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/NCT06015282</url>
    </required_header>
    <id_info>
      <org_study_id>V201_03</org_study_id>
      <nct_id>NCT06015282</nct_id>
    </id_info>
    <brief_title>The Celljuvant Study: A Phase 3 Immunogenicity and Safety Study of aQIVc Vaccine in Adults Aged 50 Years and Older</brief_title>
    <official_title>A Phase 3, Randomized, Observer-Blind, Controlled, Multicenter, Clinical Study to Evaluate Immunogenicity and Safety of a MF59-Adjuvanted Quadrivalent Subunit Cell-derived Influenza Vaccine (aQIVc) in Comparison With Quadrivalent Influenza Vaccines, in Adults Aged 50 Years and Older.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Seqirus</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Seqirus</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a Phase 3, randomized, parallel-group, comparator-controlled, observer-blind,&#xD;
        multicenter study of immunogenicity and safety in approximately 7700 male and female adults&#xD;
        aged 50 years and older (approximately equally split between two age groups: 50-64 years; 65&#xD;
        years and older), who are healthy or have stable comorbidities that increase their risk of&#xD;
        complications from influenza infection. Three lots of aQIVc will be evaluated for consistency&#xD;
        and pooled for the comparison with the 2 control vaccines.&#xD;
  &#xD;
        Subjects will be randomly assigned to receive 1 of 3 lots of aQIVc, QIV1, or QIV2 in a&#xD;
        1:1:1:2:2 ratio (for a 3:2:2 ratio for aQIVc, QIV1, and QIV2).&#xD;
  &#xD;
        The study will have a treatment period (Day 1 to Day 29) and a follow-up period (Day 30 up to&#xD;
        Day 181); a subset of 770 subjects will be followed up up to Day 365.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2, 2023</start_date>
    <completion_date type="Anticipated">October 28, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 19, 2024</primary_completion_date>
    <phase>Phase 3</phase>
    <study_type>Interventional</study_type>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Immunogenicity Endpoint: Humoral immune responses of 3 lots of aQIVc compared in pairs in terms of Day 29 GMT ratio between each pair among the 3 lots, from antibody titers measured via HI assay.</measure>
      <time_frame>Day 29</time_frame>
      <description>HI assay will be measured using cell-derived target viruses for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Immunogenicity Endpoint: Humoral immune responses of aQIVc in comparison with QIV1 and QIV2 vaccines in terms of Day 29 GMT and GMT ratio of antibodies measured via HI assay.</measure>
      <time_frame>Day 29</time_frame>
      <description>HI assay will be measured using cell-derived target viruses for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains.&#xD;
  Noninferiority of aQIVc versus comparator (QIV1 or QIV2) will be demonstrated if the lower limit (LL) of the 2-sided 97.5% CI for the Day 29 GMT ratio (aQIVc/comparator) is ≥0.67 for each of the 4 vaccine strains.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Immunogenicity Endpoint: Humoral immune responses of aQIVc in comparison with QIV1 and QIV2 vaccines in terms of Day 1 to Day 29 SCR and SCR difference, from antibody titers measured via HI assay.</measure>
      <time_frame>Day 1 and Day 29</time_frame>
      <description>HI assay will be measured using cell-derived target viruses for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains.&#xD;
  SCR is the percentage of subjects with seroconversion (defined as either a prevaccination [Day 1] titer &lt;1:10 and a postvaccination [Day 29] titer ≥1:40, or a prevaccination titer ≥1:10 and a ≥4-fold increase in postvaccination titer).&#xD;
  Noninferiority of aQIVc versus comparator (QIV1 or QIV2) will be demonstrated if the lower limit (LL) of the 2-sided 97.5% CI for the difference in SCR (aQIVc minus comparator) is ≥-10% for each of the 4 vaccine strains.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Immunogenicity Endpoint: Humoral immune responses of aQIVc in comparison with QIV1 and QIV2 vaccines in terms of Day 29 GMT and GMT ratio of antibodies measured via HI assay.</measure>
      <time_frame>Day 29</time_frame>
      <description>HI assay will be measured using cell-derived target viruses for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains.&#xD;
