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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06029933
Recruitment Status : Recruiting
First Posted : September 8, 2023
Last Update Posted : September 8, 2023
Sponsor:
Collaborator:
Seqirus
Information provided by (Responsible Party):
Kaiser Permanente

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment
Influenza Community-acquired Pneumonia Cardiovascular Events Biological: Adjuvanted Quadrivalent Inactivated Influenza Vaccine (aIIV4) Biological: High-Dose Quadrivalent Inactivated Influenza Vaccine (HD-IIV4)

Study Design
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Study Type : Observational
Estimated Enrollment : 960000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 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
Actual Study Start Date : August 17, 2023
Estimated Primary Completion Date : May 2025
Estimated Study Completion Date : May 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot Vaccines

Groups and Cohorts
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Group/Cohort Intervention/treatment
Fluad Recipients
Kaiser Permanente Northern California members aged ≥65 years who receive Adjuvanted Quadrivalent Inactivated Influenza Vaccine (aIIV4)
 Biological: Adjuvanted Quadrivalent Inactivated Influenza Vaccine (aIIV4)
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.
Other Name: Fluad
Fluzone High-Dose Recipients
Kaiser Permanente Northern California members aged ≥65 years who receive High-Dose Quadrivalent Inactivated Influenza Vaccine (HD-IIV4)
 Biological: High-Dose Quadrivalent Inactivated Influenza Vaccine (HD-IIV4)
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.
Other Name: Fluzone High-Dose


Outcome Measures
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Primary Outcome Measures :
  1. 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 or May 2025) ]
    KPNC members ≥65 years who receive Fluad or Fluzone High-Dose will be retrospectively assessed for the presence of PCR-confirmed influenza. This outcome will be assessed in single-season analyses (2023/24 and 2024/25 separately) and a pooled 2-seasons analysis (2023/24 and 2024/25 combined).


Secondary Outcome Measures :
  1. Emergency department visit or hospitalization for 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 or May 2025) ]
    KPNC members ≥65 years who receive Fluad or Fluzone High-Dose will be retrospectively assessed for an emergency department visit or hospitalization for PCR-confirmed influenza. This outcome will be assessed in single-season analyses (2023/24 and 2024/25 separately) and a pooled 2-seasons analysis (2023/24 and 2024/25 combined).

  2. Hospitalization for 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 or May 2025) ]
    KPNC members ≥65 years who receive Fluad or Fluzone High-Dose will be retrospectively assessed for hospitalization for PCR-confirmed influenza. This outcome will be assessed in a pooled 2-seasons analysis (2023/24 and 2024/25 combined).

  3. Hospitalization for all-cause community-acquired pneumonia [ Time Frame: ≥14 days after vaccination until date of outcome, death, loss-to-follow-up, or end of each season (estimated May 2024 or May 2025) ]
    KPNC members ≥65 years who receive Fluad or Fluzone High-Dose will be retrospectively assessed for hospitalization for all-cause community-acquired pneumonia. This outcome will be assessed in single-season analyses (2023/24 and 2024/25 separately) and a pooled 2-seasons analysis (2023/24 and 2024/25 combined).


Other Outcome Measures:
  1. Hospitalization for cardiovascular events [ Time Frame: ≥14 days after vaccination until date of outcome, death, loss-to-follow-up, or end of each season (estimated May 2024 or May 2025) ]
    KPNC members ≥65 years who receive Fluad or Fluzone High-Dose will be retrospectively assessed for hospitalization for cardiovascular events. This outcome will be assessed in single-season analyses (2023/24 and 2024/25 separately) and a pooled 2-seasons analysis (2023/24 and 2024/25 combined).

  2. PCR-confirmed influenza in subgroups with comorbidities [ Time Frame: ≥14 days after vaccination until date of outcome, death, loss-to-follow-up, or end of each season (estimated May 2024 or May 2025) ]
    KPNC members ≥65 years with comorbidities (e.g., cardiovascular and respiratory conditions, diabetes, obesity) who receive Fluad or Fluzone High-Dose will be retrospectively assessed for hospitalization for PCR-confirmed influenza. This outcome will be assessed in a pooled 2-seasons analysis (2023/24 and 2024/25 combined).


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This study includes KPNC adults ≥65 years who receive Fluad or Fluzone High-Dose influenza vaccine as part of routine clinical care during the 2023/24 and/or 2024/25 influenza seasons.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06029933


Contacts
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Contact: Amber H. Hyman, PhD, MPH 510-267-7571 Amber.Hyman@kp.org

Locations
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United States, California
Kaiser Permanente Northern California (entire region) Recruiting
Oakland, California, United States, 94612
Contact: Amber H. Hyman, PhD, MPH    510-267-7517    Amber.Hyman@kp.org   
Principal Investigator: Nicola P. Klein, MD, PhD         
Sponsors and Collaborators
Kaiser Permanente
Seqirus
More Information
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Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT06029933    
Other Study ID Numbers: 2033496
First Posted: September 8, 2023    Key Record Dates
Last Update Posted: September 8, 2023
Last Verified: September 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs