<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/NCT01666782</url>
  </required_header>
  <id_info>
    <org_study_id>CIC 1336-B12-1</org_study_id>
    <nct_id>NCT01666782</nct_id>
  </id_info>
  <brief_title>Study Comparing High-Dose Flu Vaccine to Standard Vaccine in Cancer Patients Less Than 65 Receiving Chemotherapy</brief_title>
  <acronym>IMMUNE</acronym>
  <official_title>A Randomized Pilot Study Comparing High-Dose Influenza Vaccine to Standard-Dose Influenza Vaccine in Adult Oncology Patients Less Than 65 Years Receiving Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Saad Jamshed MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sanofi</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Rochester General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The safety and immunogenicity of high dose influenza vaccine has not been studied in young&#xD;
      patients receiving chemotherapy. This study will evaluate and compare the immunogenicity and&#xD;
      safety of high dose influenza to standard dose influenza vaccine in adult oncology patients&#xD;
      who are younger than 65 years old receiving chemotherapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <phase>Phase 2</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>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Geometric Mean Titer (GMT) of High-dose Influenza Vaccine vs the Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Who Are Less Than 65 Years Old.</measure>
    <time_frame>Baseline and 28 days</time_frame>
    <description>Measure Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) immunogenicity of high-dose (HD) and standard dose (SD) vaccine before and after vaccination at day 28.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Seroprotection Rate of High-dose Influenza Vaccine vs Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old.</measure>
    <time_frame>28 days</time_frame>
    <description>Seroprotection rate was defined as the percentage of patients with a HAI GMT of at least 1:40 28 days after vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Seroconversion Rate of High-dose Influenza Vaccine Versus Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old.</measure>
    <time_frame>Baseline and 28 days</time_frame>
    <description>Seroconversion rate was defined as the percentage of patients with a greater than or equal to 4-fold increase in HAI titer 28 days after vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate and Compare the Local Solicited Adverse Events to Both Vaccines.</measure>
    <time_frame>7 days</time_frame>
    <description>Local solicited adverse events, standard-dose (SD) vaccine and high-dose (HD) vaccine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate and Compare the Systemic Solicited Adverse Events to Both Vaccines.</measure>
    <time_frame>7 days</time_frame>
    <description>Systemic solicited adverse events, standard-dose (SD) vaccine and high-dose (HD) vaccine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate and Compare the Local and Systemic Unsolicited Adverse Events to Both Vaccines.</measure>
    <time_frame>28 days</time_frame>
    <description>Unsolicited adverse events occurring in more than one patient, standard-dose (SD) vaccine and high-dose (HD) vaccine</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">105</enrollment>
  <condition>Cancer</condition>
  <condition>Influenza Viral Infections</condition>
  <arm_group>
    <arm_group_label>High-Dose Influenza Vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Trivalent Influenza Vaccine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Standard Trivalent Influenza Vaccine</intervention_name>
    <description>Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.</description>
    <arm_group_label>Standard Trivalent Influenza Vaccine</arm_group_label>
    <other_name>Fluzone</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>High-Dose Influenza Vaccine</intervention_name>
    <description>Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.</description>
    <arm_group_label>High-Dose Influenza Vaccine</arm_group_label>
    <other_name>Fluzone High-Dose</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 18 years old to less than 65 years old&#xD;
&#xD;
          2. Subjects with malignancy must be receiving chemotherapy&#xD;
&#xD;
          3. Medically stable&#xD;
&#xD;
          4. Able to understand and willingness to sign a written informed consent&#xD;
&#xD;
          5. Able to comply with study procedures&#xD;
&#xD;
          6. Life expectancy of more than 3 months&#xD;
&#xD;
          7. Adequate organ function:&#xD;
&#xD;
               -  ANC &gt;1000/mm3&#xD;
&#xD;
               -  Platelet &gt;100,000/uL&#xD;
&#xD;
               -  Creatinine &lt;2 mg/dL&#xD;
&#xD;
               -  AST and ALT &lt;3 times the ULN&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Allergy to eggs&#xD;
&#xD;
          2. Prior allergy to Influenza Vaccine&#xD;
&#xD;
          3. History of Guillain-Barre Syndrome&#xD;
&#xD;
          4. Current febrile illness&#xD;
&#xD;
          5. Other immunosuppressive disease (recipients of solid organ transplant, uncontrolled&#xD;
             HIV)&#xD;
&#xD;
          6. Autologous or Allogenic Stem Cell Transplant with in a year&#xD;
&#xD;
          7. Current immunotherapy or immunochemotherapy in the last 6 months (rituximab or&#xD;
             ofatumumab)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Saad Jamshed, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rochester General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rochester General Hospital</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14621</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lipson Cancer Center Linden Oaks Medical Campus</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14625</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <results_first_submitted>January 29, 2016</results_first_submitted>
  <results_first_submitted_qc>April 15, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">May 24, 2016</results_first_posted>
  <last_update_submitted>May 23, 2016</last_update_submitted>