  Superiority of aQIVc versus comparator (QIV1 and QIV2) will be demonstrated if the LL of the 2-sided 97.5% CI for the inter-group GMT ratio (aQIVc/comparator) is &gt;1.0 for each of the 4 vaccine strains.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Immunogenicity Endpoints: For aQIVc, QIV1, and QIV2 vaccines, Day 29 GMT, Day 1 to Day 29 GMFI, Percentage of subjects with HI titer ≥1:40 at Day 29, Day 1 to Day 29 SCR, SCR differences and GMT ratio of antibodies measured via HI assay.</measure>
      <time_frame>Day 1 and Day 29</time_frame>
      <description>HI assay will be measured using cell-derived target viruses for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains, overall and by age subgroup.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Immunogenicity Endpoints: For aQIVc and QIV1 vaccines, Day 29 GMT, Day 1 to Day 29 GMFI, Percentage of subjects with HI titer ≥1:40 at Day 29, Day 1 to Day 29 SCR, SCR differences, and GMT ratio of antibodies measured via HI assay.</measure>
      <time_frame>Day 1 and Day 29</time_frame>
      <description>HI assay will be measured using egg-derived target viruses for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains in the HI-egg subset of 2750 subjects, overall and by age subgroup.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Immunogenicity Endpoints: For aQIVc, QIV1 and QIV2 vaccines, GMT, GMFI, Percentage of subjects with HI titer ≥1:40, SCR, SCR differences, and GMT ratio of antibodies measured via HI assay.</measure>
      <time_frame>Day 1 up to Day 365</time_frame>
      <description>HI assay will be measured using cell-derived target viruses for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains in the long-term subset of 770 subjects, overall and by age subgroup.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Immunogenicity Endpoints: For aQIVc, QIV1 and QIV2 vaccines, GMT, GMFI, SCR, SCR difference, and GMT ratio of antibodies measured via MN assay.</measure>
      <time_frame>Day 1 up to Day 365</time_frame>
      <description>MN assay will be measured using cell-derived target viruses for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains in the long-term subset of 770 subjects, overall and by age subgroup.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Immunogenicity Endpoints: For aQIVc, QIV1 and QIV2 vaccines, GMT, GMFI, SCR, SCR difference, and GMT ratio of antibodies measured via MN assay.</measure>
      <time_frame>Day 1 up to Day 365</time_frame>
      <description>MN assay will be measured using cell-derived target viruses for A/H3N2 heterologous vaccine strains in the long-term subset of 770 subjects.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Safety endpoints: For aQIVc, QIV1 and QIV2 vaccines, the percentages of Subjects with Solicited Local Adverse Events, Solicited Systemic Adverse Events, and Severe Solicited Local and/or Systemic AEs.</measure>
      <time_frame>Day 1 to Day 7</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Safety endpoints: For aQIVc, QIV1 and QIV2 vaccines, the percentage of Subjects with Unsolicited Adverse Events.</measure>
      <time_frame>Day to Day 29</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Safety endpoints: For aQIVc, QIV1 and QIV2 vaccines, the percentages of subjects with Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and non-serious Medically Attended Adverse Events (MAAEs).</measure>
      <time_frame>Day 1 to Day 181</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Safety endpoints: For aQIVc, QIV1 and QIV2 vaccines, the percentages of subjects with Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and non-serious Medically Attended Adverse Events (MAAEs).</measure>
      <time_frame>Day 1 to Day 365</time_frame>
      <description>Long-term safety for the long-term subset of 770 subjects</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">7700</enrollment>
    <condition>Influenza, Human</condition>
    <arm_group>
      <arm_group_label>Investigational aQIVc group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>licensed QIV1 group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>licensed QIV2 group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Investigational aQIVc</intervention_name>
      <description>Investigational MF59 Adjuvanted Cell-derived Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.</description>
      <arm_group_label>Investigational aQIVc group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>licensed QIV1</intervention_name>
