<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/NCT01666535</url>
  </required_header>
  <id_info>
    <org_study_id>REMICADEIBD4010</org_study_id>
    <nct_id>NCT01666535</nct_id>
  </id_info>
  <brief_title>Infliximab IBD Influenza Vaccine Study</brief_title>
  <official_title>Effect of Influenza Vaccination Timing on Immune Response in Patients With Inflammatory Bowel Disease on Infliximab Therapy: A Randomized Equivalence Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Calgary</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Janssen Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Calgary</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators will compare the immunogenicity of influenza vaccine in adults and children&#xD;
      with inflammatory bowel disease by timing of vaccine in relation to maintenance infliximab&#xD;
      dosing. The primary objective is to compare the proportion of IBD patients on maintenance&#xD;
      infliximab who mount serologic protection to each component of the influenza vaccination&#xD;
      between patients vaccinated on day of infliximab infusion (Day 0 to 4) and patients&#xD;
      vaccinated at the mid-point between infliximab infusions (Day 21 to 28). Serologic protection&#xD;
      will be defined by a hemagglutination-inhibition titer ≥ 1:40. The secondary objective is to&#xD;
      compare the proportion of IBD patients who mount an immunogenic response (≥ 4-fold increase&#xD;
      from pre to post-vaccination titer) to each component of the influenza vaccination between&#xD;
      patients vaccinated on day of infliximab infusion and those vaccinated at the mid-point.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</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>Serologic protection</measure>
    <time_frame>28 days ± 3 days after influenza vaccination</time_frame>
    <description>To compare the proportion of IBD patients on maintenance infliximab who mount serologic protection to each component of the influenza vaccination between patients vaccinated on day of infliximab infusion (Day 0 to 4) and patients vaccinated at the mid-point between infliximab infusions (Day 21 to 28). Serologic protection will be defined by a hemagglutination-inhibition titer ≥ 1:40.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Immunogenic response</measure>
    <time_frame>28 days ± 3 days after influenza vaccination</time_frame>
    <description>To compare the proportion of IBD patients on maintenance infliximab who mount an immunogenic response to each component of the influenza vaccination between patients vaccinated on day of infliximab infusion (Day 0 to 4) and patients vaccinated at the mid-point between infliximab infusions (Day 21 to 28). Immunogenicity will be defined as a fourfold or greater differences in titer between pre and post-vaccination sera.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of participants with serious adverse events</measure>
    <time_frame>3 days post vaccination</time_frame>
    <description>To evaluate the number of participants with early serious adverse reactions (≤ 3 days post-vaccination)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in disease activity from baseline</measure>
    <time_frame>Four week post-vaccination</time_frame>
    <description>To evaluate the change in disease activity score from baseline using the validated instruments of the Pediatric Ulcerative Colitis Activity Index for participants with Ulcerative Coltiis and the Harvey Bradshaw Index for participants with Crohn's Disease</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">137</enrollment>
  <condition>Inflammatory Bowel Disease</condition>
  <arm_group>
    <arm_group_label>Influenza vaccination Timing #1</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Influenza vaccination administered on the same day as infliximab administration (Day 0 to 4).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Influenza vaccination Timing #2</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Influenza vaccination administered at the mid-point between infliximab infusions (Day 21 to 28)</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Influenza vaccination</intervention_name>
    <arm_group_label>Influenza vaccination Timing #1</arm_group_label>
    <arm_group_label>Influenza vaccination Timing #2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of IBD established by accepted criteria&#xD;
&#xD;
          -  On maintenance infliximab administered every 6 to 8 weeks (already received at least 6&#xD;
             weeks of infliximab)&#xD;
&#xD;
          -  Between ages 9 and 60 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnancy&#xD;
&#xD;
          2. Hypersensitivity reaction to previous dose of influenza vaccine&#xD;
&#xD;
          3. Known hypersensitivity to eggs or chicken or other components of influenza vaccine&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jennifer deBruyn, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Calgary</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Calgary</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T3B 6A8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>August 8, 2012</study_first_submitted>
  <study_first_submitted_qc>August 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <last_update_submitted>May 5, 2016</last_update_submitted>
  <last_update_submitted_qc>May 5, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 9, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Calgary</investigator_affiliation>
    <investigator_full_name>Jennifer deBruyn</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Influenza vaccine</keyword>
  <keyword>Immune response</keyword>
  <keyword>Remicade (infliximab)</keyword>
  <keyword>Inflammatory bowel disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
    <mesh_term>Intestinal Diseases</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</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/NCT01666535
org study id: REMICADEIBD4010
nct id: NCT01666535
lead sponsor: 
collaborator: 
has dmc: No
The investigators will compare the immunogenicity of influenza vaccine in adults and children
      with inflammatory bowel disease by timing of vaccine in relation to maintenance infliximab
      dosing. The primary objective is to compare the proportion of IBD patients on maintenance
      infliximab who mount serologic protection to each component of the influenza vaccination
      between patients vaccinated on day of infliximab infusion (Day 0 to 4) and patients
      vaccinated at the mid-point between infliximab infusions (Day 21 to 28). Serologic protection
      will be defined by a hemagglutination-inhibition titer ≥ 1:40. The secondary objective is to
      compare the proportion of IBD patients who mount an immunogenic response (≥ 4-fold increase
      from pre to post-vaccination titer) to each component of the influenza vaccination between
      patients vaccinated on day of infliximab infusion and those vaccinated at the mid-point.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Serologic protection
time frame: 28 days ± 3 days after influenza vaccination
description: To compare the proportion of IBD patients on maintenance infliximab who mount serologic protection to each component of the influenza vaccination between patients vaccinated on day of infliximab infusion (Day 0 to 4) and patients vaccinated at the mid-point between infliximab infusions (Day 21 to 28). Serologic protection will be defined by a hemagglutination-inhibition titer ≥ 1:40.
measure: Immunogenic response
time frame: 28 days ± 3 days after influenza vaccination
description: To compare the proportion of IBD patients on maintenance infliximab who mount an immunogenic response to each component of the influenza vaccination between patients vaccinated on day of infliximab infusion (Day 0 to 4) and patients vaccinated at the mid-point between infliximab infusions (Day 21 to 28). Immunogenicity will be defined as a fourfold or greater differences in titer between pre and post-vaccination sera.
measure: Number of participants with serious adverse events
time frame: 3 days post vaccination
description: To evaluate the number of participants with early serious adverse reactions (≤ 3 days post-vaccination)
measure: Change in disease activity from baseline
time frame: Four week post-vaccination
description: To evaluate the change in disease activity score from baseline using the validated instruments of the Pediatric Ulcerative Colitis Activity Index for participants with Ulcerative Coltiis and the Harvey Bradshaw Index for participants with Crohn's Disease
arm group label: Influenza vaccination Timing #1
arm group type: Other
description: Influenza vaccination administered on the same day as infliximab administration (Day 0 to 4).
arm group label: Influenza vaccination Timing #2
arm group type: Other
description: Influenza vaccination administered at the mid-point between infliximab infusions (Day 21 to 28)
intervention type: Biological
intervention name: Influenza vaccination
arm group label: Influenza vaccination Timing #1
arm group label: Influenza vaccination Timing #2
criteria: 
gender: All
minimum age: 9 Years
maximum age: 60 Years
healthy volunteers: No
last name: Jennifer deBruyn, MD
role: Principal Investigator
affiliation: University of Calgary
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Calgary
investigator full name: Jennifer deBruyn
investigator title: Assistant Professor
mesh term: Influenza, Human
mesh term: Intestinal Diseases
mesh term: Inflammatory Bowel Diseases