  <last_update_submitted_qc>May 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 24, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Rochester General Hospital</investigator_affiliation>
    <investigator_full_name>Saad Jamshed MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Influenza vaccine</keyword>
  <keyword>Oncology</keyword>
  <keyword>Chemotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
    <mesh_term>Virus Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaccines</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>105 patients were enrolled but only 100 had evaluable data. 4 patients received a vaccination both in years 1 and 2 of the study- only year 1 results were included in the analysis. 1 additional patient was excluded from the efficacy analysis when it was revealed he had received a second vaccination in the same season.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>High-Dose Influenza Vaccine</title>
          <description>High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.</description>
        </group>
        <group group_id="P2">
          <title>Standard Trivalent Influenza Vaccine</title>
          <description>Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="54"/>
                <participants group_id="P2" count="51"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Received 2 doses of vaccine</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Enrolled both years; year 1 data used</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>High-Dose Influenza Vaccine</title>
          <description>High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.</description>
        </group>
        <group group_id="B2">
          <title>Standard Trivalent Influenza Vaccine</title>
          <description>Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="50"/>
            <count group_id="B2" value="50"/>
            <count group_id="B3" value="100"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53.94" spread="7.16"/>
                    <measurement group_id="B2" value="52.9" spread="7.95"/>
                    <measurement group_id="B3" value="53.4" spread="7.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="57"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Geometric Mean Titer (GMT) of High-dose Influenza Vaccine vs the Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Who Are Less Than 65 Years Old.</title>
        <description>Measure Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) immunogenicity of high-dose (HD) and standard dose (SD) vaccine before and after vaccination at day 28.</description>
        <time_frame>Baseline and 28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>High-Dose Influenza Vaccine</title>
            <description>High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.</description>
          </group>
          <group group_id="O2">
            <title>Standard Trivalent Influenza Vaccine</title>
            <description>Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.</description>
          </group>
        </group_list>
        <measure>
          <title>The Geometric Mean Titer (GMT) of High-dose Influenza Vaccine vs the Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Who Are Less Than 65 Years Old.</title>
          <description>Measure Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) immunogenicity of high-dose (HD) and standard dose (SD) vaccine before and after vaccination at day 28.</description>
          <units>titers</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre Vaccination H1N1 Antigen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="125.2" lower_limit="74.6" upper_limit="175.8"/>
                    <measurement group_id="O2" value="266.1" lower_limit="52.1" upper_limit="480.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pre Vaccination H3N2 Antigen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="134.1" lower_limit="54.9" upper_limit="213.2"/>
                    <measurement group_id="O2" value="143.2" lower_limit="64.5" upper_limit="221.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pre Vaccination B Antigen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.4" lower_limit="20.4" upper_limit="42.3"/>
                    <measurement group_id="O2" value="54.7" lower_limit="31.6" upper_limit="77.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Vaccination H1N1 Antigen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1350.1" lower_limit="819.8" upper_limit="1880.4"/>
                    <measurement group_id="O2" value="979.1" lower_limit="609.1" upper_limit="1349.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Vaccination H3N2 Antigen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1143.4" lower_limit="739.6" upper_limit="1547.3"/>
                    <measurement group_id="O2" value="811.2" lower_limit="401.2" upper_limit="1221.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Vaccination B Antigen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="351.6" lower_limit="215.6" upper_limit="487.7"/>
                    <measurement group_id="O2" value="228" lower_limit="129.9" upper_limit="326.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Seroprotection Rate of High-dose Influenza Vaccine vs Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old.</title>
        <description>Seroprotection rate was defined as the percentage of patients with a HAI GMT of at least 1:40 28 days after vaccination.</description>
        <time_frame>28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>High-Dose Influenza Vaccine</title>
            <description>High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.</description>
          </group>
          <group group_id="O2">
            <title>Standard Trivalent Influenza Vaccine</title>
            <description>Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.</description>
          </group>
        </group_list>
        <measure>
          <title>The Seroprotection Rate of High-dose Influenza Vaccine vs Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old.</title>
