<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/NCT02225327</url>
  </required_header>
  <id_info>
    <org_study_id>FLUADPPV23</org_study_id>
    <nct_id>NCT02225327</nct_id>
  </id_info>
  <brief_title>MF59-adjuvanted Influenza Vaccine and 23-valent Pneumococcal Polysaccharide Vaccine</brief_title>
  <official_title>Immunogenicity and Safety of MF59-adjuvanted Trivalent Influenza Vaccine (Fluad) and 23-valent Pneumococcal Polysaccharide Vaccine (PPV23) in the Elderly: Single Versus Concomitant Vaccination</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Korea University Guro Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Novartis</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Korea University Guro Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Similar to children, adults frequently visit outpatient clinics to get two or more kinds of&#xD;
      vaccines at the same time: pneumococcal vaccine, influenza vaccine, Td (diphtheria and&#xD;
      tetanus) vaccine, HPV (human papilloma virus) vaccine, meningococcal vaccine, zoster vaccine,&#xD;
      etc. This study is intended to evaluate the immunogenicity and safety of concomitant&#xD;
      administration of 23-valent pneumococcal polysaccharide vaccine (PPV23, Prodiax) and MF59&#xD;
      adjuvanted trivalent influenza vaccine in the elderly subjects aged ≥65 years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During influenza season, concomitant influenza and pneumococcal vaccination would be an&#xD;
      effective strategy to enhance pneumococcal vaccine coverage rate in high-risk adults.&#xD;
      However, the immunogenicity and safety of concomitant vaccination need to be further&#xD;
      investigated. There is data on immunogenicity and safety after concomitant administration of&#xD;
      pneumococcal polysaccharide vaccine (PPV) and unadjuvanted influenza vaccine; no interference&#xD;
      was noted between two vaccines. However, there are no data for MF59 adjuvanted influenza&#xD;
      vaccine with pneumococcal vaccine. MF59 only locally reacts for immune response, so&#xD;
      immunogenicity should be assessed for both vaccines injected in same arm versus different&#xD;
      arms.&#xD;
&#xD;
      This study is intended to evaluate the immunogenicity and safety of concomitant&#xD;
      MF59-adjuvanted trivalent influenza vaccine (MF59-aTIV, Fluad) and 23-valent pneumococcal&#xD;
      polysaccharide vaccine (PPV23, Prodiax) vaccination in the elderly subjects aged ≥65 years.&#xD;
      Healthy elderly subjects (N = 424) are randomized in a 1:1:1:1 ratio to receive MF59-aTIV&#xD;
      alone (group 1), MF59-aTIV +PPV23 at different arm (group 2), MF59-aTIV +PPV23 at same arm&#xD;
      (group 3) or PPV23 alone (group 4).&#xD;
&#xD;
      Hemagglutination inhibition (HI) assay and multiplex opsono-phagocytic killing assay (MOPA)&#xD;
      will be used to compare the immunogenicity of each vaccine after single or concomitant&#xD;
      vaccination at pre-vaccination and 1 month post-vaccination. MOPA will be taken for four&#xD;
      serotypes (5, 6B, 18C and 19A).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2013</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Seroconversion rates (A/H1N1, A/H3N2, and B)</measure>
    <time_frame>Outcome measure will be assessed at two points (baseline and 4 weeks after vaccination)</time_frame>
    <description>a post-vaccination titer ≥1:40 in subjects with a pre-vaccination titer of &lt;1:10 or a ≥4-fold titer increase in subjects with a pre-vaccination titer of ≥1:10</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Seroprotection rates (A/H1N1, A/H3N2, and B)</measure>
    <time_frame>Outcome measure will be assessed at two points (baseline and 4 weeks after vaccination).</time_frame>
    <description>Percentage of subjects with a post-vaccination titer ≥1:40</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GMT folds (A/H1N1, A/H3N2, and B)</measure>
    <time_frame>Outcome measure will be assessed at two points (baseline and 4 weeks after vaccination.</time_frame>
    <description>GMT-fold change: GMT ratio of the post-vaccination titer to pre-vaccination titer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opsonophagocytic assay (OPA) titers for four serotypes of PPV23 (serotypes 5, 6B, 18C and 19A)</measure>
    <time_frame>Outcome measure will be assessed at two points (baseline and 4 weeks after vaccination).</time_frame>
    <description>OPA geometric mean titers for four PPV23 serotypes with corresponding 2-sided 95% confidence intervals will be compared between groups receiving PPV23: MF59-adjuvanted TIV + PPV23 at different arm, MF59-adjuvanted TIV + PPV23 at same arm and PPV23 alone.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">224</enrollment>
