<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/NCT01691339</url>
  </required_header>
  <id_info>
    <org_study_id>GRC50</org_study_id>
    <secondary_id>U 1111-1124-8310</secondary_id>
    <nct_id>NCT01691339</nct_id>
  </id_info>
  <brief_title>Study of Fluzone® Influenza Virus Vaccines 2012-2013 Formulation Among Adults.</brief_title>
  <official_title>Safety and Immunogenicity Among Adults of Fluzone®, Influenza Virus Vaccines 2012-2013 Formulation (Intradermal and Intramuscular Route)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sanofi Pasteur, a Sanofi Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sanofi</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to evaluate the safety and immunogenicity of Fluzone vaccine (18&#xD;
      years to &lt;65 years of age and ≥ 65 years of age), Fluzone Intradermal vaccine (18 years to&#xD;
      &lt;65 years of age), and Fluzone High-Dose vaccine (≥ 65 years of age).&#xD;
&#xD;
      Primary Objective:&#xD;
&#xD;
        -  To describe the safety of the 2012 - 2013 formulation of Fluzone and Fluzone Intradermal&#xD;
           vaccines in adults 18 to &lt; 65 years of age and the safety of the 2012 - 2013 formulation&#xD;
           of Fluzone and Fluzone High-Dose vaccines in adults ≥ 65 years of age.&#xD;
&#xD;
      Observational Objectives:&#xD;
&#xD;
        -  To describe the immunogenicity of the 2012 - 2013 formulation of Fluzone and Fluzone&#xD;
           Intradermal vaccines in adults 18 to &lt; 65 years of age and the immunogenicity of the&#xD;
           2012 - 2013 formulation of Fluzone and Fluzone High-Dose vaccines in adults ≥ 65 years&#xD;
           of age.&#xD;
&#xD;
        -  To evaluate the compliance, in terms of immunogenicity, of each study vaccine (Fluzone,&#xD;
           Fluzone Intradermal, and Fluzone High-Dose) in the applicable age group with the&#xD;
           requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance&#xD;
           (NfG) CPMP/BWP/214/96.&#xD;
&#xD;
        -  To submit remaining available sera from subjects given Fluzone vaccine to the Center for&#xD;
           Biologics Evaluation and Research (CBER) for further analysis by the World Health&#xD;
           Organization (WHO), the Centers for Disease Control and Prevention (CDC), and the Food&#xD;
           and Drug Administration (FDA) to support selection and recommendation of strains for&#xD;
           subsequent years' influenza vaccines.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants 18 to &lt; 65 years of age will be randomized to receive a dose of either Fluzone&#xD;
      or Fluzone Intradermal vaccine and participants ≥ 65 years of age will be randomized to&#xD;
      receive a dose of Fluzone or Fluzone High-Dose vaccine. All participants will be followed up&#xD;
      for safety and immunogenicity. The duration of participation in the trial will be&#xD;
      approximately 21 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">November 2012</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine</measure>
    <time_frame>Day 0 up to Day 7 post-vaccination</time_frame>
    <description>Solicited injection site: Pain, Erythema, Swelling, Induration, and Ecchymosis; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering.&#xD;
Grade 3 injection site: Pain - Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis - &gt;100 mm. Grade 3 systemic reactions: Fever ≥39.0°C; Headache, Malaise, Myalgia, and Shivering - significant, prevents daily activity.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine</measure>
    <time_frame>Day 0 (pre-vaccination) up to Day 21 post-vaccination</time_frame>
    <description>Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine</measure>
    <time_frame>Day 0 (pre-vaccination) and Day 21 post-vaccination</time_frame>
    <description>Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay. Seroprotection was defined as a pre-vaccination or a post-vaccination titer ≥ 40 (l/dil).</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Adult Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine</measure>
    <time_frame>Day 0 (pre-vaccination) and Day 21 post-vaccination</time_frame>
    <description>Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay. Seroconversion was defined as either a pre-vaccination titer &lt; 10 (1/dil) and a post-vaccination titer ≥ 40 (1/dil), or a pre-vaccination titer ≥ 10 (1/dil) and a ≥ 4-fold increase in post-vaccination titer.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With Influenza Antibody Titers of &lt;1:10 Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine</measure>
    <time_frame>Day 0 (pre-vaccination) and Day 21 post-vaccination</time_frame>