          <description>Seroprotection rate was defined as the percentage of patients with a HAI GMT of at least 1:40 28 days after vaccination.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H1N1 Antigen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96"/>
                    <measurement group_id="O2" value="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2 Antigen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96"/>
                    <measurement group_id="O2" value="96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B Antigen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88"/>
                    <measurement group_id="O2" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Seroconversion Rate of High-dose Influenza Vaccine Versus Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old.</title>
        <description>Seroconversion rate was defined as the percentage of patients with a greater than or equal to 4-fold increase in HAI titer 28 days after vaccination.</description>
        <time_frame>Baseline and 28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>High-Dose Influenza Vaccine</title>
            <description>High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.</description>
          </group>
          <group group_id="O2">
            <title>Standard Trivalent Influenza Vaccine</title>
            <description>Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.</description>
          </group>
        </group_list>
        <measure>
          <title>The Seroconversion Rate of High-dose Influenza Vaccine Versus Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old.</title>
          <description>Seroconversion rate was defined as the percentage of patients with a greater than or equal to 4-fold increase in HAI titer 28 days after vaccination.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H1N1 Antigen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72"/>
                    <measurement group_id="O2" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2 Antigen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80"/>
                    <measurement group_id="O2" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B Antigen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80"/>
                    <measurement group_id="O2" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Evaluate and Compare the Local Solicited Adverse Events to Both Vaccines.</title>
        <description>Local solicited adverse events, standard-dose (SD) vaccine and high-dose (HD) vaccine</description>
        <time_frame>7 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>High-Dose Influenza Vaccine</title>
            <description>High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.</description>
          </group>
          <group group_id="O2">
            <title>Standard Trivalent Influenza Vaccine</title>
            <description>Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluate and Compare the Local Solicited Adverse Events to Both Vaccines.</title>
          <description>Local solicited adverse events, standard-dose (SD) vaccine and high-dose (HD) vaccine</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Injection site pain- mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site pain-moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site swelling-mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site swelling-moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site redness-mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site redness-moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site itching-mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site itching-moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Evaluate and Compare the Systemic Solicited Adverse Events to Both Vaccines.</title>
        <description>Systemic solicited adverse events, standard-dose (SD) vaccine and high-dose (HD) vaccine</description>
        <time_frame>7 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>High-Dose Influenza Vaccine</title>
            <description>High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.</description>
          </group>
          <group group_id="O2">
            <title>Standard Trivalent Influenza Vaccine</title>
            <description>Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluate and Compare the Systemic Solicited Adverse Events to Both Vaccines.</title>
          <description>Systemic solicited adverse events, standard-dose (SD) vaccine and high-dose (HD) vaccine</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Fever-mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever-moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever-severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache-mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache-moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache-severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Malaise-mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Malaise-moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Malaise-severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia-mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia-moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia-severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Evaluate and Compare the Local and Systemic Unsolicited Adverse Events to Both Vaccines.</title>
        <description>Unsolicited adverse events occurring in more than one patient, standard-dose (SD) vaccine and high-dose (HD) vaccine</description>
        <time_frame>28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>High-Dose Influenza Vaccine</title>
            <description>High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.</description>
          </group>
          <group group_id="O2">
            <title>Standard Trivalent Influenza Vaccine</title>
            <description>Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluate and Compare the Local and Systemic Unsolicited Adverse Events to Both Vaccines.</title>
