Fluzone High-Dose as part of routine clinical care during the influenza season.

Study Details

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.

Key Dates

First listed
Sep 8, 2023
Start date
Aug 17, 2023
Status verified
Jul 2026
Primary completion
May 31, 2027
Completion
May 31, 2028

Study Design

Enrollment
1,500,000 participants (estimated)

Arms

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

Primary Outcome Measure

PCR-confirmed influenza [ Time Frame: ≥14 days after vaccination until date of outcome, death, loss-to-follow-up, or end of each season (estimated May 2024, May 2025, or May 2027) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Kaiser Permanente Northern California (entire region)OaklandCalifornia94612
Amber H. Hyman, PhD, MPH
[email protected]
(510) 267-7517
Nicola P. Klein, MD, PhD (PRINCIPAL_INVESTIGATOR)

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Kaiser Permanente Northern California (entire region)· Oakland, CA

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