  <condition>Influenza, Human</condition>
  <condition>Pneumococcal Infections</condition>
  <arm_group>
    <arm_group_label>Fluad alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>56 Fluad recipients: one vaccine injection administered on Day 0</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fluad and PPV23 on the different arms</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>56 concomitant Fluad-PPV23 recipients on the different arms: one dose of each vaccine administered on Day 0</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fluad and PPV23 on the same arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>56 concomitant Fluad-PPV23 recipients on the same arm with 1 inch distance: one dose of each vaccine administered on Day 0</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PPV23 alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>56 PPV23 recipients: one vaccine injection administered on Day 0</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Fluad alone</intervention_name>
    <description>Fluad</description>
    <arm_group_label>Fluad alone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Fluad and PPV23 on the different arms</intervention_name>
    <description>Fluad and Prodiax</description>
    <arm_group_label>Fluad and PPV23 on the different arms</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Fluad and PPV23 on the same arm</intervention_name>
    <description>Fluad and Prodiax</description>
    <arm_group_label>Fluad and PPV23 on the same arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>PPV23 alone</intervention_name>
    <description>Prodiax</description>
    <arm_group_label>PPV23 alone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 65 years of age who are eligible for the study vaccines;&#xD;
&#xD;
          -  Who have given written informed consent at the time of enrollment);&#xD;
&#xD;
          -  Those who are available for all the visits scheduled in the study;&#xD;
&#xD;
          -  Subjects In good health as determined by medical history, physical examination and&#xD;
             clinical judgment of the investigator&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of egg allergy&#xD;
&#xD;
          -  History of influenza vaccination in previous 6 months&#xD;
&#xD;
          -  History of any pneumococcal vaccination&#xD;
&#xD;
          -  Documented S. pneumonia infection in the previous 5 years&#xD;
&#xD;
          -  Chemotherapy for malignancy within the past 30 days&#xD;
&#xD;
          -  High-dose systemic steroid (prednisone ≥0.5 mg/kg/day) in the past 30 days&#xD;
&#xD;
          -  Receipt of blood product within 6 months before enrollment&#xD;
&#xD;
          -  Significant acute or chronic infection within the previous 7 days or fever within the&#xD;
             previous day&#xD;
&#xD;
          -  Any serious chronic or progressive disease&#xD;
&#xD;
          -  Any condition that might interfere with the study results.&#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_official>
    <last_name>Hee Jin Cheong, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Korea University Guro Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Joon Young Song, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Korea University Guro Hospital</affiliation>
  </overall_official>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 22, 2014</study_first_submitted>
  <study_first_submitted_qc>August 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 26, 2014</study_first_posted>
  <last_update_submitted>August 26, 2014</last_update_submitted>
  <last_update_submitted_qc>August 26, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 27, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Korea University Guro Hospital</investigator_affiliation>
    <investigator_full_name>Hee Jin Cheong</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
    <mesh_term>Pneumococcal Infections</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT02225327
org study id: FLUADPPV23
nct id: NCT02225327
lead sponsor: 
collaborator: 
has dmc: Yes
Similar to children, adults frequently visit outpatient clinics to get two or more kinds of
      vaccines at the same time: pneumococcal vaccine, influenza vaccine, Td (diphtheria and
      tetanus) vaccine, HPV (human papilloma virus) vaccine, meningococcal vaccine, zoster vaccine,
      etc. This study is intended to evaluate the immunogenicity and safety of concomitant
      administration of 23-valent pneumococcal polysaccharide vaccine (PPV23, Prodiax) and MF59
      adjuvanted trivalent influenza vaccine in the elderly subjects aged ≥65 years.
During influenza season, concomitant influenza and pneumococcal vaccination would be an
      effective strategy to enhance pneumococcal vaccine coverage rate in high-risk adults.