    <description>Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay to determine pre-vaccination and post-vaccination titers of &lt;1:10.</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>Fluzone vaccine (Group 1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adults 18 to &lt; 65 years of age randomized to receive one dose of Fluzone vaccine intramuscularly</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fluzone Intradermal vaccine (Group 2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adults 18 to &lt; 65 years of age randomized to receive one dose of Fluzone Intradermal vaccine intradermally</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fluzone vaccine (Group 3)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adults ≥ 65 years of age randomized to receive one dose of Fluzone vaccine intramuscularly</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fluzone High-Dose Vaccine (Group 4)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Adults ≥ 65 years of age randomized to receive one dose of Fluzone High-Dose vaccine intramuscularly</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Influenza Virus Vaccine: Fluzone® 2012-2013 Formulation</intervention_name>
    <description>0.5 mL, Intramuscular</description>
    <arm_group_label>Fluzone vaccine (Group 1)</arm_group_label>
    <other_name>Fluzone® (2012-2013 Formulation)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Influenza Virus Vaccine: Fluzone® Intradermal 2012-2013 Formulation</intervention_name>
    <description>0.1 mL, Intradermal</description>
    <arm_group_label>Fluzone Intradermal vaccine (Group 2)</arm_group_label>
    <other_name>Fluzone® Intradermal (2012-2013 Formulation)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Influenza Virus Vaccine: Fluzone® 2012-2013 Formulation</intervention_name>
    <description>0.5 mL, Intramuscular</description>
    <arm_group_label>Fluzone vaccine (Group 3)</arm_group_label>
    <other_name>Fluzone® (2012-2013 Formulation)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Influenza Virus Vaccine: Fluzone® High-Dose 2012-2013 Formulation</intervention_name>
    <description>0.5 mL, Intramuscular</description>
    <arm_group_label>Fluzone High-Dose Vaccine (Group 4)</arm_group_label>
    <other_name>Fluzone® High-Dose (2012-2013 Formulation)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is ≥ 18 years of age on the day of inclusion&#xD;
&#xD;
          -  Informed consent form has been signed and dated&#xD;
&#xD;
          -  Able to attend all scheduled visits and to comply with all trial procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of serious adverse reaction to any influenza vaccine&#xD;
&#xD;
          -  Receipt of any vaccine within 30 days before receiving study vaccine, or plans to&#xD;
             receive another vaccine before Visit 2&#xD;
&#xD;
          -  Participation in another interventional clinical trial investigating a vaccine, drug,&#xD;
             medical device, or medical procedure in the 30 days preceding the first study&#xD;
             vaccination or during the course of the study, unless no intervention for the other&#xD;
             study occurred within the 30 days prior to the first study vaccination and none are&#xD;
             planned before the subject would complete safety surveillance for the present study&#xD;
&#xD;
          -  Thrombocytopenia, which may be a contraindication for intramuscular vaccination, at&#xD;
             the discretion of the Investigator&#xD;
&#xD;
          -  Prior vaccination with any 2012 - 2013 formulation of influenza vaccine&#xD;
&#xD;
          -  Known systemic hypersensitivity to eggs, chicken proteins, latex, or any of the&#xD;
             vaccine components, or a history of a life-threatening reaction to Fluzone, Fluzone&#xD;
             Intradermal, or Fluzone High-Dose vaccine or to a vaccine containing any of the same&#xD;
             substances (the complete list of vaccine components is included in the Prescribing&#xD;
             Information)&#xD;
&#xD;
          -  Receipt of immune globulins, blood, or blood-derived products in the past 3 months&#xD;
&#xD;
          -  Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion,&#xD;
             which may be a contraindication for intramuscular vaccination, at the discretion of&#xD;
             the Investigator&#xD;
&#xD;
          -  Subject is pregnant, or lactating, or of childbearing potential (to be considered of&#xD;
             non-childbearing potential, a female must be pre-menarche or post-menopausal for at&#xD;
             least 1 year, surgically sterile, or using an effective method of contraception or&#xD;
             abstinence from at least 4 weeks prior to vaccination and until at least 4 weeks after&#xD;
             vaccination)&#xD;
&#xD;
          -  Any condition that in the opinion of the Investigator would pose a health risk to the&#xD;
             subject if enrolled or could interfere with the evaluation of the vaccine&#xD;
&#xD;
          -  Personal history of Guillain-Barré syndrome&#xD;
&#xD;
          -  Known or suspected congenital or acquired immunodeficiency; or receipt of&#xD;
             immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy,&#xD;
             within the preceding 6 months; or long-term systemic corticosteroid therapy&#xD;
