<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/NCT02213432</url>
  </required_header>
  <id_info>
    <org_study_id>1407-057-593</org_study_id>
    <nct_id>NCT02213432</nct_id>
  </id_info>
  <brief_title>Influenza Vaccination in Cancer Patients</brief_title>
  <official_title>Randomized Controlled Trial to Compare Seroprotection Rate According to Timing of Influenza Vaccination in Adult Patients With Non-Hematologic Malignancies Receiving Scheduled Cytotoxic Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Green Cross Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the timing of influenza vaccination to induce&#xD;
      higher antibody response in adult patients with non-hematologic malignancies receiving&#xD;
      scheduled cytotoxic chemotherapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The participants will be stratified by the age (cut off; 60 years old) and last year&#xD;
      influenza vaccination, and block-randomized to 2 groups; Day 1 vaccination group and Day 11&#xD;
      vaccination group.&#xD;
&#xD;
      Day 1 group will be vaccinated at Day 1, when the cycle of chemotherapy begins. Day 11 group&#xD;
      will get the vaccine at Day 11, 10 days after chemotherapy begins.&#xD;
&#xD;
      As the rate of completion of study in the Day 11 group is anticipated lower than Day 1 group,&#xD;
      we will assign the participants into Day 1: Day 11 with the different ratio; 4:5.&#xD;
&#xD;
      Hemagglutination inhibition Ab titre at pre-vaccination and post-vaccination (21-28 days&#xD;
      after vaccination) will be examined in all participants.&#xD;
&#xD;
      All the participants will be asked if they have any contraindication for influenza vaccine by&#xD;
      a physician before vaccination. And they will be monitored for any adverse reaction of the&#xD;
      vaccination after 2-4 days(phone calling) and after 21-28 days (visiting the hospital).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Insufficient enrollment&#xD;
  </why_stopped>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <phase>N/A</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>Seroprotection rate</measure>
    <time_frame>21-28 days after vaccination</time_frame>
    <description>The percentage of vaccine recipients with a serum haemagglutination inhibition(HI) titre ≥40 post vaccination (21-28 days)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Seroconversion factor</measure>
    <time_frame>21-28 days after vaccination</time_frame>
    <description>Seroconversion factor is defined as mean fold increases in geometric mean titers of the haemagglutination inhibition(HI) after vaccination, expressed as a multiple.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Seroconversion rate</measure>
    <time_frame>21-28 days after vaccination</time_frame>
    <description>Seroconversion rate is defined as the percentage of vaccine recipients with a fourfold increase or more in post-vaccination HI titre</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric mean titre of HI</measure>
    <time_frame>21-28 days after vaccination</time_frame>
    <description>Geometric mean titers of HI (haemagglutination inhibition) after vaccination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vaccine-related adverse events</measure>
    <time_frame>within 28 days</time_frame>
    <description>the proportion of patients with any or serious vaccine-related adverse events</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">97</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Day 1 vaccination</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Different timing of influenza vaccination: Day 1&#xD;
Day 1 vaccination group: patients will be vaccinated against influenza at the day (Day 1) when chemotherapy starts.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Day 11 vaccination</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Different timing of influenza vaccination: Day 11&#xD;
Day 11 vaccination group: patients will be vaccinated against influenza at the 11th days after chemotherapy starts</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Different timing of influenza vaccination</intervention_name>
    <description>The timing of Influenza vaccination for cancer patients receiving chemotherapy will be differently assigned to day 1 or day 11.</description>
    <arm_group_label>Day 1 vaccination</arm_group_label>
    <arm_group_label>Day 11 vaccination</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients who receive the scheduled cytotoxic chemotherapy every 3 weeks because of&#xD;
             solid cancer.&#xD;
&#xD;
             Specific definition of each term is like following:&#xD;
&#xD;
               -  The solid cancer includes various kinds of cancer except hematologic and lymphoid&#xD;
                  malignancies.&#xD;
&#xD;
               -  Cytotoxic chemotherapy includes adjuvant, neoadjuvant or palliative purpose of&#xD;
                  chemotherapy with the planned duration at least over 3 cycles every 3 weeks.&#xD;
&#xD;
               -  Targeted therapy drugs like as monoclonal antibody, tyrosine kinase inhibitor or&#xD;
                  oral chemotherapy drugs like as Xeloda are excluded.&#xD;
&#xD;
          2. Patients who did not receive the influenza vaccination yet in the current year.&#xD;
&#xD;
          3. Older than 19 years&#xD;
&#xD;
          4. Eastern Cooperative Oncology Group (ECOG) performance status is 0, 1, or 2&#xD;
&#xD;
          5. Cell blood count meets following criteria:&#xD;
&#xD;
               -  Neutrophile count ≥ 1.5 x 10^9/L&#xD;
&#xD;
               -  Platelet count ≥ 100 x 10^9/L&#xD;
&#xD;
               -  Hemoglobin ≥ 8 g/dL&#xD;
&#xD;
          6. Patients who can understand and agreed with the informed consents.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who have any contraindication for influenza vaccination.&#xD;
&#xD;
          2. Patients who are supposed to receive the last chemotherapy at the enrollment&#xD;
&#xD;
          3. Patients who receive simultaneous radiation therapy with cytotoxic chemotherapy&#xD;
&#xD;
          4. Patients who receive any immunosuppressant (excluding steroid for anti-emetic effect)&#xD;
&#xD;
          5. Patients with HIV and low CD 4+ T cell count (&lt; 500/uL)&#xD;
&#xD;
          6. Patients with autoimmune disease who are anticipated to have a problem with&#xD;
             immunogenicity for vaccine&#xD;
&#xD;
          7. Patients who have transplanted organ and receive immunosuppressants&#xD;
&#xD;
          8. Patients who are supposed to get prophylactic G-CSF after chemotherapy&#xD;
&#xD;
          9. Patients who are suspected to have active infectious disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wan Beom Park, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 11, 2014</study_first_posted>
  <last_update_submitted>February 22, 2016</last_update_submitted>
  <last_update_submitted_qc>February 22, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 24, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Wan Beom Park</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>influenza vaccine</keyword>
  <keyword>cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</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/NCT02213432
org study id: 1407-057-593
nct id: NCT02213432
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine the timing of influenza vaccination to induce
      higher antibody response in adult patients with non-hematologic malignancies receiving
      scheduled cytotoxic chemotherapy.
The participants will be stratified by the age (cut off; 60 years old) and last year
      influenza vaccination, and block-randomized to 2 groups; Day 1 vaccination group and Day 11
      vaccination group.