          <description>Unsolicited adverse events occurring in more than one patient, standard-dose (SD) vaccine and high-dose (HD) vaccine</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Fatigue: Grade 1 or 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue: Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nausea: Grade 1 or 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nausea: Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vomiting: Grade 1 or 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vomiting: Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>28 +/- 7 days post-vaccination</time_frame>
      <group_list>
        <group group_id="E1">
          <title>High-Dose Influenza Vaccine</title>
          <description>High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.</description>
        </group>
        <group group_id="E2">
          <title>Standard Trivalent Influenza Vaccine</title>
          <description>Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (10.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="50"/>
                <counts group_id="E2" events="11" subjects_affected="11" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title vocab="NCIC CTG v4.0">Malaise</sub_title>
                <counts group_id="E1" events="26" subjects_affected="26" subjects_at_risk="50"/>
                <counts group_id="E2" events="22" subjects_affected="22" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Injection-site pain</sub_title>
                <counts group_id="E1" events="16" subjects_affected="16" subjects_at_risk="50"/>
                <counts group_id="E2" events="11" subjects_affected="11" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Injection-site swelling</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="50"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Injection-site itching</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="50"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Injection-site redness</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="50"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="22" subjects_affected="22" subjects_at_risk="50"/>
                <counts group_id="E2" events="16" subjects_affected="16" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="16" subjects_affected="16" subjects_at_risk="50"/>
                <counts group_id="E2" events="16" subjects_affected="16" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>All research data and results generated during the course of or as a result of the Research Project shall be the property of Investigator and/or institution. Sanofi Pasteur will have access to the full set of data collected during the Research Project. The text of any manuscript, abstract or oral presentation based on this Research Project will be provided to Sanofi Pasteur at least 30 days prior to submission to a journal, a congress, or prior to an oral presentation.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Saad Jamshed, MD</name_or_title>
      <organization>Rochester General Hospital</organization>
      <phone>585-922-4020</phone>
      <email>Saad.Jamshed@rochesterregional.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01666782
org study id: CIC 1336-B12-1
nct id: NCT01666782
lead sponsor: 
collaborator: 
has dmc: No
The safety and immunogenicity of high dose influenza vaccine has not been studied in young
      patients receiving chemotherapy. This study will evaluate and compare the immunogenicity and
      safety of high dose influenza to standard dose influenza vaccine in adult oncology patients
      who are younger than 65 years old receiving chemotherapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Care Provider)
measure: The Geometric Mean Titer (GMT) of High-dose Influenza Vaccine vs the Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Who Are Less Than 65 Years Old.
time frame: Baseline and 28 days
description: Measure Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) immunogenicity of high-dose (HD) and standard dose (SD) vaccine before and after vaccination at day 28.
measure: The Seroprotection Rate of High-dose Influenza Vaccine vs Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old.
time frame: 28 days
description: Seroprotection rate was defined as the percentage of patients with a HAI GMT of at least 1:40 28 days after vaccination.
measure: The Seroconversion Rate of High-dose Influenza Vaccine Versus Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old.
time frame: Baseline and 28 days
description: Seroconversion rate was defined as the percentage of patients with a greater than or equal to 4-fold increase in HAI titer 28 days after vaccination.
measure: Evaluate and Compare the Local Solicited Adverse Events to Both Vaccines.
time frame: 7 days
description: Local solicited adverse events, standard-dose (SD) vaccine and high-dose (HD) vaccine
measure: Evaluate and Compare the Systemic Solicited Adverse Events to Both Vaccines.
time frame: 7 days
description: Systemic solicited adverse events, standard-dose (SD) vaccine and high-dose (HD) vaccine
measure: Evaluate and Compare the Local and Systemic Unsolicited Adverse Events to Both Vaccines.
time frame: 28 days
description: Unsolicited adverse events occurring in more than one patient, standard-dose (SD) vaccine and high-dose (HD) vaccine
arm group label: High-Dose Influenza Vaccine
arm group type: Experimental
arm group label: Standard Trivalent Influenza Vaccine
arm group type: Active Comparator
intervention type: Biological
intervention name: Standard Trivalent Influenza Vaccine
description: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
arm group label: Standard Trivalent Influenza Vaccine
other name: Fluzone
intervention type: Biological
intervention name: High-Dose Influenza Vaccine
description: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
arm group label: High-Dose Influenza Vaccine
other name: Fluzone High-Dose
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: No
last name: Saad Jamshed, MD
role: Principal Investigator
affiliation: Rochester General Hospital
facility: 
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Rochester General Hospital
investigator full name: Saad Jamshed MD
investigator title: Principal Investigator
mesh term: Influenza, Human
mesh term: Virus Diseases
mesh term: Vaccines
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 