      <description>Licensed, Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.</description>
      <arm_group_label>licensed QIV1 group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>licensed QIV2</intervention_name>
      <description>Licensed, Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.</description>
      <arm_group_label>licensed QIV2 group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Main Inclusion Criteria:&#xD;
  &#xD;
            -  Individuals, aged 50 years and older, who are healthy or have stable comorbidities&#xD;
               that increase their risk of complications from influenza infection&#xD;
  &#xD;
            -  Individuals who can comply with all study procedures&#xD;
  &#xD;
          Main Exclusion Criteria:&#xD;
  &#xD;
            -  Progressive, unstable, or uncontrolled clinical conditions&#xD;
  &#xD;
            -  Known hypersensitivity or allergy to any study vaccine component&#xD;
  &#xD;
            -  Known history of Guillain-Barré syndrome or other demyelinating disease&#xD;
  &#xD;
            -  Condition representing a contraindication to vaccination or blood draw&#xD;
  &#xD;
            -  Abnormal function of immune system due to known disorder or medication.&#xD;
  &#xD;
            -  Influenza vaccination within 180 days prior to informed consent.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Clinical Program Director</last_name>
      <role>Study Director</role>
      <affiliation>Seqirus</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Clinical Trial Disclosure Manager</last_name>
      <phone>+1 855 358 8966</phone>
      <email>seqirus.clinicaltrials@seqirus.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Use Central Contact</last_name>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>influenza</keyword>
    <keyword>vaccine</keyword>
    <keyword>MF59</keyword>
    <keyword>Adjuvant</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Influenza, Human</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>SEQIRUS supports the release of anonymized subject-level and study-level data in compliance with regulatory requirements, including Clinical Documents which are part of the CTD modules submitted to regulatory agencies for public release.&#xD;
  Summary results disclosure is either in document form (e.g., ICH E3 Clinical Study Report synopsis) or structured data form (such as summary results in ClinicalTrials.gov (United States) or eudract.ema.europa.eu (EU Clinical Trial Registry [EU CTR])).</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_time_frame>SEQIRUS discloses results from clinical studies within 12 months of last patient last visit (LPLV) unless otherwise mandated by local laws or regulations.</ipd_time_frame>
      <ipd_access_criteria>SEQIRUS will consider requests from qualified scientific and medical researchers to disclose protocols, anonymized subject-level data and study-level data when there is medical, scientific and/or public health interest to ensure the safe use of a Seqirus product licensed on or after 1 January 2014 in the United States (US) and/or the European Union (EU). This applies to Seqirus-sponsored interventional studies initiated after 27 September 2007 and ongoing as of 26 December 2007, that have been included as part of a US or EU submission package which received approval in US and EU on or after 1 January 2014 and have been accepted for publication.</ipd_access_criteria>
      <ipd_url>https://www.seqirus.us/partnering</ipd_url>
    </patient_data>
    <!-- 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/NCT06015282
  org study id: V201_03
  nct id: NCT06015282
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  This is a Phase 3, randomized, parallel-group, comparator-controlled, observer-blind,
        multicenter study of immunogenicity and safety in approximately 7700 male and female adults
        aged 50 years and older (approximately equally split between two age groups: 50-64 years; 65
        years and older), who are healthy or have stable comorbidities that increase their risk of
        complications from influenza infection. Three lots of aQIVc will be evaluated for consistency
        and pooled for the comparison with the 2 control vaccines.
  
        Subjects will be randomly assigned to receive 1 of 3 lots of aQIVc, QIV1, or QIV2 in a
        1:1:1:2:2 ratio (for a 3:2:2 ratio for aQIVc, QIV1, and QIV2).