             (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)&#xD;
&#xD;
          -  Chronic illness that, in the opinion of the Investigator, is at a stage where it might&#xD;
             interfere with trial conduct or completion&#xD;
&#xD;
          -  Seropositivity for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C, as&#xD;
             reported by the subject&#xD;
&#xD;
          -  Deprived of freedom by an administrative or court order, or in an emergency setting,&#xD;
             or hospitalized involuntarily&#xD;
&#xD;
          -  Current alcohol or drug addiction that, in the opinion of the Investigator, might&#xD;
             interfere with the ability to comply with trial procedures&#xD;
&#xD;
          -  Moderate or severe acute illness/infection (according to Investigator judgment) or&#xD;
             febrile illness (temperature ≥ 100.4°F) on the day of vaccination. A prospective&#xD;
             subject should not be included in the study until the condition has resolved or the&#xD;
             febrile event has subsided&#xD;
&#xD;
          -  Identified as an Investigator or employee of the Investigator or study center with&#xD;
             direct involvement in the proposed study, or identified as an immediate family member&#xD;
             (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with&#xD;
             direct involvement in the proposed study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Sanofi Pasteur Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33432</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>South Miami</city>
        <state>Florida</state>
        <zip>33143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Council Bluffs</city>
        <state>Iowa</state>
        <zip>51503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Metairie</city>
        <state>Louisiana</state>
        <zip>70006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.sanofipasteur.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>August 2013</verification_date>
  <study_first_submitted>September 19, 2012</study_first_submitted>
  <study_first_submitted_qc>September 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <results_first_submitted>August 29, 2013</results_first_submitted>
  <results_first_submitted_qc>August 29, 2013</results_first_submitted_qc>
  <results_first_posted type="Estimate">November 3, 2013</results_first_posted>
  <last_update_submitted>August 29, 2013</last_update_submitted>
  <last_update_submitted_qc>August 29, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 3, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Influenza</keyword>
  <keyword>Influenza virus vaccine</keyword>
  <keyword>Fluzone® (Influenza Virus Vaccine) 2012-2013 Formulation</keyword>
  <keyword>Fluzone® High-Dose (Influenza Virus Vaccine) 2012-2013 Formulation</keyword>
  <keyword>Trivalent Inactivated Influenza Vaccine</keyword>
  <keyword>Fluzone® Intradermal (Influenza Virus Vaccine) 2012-2013 Formulation</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>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study participants were enrolled from 19 through 27 September 2012 at 4 clinic centers in the United States.</recruitment_details>
      <pre_assignment_details>A total of 200 participants who met all of the inclusion and none of the exclusion criteria were randomized and vaccinated in this study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Fluzone® Vaccine (Group 1)</title>
          <description>Adults 18 to &lt; 65 years of age received one dose of Fluzone vaccine intramuscularly</description>
        </group>
        <group group_id="P2">
          <title>Fluzone® Intradermal Vaccine (Group 2)</title>
          <description>Adults 18 to &lt; 65 years of age received one dose of Fluzone Intradermal vaccine intradermally</description>
        </group>
        <group group_id="P3">
          <title>Fluzone® Vaccine (Group 3)</title>
          <description>Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly</description>
        </group>
        <group group_id="P4">
          <title>Fluzone® High-Dose Vaccine (Group 4)</title>
          <description>Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="50"/>
                <participants group_id="P3" count="51"/>
                <participants group_id="P4" count="49"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="50"/>
                <participants group_id="P3" count="51"/>
                <participants group_id="P4" count="49"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Fluzone® Vaccine (Group 1)</title>
          <description>Adults 18 to &lt; 65 years of age received one dose of Fluzone vaccine intramuscularly</description>
        </group>
        <group group_id="B2">
          <title>Fluzone® Intradermal Vaccine (Group 2)</title>
          <description>Adults 18 to &lt; 65 years of age received one dose of Fluzone Intradermal vaccine intradermally</description>
        </group>