      Day 1 group will be vaccinated at Day 1, when the cycle of chemotherapy begins. Day 11 group
      will get the vaccine at Day 11, 10 days after chemotherapy begins.

      As the rate of completion of study in the Day 11 group is anticipated lower than Day 1 group,
      we will assign the participants into Day 1: Day 11 with the different ratio; 4:5.

      Hemagglutination inhibition Ab titre at pre-vaccination and post-vaccination (21-28 days
      after vaccination) will be examined in all participants.

      All the participants will be asked if they have any contraindication for influenza vaccine by
      a physician before vaccination. And they will be monitored for any adverse reaction of the
      vaccination after 2-4 days(phone calling) and after 21-28 days (visiting the hospital).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Seroprotection rate
time frame: 21-28 days after vaccination
description: The percentage of vaccine recipients with a serum haemagglutination inhibition(HI) titre ≥40 post vaccination (21-28 days)
measure: Seroconversion factor
time frame: 21-28 days after vaccination
description: Seroconversion factor is defined as mean fold increases in geometric mean titers of the haemagglutination inhibition(HI) after vaccination, expressed as a multiple.
measure: Seroconversion rate
time frame: 21-28 days after vaccination
description: Seroconversion rate is defined as the percentage of vaccine recipients with a fourfold increase or more in post-vaccination HI titre
measure: Geometric mean titre of HI
time frame: 21-28 days after vaccination
description: Geometric mean titers of HI (haemagglutination inhibition) after vaccination
measure: Vaccine-related adverse events
time frame: within 28 days
description: the proportion of patients with any or serious vaccine-related adverse events
arm group label: Day 1 vaccination
arm group type: Experimental
description: Different timing of influenza vaccination: Day 1
Day 1 vaccination group: patients will be vaccinated against influenza at the day (Day 1) when chemotherapy starts.
arm group label: Day 11 vaccination
arm group type: Active Comparator
description: Different timing of influenza vaccination: Day 11
Day 11 vaccination group: patients will be vaccinated against influenza at the 11th days after chemotherapy starts
intervention type: Biological
intervention name: Different timing of influenza vaccination
description: The timing of Influenza vaccination for cancer patients receiving chemotherapy will be differently assigned to day 1 or day 11.
arm group label: Day 1 vaccination
arm group label: Day 11 vaccination
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Wan Beom Park, MD, PhD
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Wan Beom Park
investigator title: Associate Professor
mesh term: Influenza, Human