      However, the immunogenicity and safety of concomitant vaccination need to be further
      investigated. There is data on immunogenicity and safety after concomitant administration of
      pneumococcal polysaccharide vaccine (PPV) and unadjuvanted influenza vaccine; no interference
      was noted between two vaccines. However, there are no data for MF59 adjuvanted influenza
      vaccine with pneumococcal vaccine. MF59 only locally reacts for immune response, so
      immunogenicity should be assessed for both vaccines injected in same arm versus different
      arms.

      This study is intended to evaluate the immunogenicity and safety of concomitant
      MF59-adjuvanted trivalent influenza vaccine (MF59-aTIV, Fluad) and 23-valent pneumococcal
      polysaccharide vaccine (PPV23, Prodiax) vaccination in the elderly subjects aged ≥65 years.
      Healthy elderly subjects (N = 424) are randomized in a 1:1:1:1 ratio to receive MF59-aTIV
      alone (group 1), MF59-aTIV +PPV23 at different arm (group 2), MF59-aTIV +PPV23 at same arm
      (group 3) or PPV23 alone (group 4).

      Hemagglutination inhibition (HI) assay and multiplex opsono-phagocytic killing assay (MOPA)
      will be used to compare the immunogenicity of each vaccine after single or concomitant
      vaccination at pre-vaccination and 1 month post-vaccination. MOPA will be taken for four
      serotypes (5, 6B, 18C and 19A).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Seroconversion rates (A/H1N1, A/H3N2, and B)
time frame: Outcome measure will be assessed at two points (baseline and 4 weeks after vaccination)
description: a post-vaccination titer ≥1:40 in subjects with a pre-vaccination titer of <1:10 or a ≥4-fold titer increase in subjects with a pre-vaccination titer of ≥1:10
measure: Seroprotection rates (A/H1N1, A/H3N2, and B)
time frame: Outcome measure will be assessed at two points (baseline and 4 weeks after vaccination).
description: Percentage of subjects with a post-vaccination titer ≥1:40
measure: GMT folds (A/H1N1, A/H3N2, and B)
time frame: Outcome measure will be assessed at two points (baseline and 4 weeks after vaccination.
description: GMT-fold change: GMT ratio of the post-vaccination titer to pre-vaccination titer
measure: Opsonophagocytic assay (OPA) titers for four serotypes of PPV23 (serotypes 5, 6B, 18C and 19A)
time frame: Outcome measure will be assessed at two points (baseline and 4 weeks after vaccination).
description: OPA geometric mean titers for four PPV23 serotypes with corresponding 2-sided 95% confidence intervals will be compared between groups receiving PPV23: MF59-adjuvanted TIV + PPV23 at different arm, MF59-adjuvanted TIV + PPV23 at same arm and PPV23 alone.
arm group label: Fluad alone
arm group type: Active Comparator
description: 56 Fluad recipients: one vaccine injection administered on Day 0
arm group label: Fluad and PPV23 on the different arms
arm group type: Active Comparator
description: 56 concomitant Fluad-PPV23 recipients on the different arms: one dose of each vaccine administered on Day 0
arm group label: Fluad and PPV23 on the same arm
arm group type: Active Comparator
description: 56 concomitant Fluad-PPV23 recipients on the same arm with 1 inch distance: one dose of each vaccine administered on Day 0
arm group label: PPV23 alone
arm group type: Active Comparator
description: 56 PPV23 recipients: one vaccine injection administered on Day 0
intervention type: Biological
intervention name: Fluad alone
description: Fluad
arm group label: Fluad alone
intervention type: Biological
intervention name: Fluad and PPV23 on the different arms
description: Fluad and Prodiax
arm group label: Fluad and PPV23 on the different arms
intervention type: Biological
intervention name: Fluad and PPV23 on the same arm
description: Fluad and Prodiax
arm group label: Fluad and PPV23 on the same arm
intervention type: Biological
intervention name: PPV23 alone
description: Prodiax
arm group label: PPV23 alone
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Hee Jin Cheong, MD, PhD
role: Principal Investigator
affiliation: Korea University Guro Hospital
last name: Joon Young Song, MD, PhD
role: Study Director
affiliation: Korea University Guro Hospital
responsible party type: Principal Investigator
investigator affiliation: Korea University Guro Hospital
investigator full name: Hee Jin Cheong
investigator title: Professor
mesh term: Influenza, Human
mesh term: Pneumococcal Infections