        <group group_id="B3">
          <title>Fluzone® Vaccine (Group 3)</title>
          <description>Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly</description>
        </group>
        <group group_id="B4">
          <title>Fluzone® High-Dose Vaccine (Group 4)</title>
          <description>Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly</description>
        </group>
        <group group_id="B5">
          <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="51"/>
            <count group_id="B4" value="49"/>
            <count group_id="B5" value="200"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="100"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="51"/>
                    <measurement group_id="B4" value="49"/>
                    <measurement group_id="B5" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="43.4" spread="13.6"/>
                    <measurement group_id="B2" value="40.5" spread="14.2"/>
                    <measurement group_id="B3" value="73.3" spread="5.7"/>
                    <measurement group_id="B4" value="72.2" spread="5.2"/>
                    <measurement group_id="B5" value="57.4" spread="18.7"/>
                  </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="29"/>
                    <measurement group_id="B3" value="32"/>
                    <measurement group_id="B4" value="35"/>
                    <measurement group_id="B5" value="127"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="19"/>
                    <measurement group_id="B4" value="14"/>
                    <measurement group_id="B5" value="73"/>
                  </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="51"/>
                    <measurement group_id="B4" value="49"/>
                    <measurement group_id="B5" value="200"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine</title>
        <description>Solicited injection site: Pain, Erythema, Swelling, Induration, and Ecchymosis; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering.&#xD;
Grade 3 injection site: Pain - Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis - &gt;100 mm. Grade 3 systemic reactions: Fever ≥39.0°C; Headache, Malaise, Myalgia, and Shivering - significant, prevents daily activity.</description>
        <time_frame>Day 0 up to Day 7 post-vaccination</time_frame>
        <population>Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluzone® Vaccine (Group 1)</title>
            <description>Adults 18 to &lt; 65 years of age received one dose of Fluzone vaccine intramuscularly</description>
          </group>
          <group group_id="O2">
            <title>Fluzone® Intradermal Vaccine (Group 2)</title>
            <description>Adults 18 to &lt; 65 years of age received one dose of Fluzone Intradermal vaccine intradermally</description>
          </group>
          <group group_id="O3">
            <title>Fluzone® Vaccine (Group 3)</title>
            <description>Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly</description>
          </group>
          <group group_id="O4">
            <title>Fluzone® High-Dose Vaccine (Group 4)</title>
            <description>Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine</title>
          <description>Solicited injection site: Pain, Erythema, Swelling, Induration, and Ecchymosis; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering.&#xD;
Grade 3 injection site: Pain - Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis - &gt;100 mm. Grade 3 systemic reactions: Fever ≥39.0°C; Headache, Malaise, Myalgia, and Shivering - significant, prevents daily activity.</description>
          <population>Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set.</population>
          <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 group_id="O3" value="51"/>
                <count group_id="O4" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Injection site Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="20"/>
                    <measurement group_id="O3" value="12"/>
                    <measurement group_id="O4" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Injection site Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site Erythema</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="16"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Injection site Erythema</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site Swelling</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Injection site Swelling</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site Induration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3Injection site Induration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site Ecchymosis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Injection site Ecchymosis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Fever</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Headache</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Malaise</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Malaise</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="13"/>
