xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06029933</url>
    </required_header>
    <id_info>
      <org_study_id>2033496</org_study_id>
      <nct_id>NCT06029933</nct_id>
    </id_info>
    <brief_title>Fluad vs. Fluzone High-Dose Vaccine Effectiveness Among Adults ≥65 Years</brief_title>
    <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</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Kaiser Permanente</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Seqirus</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Kaiser Permanente</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study will evaluate the relative vaccine effectiveness of quadrivalent adjuvanted&#xD;
        inactivated influenza vaccine (aIIV4) versus quadrivalent high-dose inactivated influenza&#xD;
        vaccine (HD-IIV4) in preventing polymerase chain reaction (PCR)-confirmed influenza and&#xD;
        influenza-related outcomes in adults ≥65 years of age during the 2023/24 and 2024/25&#xD;
        influenza seasons. The study is an observational study conducted at Kaiser Permanente&#xD;
        Northern California (KPNC), an integrated health care system in the United States.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 17, 2023</start_date>
    <completion_date type="Anticipated">May 2026</completion_date>
    <primary_completion_date type="Anticipated">May 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>PCR-confirmed influenza</measure>
      <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)</time_frame>
      <description>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).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Emergency department visit or hospitalization for PCR-confirmed influenza</measure>
      <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)</time_frame>
      <description>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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hospitalization for PCR-confirmed influenza</measure>
      <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)</time_frame>
      <description>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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hospitalization for all-cause community-acquired pneumonia</measure>
      <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)</time_frame>
      <description>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).</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Hospitalization for cardiovascular events</measure>
      <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)</time_frame>
      <description>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).</description>
    </other_outcome>
    <other_outcome>
      <measure>PCR-confirmed influenza in subgroups with comorbidities</measure>
      <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)</time_frame>
      <description>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).</description>
    </other_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">960000</enrollment>
    <condition>Influenza</condition>
    <condition>Community-acquired Pneumonia</condition>
    <condition>Cardiovascular Events</condition>
    <arm_group>
      <arm_group_label>Fluad Recipients</arm_group_label>
      <description>Kaiser Permanente Northern California members aged ≥65 years who receive Adjuvanted Quadrivalent Inactivated Influenza Vaccine (aIIV4)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Fluzone High-Dose Recipients</arm_group_label>
      <description>Kaiser Permanente Northern California members aged ≥65 years who receive High-Dose Quadrivalent Inactivated Influenza Vaccine (HD-IIV4)</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Adjuvanted Quadrivalent Inactivated Influenza Vaccine (aIIV4)</intervention_name>
      <description>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.</description>
      <arm_group_label>Fluad Recipients</arm_group_label>
      <other_name>Fluad</other_name>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>High-Dose Quadrivalent Inactivated Influenza Vaccine (HD-IIV4)</intervention_name>
      <description>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.</description>
      <arm_group_label>Fluzone High-Dose Recipients</arm_group_label>
      <other_name>Fluzone High-Dose</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          This study includes KPNC adults ≥65 years who receive Fluad or Fluzone High-Dose influenza&#xD;
          vaccine as part of routine clinical care during the 2023/24 and/or 2024/25 influenza&#xD;
          seasons.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥65 years at the time of influenza vaccination&#xD;
  &#xD;
            -  KPNC member at the time of vaccination&#xD;
  &#xD;
            -  Receive either aIIV4 or HD-IIV4 at a KPNC facility during the 2023/24 and/or 2024/25&#xD;
               influenza seasons&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age &lt;65 years at the time of influenza vaccination&#xD;
  &#xD;
            -  Received either aIIV4 or HD-IIV4 in the inpatient setting&#xD;
  &#xD;
            -  Receive more than one influenza vaccination during a single season period (i.e.,&#xD;
               2023/24 or 2024/25 influenza seasons)&#xD;
  &#xD;
            -  Receive an influenza vaccination outside of KPNC&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Amber H. Hyman, PhD, MPH</last_name>
      <phone>510-267-7571</phone>
      <email>Amber.Hyman@kp.org</email>
    </overall_contact>
    <location>
      <facility>
        <name>Kaiser Permanente Northern California (entire region)</name>
        <address>
          <city>Oakland</city>
          <state>California</state>
          <zip>94612</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Amber H. Hyman, PhD, MPH</last_name>
        <phone>510-267-7517</phone>
        <email>Amber.Hyman@kp.org</email>
      </contact>
      <investigator>
        <last_name>Nicola P. Klein, MD, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Influenza, Human</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Vaccines</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06029933
  org study id: 2033496
  nct id: NCT06029933
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  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.
  observational model: Cohort
  time perspective: Retrospective
  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 or May 2025)
  description: 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).
  measure: 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)
  description: 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).
  measure: 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)
  description: 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).
  measure: 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)
  description: 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).
  measure: 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)
  description: 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).
  measure: 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)
  description: 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).
  arm group label: Fluad Recipients
  description: Kaiser Permanente Northern California members aged ≥65 years who receive Adjuvanted Quadrivalent Inactivated Influenza Vaccine (aIIV4)
  arm group label: Fluzone High-Dose Recipients
  description: Kaiser Permanente Northern California members aged ≥65 years who receive High-Dose Quadrivalent Inactivated Influenza Vaccine (HD-IIV4)
  intervention type: Biological
  intervention name: Adjuvanted Quadrivalent Inactivated Influenza Vaccine (aIIV4)
  description: 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.
  arm group label: Fluad Recipients
  other name: Fluad
  intervention type: Biological
  intervention name: High-Dose Quadrivalent Inactivated Influenza Vaccine (HD-IIV4)
  description: 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.
  arm group label: Fluzone High-Dose Recipients
  other name: Fluzone High-Dose
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Amber H. Hyman, PhD, MPH
  phone: 510-267-7571
  email: Amber.Hyman@kp.org
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Influenza, Human
  mesh term: Vaccines