  
        The study will have a treatment period (Day 1 to Day 29) and a follow-up period (Day 30 up to
        Day 181); a subset of 770 subjects will be followed up up to Day 365.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Immunogenicity Endpoint: Humoral immune responses of 3 lots of aQIVc compared in pairs in terms of Day 29 GMT ratio between each pair among the 3 lots, from antibody titers measured via HI assay.
  time frame: Day 29
  description: HI assay will be measured using cell-derived target viruses for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains.
  measure: Immunogenicity Endpoint: Humoral immune responses of aQIVc in comparison with QIV1 and QIV2 vaccines in terms of Day 29 GMT and GMT ratio of antibodies measured via HI assay.
  time frame: Day 29
  description: HI assay will be measured using cell-derived target viruses for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains.
  Noninferiority of aQIVc versus comparator (QIV1 or QIV2) will be demonstrated if the lower limit (LL) of the 2-sided 97.5% CI for the Day 29 GMT ratio (aQIVc/comparator) is ≥0.67 for each of the 4 vaccine strains.
  measure: Immunogenicity Endpoint: Humoral immune responses of aQIVc in comparison with QIV1 and QIV2 vaccines in terms of Day 1 to Day 29 SCR and SCR difference, from antibody titers measured via HI assay.
  time frame: Day 1 and Day 29
  description: HI assay will be measured using cell-derived target viruses for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains.
  SCR is the percentage of subjects with seroconversion (defined as either a prevaccination [Day 1] titer <1:10 and a postvaccination [Day 29] titer ≥1:40, or a prevaccination titer ≥1:10 and a ≥4-fold increase in postvaccination titer).
  Noninferiority of aQIVc versus comparator (QIV1 or QIV2) will be demonstrated if the lower limit (LL) of the 2-sided 97.5% CI for the difference in SCR (aQIVc minus comparator) is ≥-10% for each of the 4 vaccine strains.
  measure: Immunogenicity Endpoint: Humoral immune responses of aQIVc in comparison with QIV1 and QIV2 vaccines in terms of Day 29 GMT and GMT ratio of antibodies measured via HI assay.
  time frame: Day 29
  description: HI assay will be measured using cell-derived target viruses for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains.
  Superiority of aQIVc versus comparator (QIV1 and QIV2) will be demonstrated if the LL of the 2-sided 97.5% CI for the inter-group GMT ratio (aQIVc/comparator) is >1.0 for each of the 4 vaccine strains.
  measure: Immunogenicity Endpoints: For aQIVc, QIV1, and QIV2 vaccines, Day 29 GMT, Day 1 to Day 29 GMFI, Percentage of subjects with HI titer ≥1:40 at Day 29, Day 1 to Day 29 SCR, SCR differences and GMT ratio of antibodies measured via HI assay.
  time frame: Day 1 and Day 29
  description: HI assay will be measured using cell-derived target viruses for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains, overall and by age subgroup.
  measure: Immunogenicity Endpoints: For aQIVc and QIV1 vaccines, Day 29 GMT, Day 1 to Day 29 GMFI, Percentage of subjects with HI titer ≥1:40 at Day 29, Day 1 to Day 29 SCR, SCR differences, and GMT ratio of antibodies measured via HI assay.
  time frame: Day 1 and Day 29
  description: HI assay will be measured using egg-derived target viruses for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains in the HI-egg subset of 2750 subjects, overall and by age subgroup.
  measure: Immunogenicity Endpoints: For aQIVc, QIV1 and QIV2 vaccines, GMT, GMFI, Percentage of subjects with HI titer ≥1:40, SCR, SCR differences, and GMT ratio of antibodies measured via HI assay.
  time frame: Day 1 up to Day 365
  description: HI assay will be measured using cell-derived target viruses for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains in the long-term subset of 770 subjects, overall and by age subgroup.
  measure: Immunogenicity Endpoints: For aQIVc, QIV1 and QIV2 vaccines, GMT, GMFI, SCR, SCR difference, and GMT ratio of antibodies measured via MN assay.
