<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/NCT02263027</url>
  </required_header>
  <id_info>
    <org_study_id>14-0808</org_study_id>
    <nct_id>NCT02263027</nct_id>
  </id_info>
  <brief_title>Do Some Healthy Adults Consistently Have Systemic Reactions to Influenza Vaccines?</brief_title>
  <official_title>Do Some Healthy Adults Consistently Have Systemic Reactions to Trivalent Inactivated Split Virus Influenza Vaccines?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mount Sinai Hospital, Canada</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mount Sinai Hospital, Canada</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will recruit 35 healthcare workers who had systemic reactions to influenza vaccine&#xD;
      the last 2 times they were vaccinated, to ask whether influenza vaccine is indeed associated&#xD;
      with systemic reactions in these workers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Randomized controlled trials of split virus vaccines in healthy adults have not been able to&#xD;
      detect an increase in systemic adverse events compared to control vaccination. These trials&#xD;
      do identify a non-trivial risk of systemic symptoms occurring in the week after both placebo&#xD;
      and vaccine. There is a small population of healthcare workers who report consistent systemic&#xD;
      symptoms after split virus vaccination which may occur because a small group of healthy&#xD;
      adults have true physical reactions to components of the vaccine or excipients. If this is&#xD;
      true, then alternatives - such as the use of subunit vaccines or live attenuated nasal spray&#xD;
      vaccines - might be expected to be better tolerated by these people.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</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>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Systemic adverse event</measure>
    <time_frame>7 days after each injection</time_frame>
    <description>Any systemic adverse event, self-reported</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>Vaccine, then placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 injection of trivalent inactivated influenza vaccine, 0.5mL/dose, as approved for use in Canada for season of enrolment followed by 1 injection of normal saline placebo, 0.5mL/dose, 28 days later</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo, then vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 injection of normal saline placebo, 0.5mL/dose followed by 1 injection of trivalent inactivated influenza vaccine, 0.5mL/dose, as approved for use in Canada for season of enrolment, 28 days later</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Vaccine</intervention_name>
    <description>Licensed trivalent inactivated influenza vaccine</description>
    <arm_group_label>Placebo, then vaccine</arm_group_label>
    <arm_group_label>Vaccine, then placebo</arm_group_label>
    <other_name>Trivalent inactivated influenza vaccine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Employed or volunteer in a healthcare facility or an ambulatory care setting providing&#xD;
             healthcare&#xD;
&#xD;
          -  By self report, have had 2 or more doses of trivalent inactivated influenza vaccine&#xD;
             (TIIV) in the last 15 years, and after at least the last 2 vaccine doses have had the&#xD;
             same systemic adverse event in the 7 days after vaccination, including: fever, chills,&#xD;
             myalgia, arthralgia, fatigue, headache, or insomnia;&#xD;
&#xD;
          -  Consent to the study, including two injections one month apart, with one being placebo&#xD;
             and one a dose of TIIV;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has a contraindication to TIIV (previous allergic reaction to a dose of vaccine, or&#xD;
             Guillain Barre syndrome with onset within 6 weeks of vaccination);&#xD;
&#xD;
          -  Has previously received a dose of TIIV for the current influenza season.&#xD;
&#xD;
          -  Receipt of another vaccine, or initiation of new medication within 7 days of the study&#xD;
             injection (participant may enter the study as long as the gap between other&#xD;
             vaccine/initiation of new medication is &gt;7 days);&#xD;
&#xD;
          -  Moderate or severe acute illness or active infection or fever (temperature ≥37.8oC) on&#xD;
             the day a dose of study medication due (participant may receive injection 48 hours&#xD;
             after symptoms have resolved and body temperature has returned to normal without the&#xD;
             use of antipyretics.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>69 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Allison J McGeer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>MOUNT SINAI HOSPITAL</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mount Sinai Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>October 8, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>January 13, 2016</last_update_submitted>
  <last_update_submitted_qc>January 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 14, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>influenza vaccine</keyword>
  <keyword>adult</keyword>
  <keyword>safety</keyword>
  <keyword>reactogenicity</keyword>
  <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>
  <pending_results>
    <submitted>August 16, 2019</submitted>
    <returned>September 18, 2019</returned>
  </pending_results>
  <!-- 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/NCT02263027
org study id: 14-0808
nct id: NCT02263027
lead sponsor: 
has dmc: No
This study will recruit 35 healthcare workers who had systemic reactions to influenza vaccine
      the last 2 times they were vaccinated, to ask whether influenza vaccine is indeed associated
      with systemic reactions in these workers.
Randomized controlled trials of split virus vaccines in healthy adults have not been able to
      detect an increase in systemic adverse events compared to control vaccination. These trials
      do identify a non-trivial risk of systemic symptoms occurring in the week after both placebo
      and vaccine. There is a small population of healthcare workers who report consistent systemic
      symptoms after split virus vaccination which may occur because a small group of healthy
      adults have true physical reactions to components of the vaccine or excipients. If this is
      true, then alternatives - such as the use of subunit vaccines or live attenuated nasal spray
      vaccines - might be expected to be better tolerated by these people.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Systemic adverse event
time frame: 7 days after each injection
description: Any systemic adverse event, self-reported
arm group label: Vaccine, then placebo
arm group type: Experimental
description: 1 injection of trivalent inactivated influenza vaccine, 0.5mL/dose, as approved for use in Canada for season of enrolment followed by 1 injection of normal saline placebo, 0.5mL/dose, 28 days later
arm group label: Placebo, then vaccine
arm group type: Experimental
description: 1 injection of normal saline placebo, 0.5mL/dose followed by 1 injection of trivalent inactivated influenza vaccine, 0.5mL/dose, as approved for use in Canada for season of enrolment, 28 days later
intervention type: Biological
intervention name: Vaccine
description: Licensed trivalent inactivated influenza vaccine
arm group label: Placebo, then vaccine
arm group label: Vaccine, then placebo
other name: Trivalent inactivated influenza vaccine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 69 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Allison J McGeer, MD
role: Principal Investigator
affiliation: MOUNT SINAI HOSPITAL
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Influenza, Human
mesh term: Vaccines
submitted: August 16, 2019
returned: September 18, 2019