  time frame: Day 1 up to Day 365
  description: MN assay will be measured using cell-derived target viruses for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria vaccine strains in the long-term subset of 770 subjects, overall and by age subgroup.
  measure: Immunogenicity Endpoints: For aQIVc, QIV1 and QIV2 vaccines, GMT, GMFI, SCR, SCR difference, and GMT ratio of antibodies measured via MN assay.
  time frame: Day 1 up to Day 365
  description: MN assay will be measured using cell-derived target viruses for A/H3N2 heterologous vaccine strains in the long-term subset of 770 subjects.
  measure: Safety endpoints: For aQIVc, QIV1 and QIV2 vaccines, the percentages of Subjects with Solicited Local Adverse Events, Solicited Systemic Adverse Events, and Severe Solicited Local and/or Systemic AEs.
  time frame: Day 1 to Day 7
  measure: Safety endpoints: For aQIVc, QIV1 and QIV2 vaccines, the percentage of Subjects with Unsolicited Adverse Events.
  time frame: Day to Day 29
  measure: Safety endpoints: For aQIVc, QIV1 and QIV2 vaccines, the percentages of subjects with Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and non-serious Medically Attended Adverse Events (MAAEs).
  time frame: Day 1 to Day 181
  measure: Safety endpoints: For aQIVc, QIV1 and QIV2 vaccines, the percentages of subjects with Serious Adverse Events (SAEs), AEs Leading to Withdrawal, Adverse Events of Special Interest (AESI) and non-serious Medically Attended Adverse Events (MAAEs).
  time frame: Day 1 to Day 365
  description: Long-term safety for the long-term subset of 770 subjects
  arm group label: Investigational aQIVc group
  arm group type: Experimental
  arm group label: licensed QIV1 group
  arm group type: Active Comparator
  arm group label: licensed QIV2 group
  arm group type: Active Comparator
  intervention type: Biological
  intervention name: Investigational aQIVc
  description: Investigational MF59 Adjuvanted Cell-derived Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
  arm group label: Investigational aQIVc group
  intervention type: Biological
  intervention name: licensed QIV1
  description: Licensed, Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.
  arm group label: licensed QIV1 group
  intervention type: Biological
  intervention name: licensed QIV2
  description: Licensed, Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.
  arm group label: licensed QIV2 group
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Clinical Program Director
  role: Study Director
  affiliation: Seqirus
  last name: Clinical Trial Disclosure Manager
  phone: +1 855 358 8966
  email: seqirus.clinicaltrials@seqirus.com
  last name: Use Central Contact
  responsible party type: Sponsor
  mesh term: Influenza, Human
  sharing ipd: Yes
  ipd description: SEQIRUS supports the release of anonymized subject-level and study-level data in compliance with regulatory requirements, including Clinical Documents which are part of the CTD modules submitted to regulatory agencies for public release.
  Summary results disclosure is either in document form (e.g., ICH E3 Clinical Study Report synopsis) or structured data form (such as summary results in ClinicalTrials.gov (United States) or eudract.ema.europa.eu (EU Clinical Trial Registry [EU CTR])).
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd time frame: SEQIRUS discloses results from clinical studies within 12 months of last patient last visit (LPLV) unless otherwise mandated by local laws or regulations.
  ipd access criteria: SEQIRUS will consider requests from qualified scientific and medical researchers to disclose protocols, anonymized subject-level data and study-level data when there is medical, scientific and/or public health interest to ensure the safe use of a Seqirus product licensed on or after 1 January 2014 in the United States (US) and/or the European Union (EU). This applies to Seqirus-sponsored interventional studies initiated after 27 September 2007 and ongoing as of 26 December 2007, that have been included as part of a US or EU submission package which received approval in US and EU on or after 1 January 2014 and have been accepted for publication.
  ipd url: https://www.seqirus.us/partnering