                    <measurement group_id="O4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Myalgia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Shivering</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Shivering</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine</title>
        <description>Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay.</description>
        <time_frame>Day 0 (pre-vaccination) up to Day 21 post-vaccination</time_frame>
        <population>Geometric mean titers against the influenza virus antigens were assessed in the Per-Protocol Analysis Set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluzone® Vaccine (Group 1)</title>
            <description>Adults 18 to &lt; 65 years of age received one dose of Fluzone vaccine intramuscularly</description>
          </group>
          <group group_id="O2">
            <title>Fluzone® Intradermal Vaccine (Group 2)</title>
            <description>Adults 18 to &lt; 65 years of age received one dose of Fluzone Intradermal vaccine intradermally</description>
          </group>
          <group group_id="O3">
            <title>Fluzone® Vaccine (Group 3)</title>
            <description>Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly</description>
          </group>
          <group group_id="O4">
            <title>Fluzone® High-Dose Vaccine (Group 4)</title>
            <description>Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine</title>
          <description>Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay.</description>
          <population>Geometric mean titers against the influenza virus antigens were assessed in the Per-Protocol Analysis Set.</population>
          <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="46"/>
                <count group_id="O2" value="47"/>
                <count group_id="O3" value="49"/>
                <count group_id="O4" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A/H1N1 (Pre-vaccination; N = 46, 46, 49, 46)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.3" lower_limit="17.5" upper_limit="45.6"/>
                    <measurement group_id="O2" value="30.7" lower_limit="18.3" upper_limit="51.7"/>
                    <measurement group_id="O3" value="58.6" lower_limit="37.5" upper_limit="91.6"/>
                    <measurement group_id="O4" value="81.8" lower_limit="50.2" upper_limit="133"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H1N1 (Post-vaccination; N = 46, 47, 49, 46)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1068" lower_limit="755" upper_limit="1512"/>
                    <measurement group_id="O2" value="1473" lower_limit="955" upper_limit="2269"/>
                    <measurement group_id="O3" value="246" lower_limit="177" upper_limit="343"/>
                    <measurement group_id="O4" value="369" lower_limit="266" upper_limit="513"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2 (Pre-vaccination; N = 46, 46, 49, 46)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.1" lower_limit="18.0" upper_limit="47.3"/>
                    <measurement group_id="O2" value="23.6" lower_limit="14.3" upper_limit="39.0"/>
                    <measurement group_id="O3" value="68.5" lower_limit="42.6" upper_limit="110"/>
                    <measurement group_id="O4" value="78.2" lower_limit="50.2" upper_limit="122"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2 (Post-vaccination; N = 45, 47, 49, 46)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="460" lower_limit="306" upper_limit="691"/>
                    <measurement group_id="O2" value="599" lower_limit="369" upper_limit="971"/>
                    <measurement group_id="O3" value="264" lower_limit="176" upper_limit="397"/>
                    <measurement group_id="O4" value="392" lower_limit="266" upper_limit="578"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B (Pre-vaccination; N = 46, 46, 49, 46)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.9" lower_limit="13.0" upper_limit="24.6"/>
                    <measurement group_id="O2" value="20.9" lower_limit="15.5" upper_limit="28.3"/>
                    <measurement group_id="O3" value="13.7" lower_limit="10.5" upper_limit="17.7"/>
                    <measurement group_id="O4" value="18.7" lower_limit="14.4" upper_limit="24.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B (Post-vaccination; N = 45, 47, 49, 46)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="169" lower_limit="131" upper_limit="218"/>
                    <measurement group_id="O2" value="129" lower_limit="91.1" upper_limit="183"/>
                    <measurement group_id="O3" value="35.2" lower_limit="25.8" upper_limit="48.1"/>
                    <measurement group_id="O4" value="60.1" lower_limit="43.8" upper_limit="82.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine</title>
        <description>Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay. Seroprotection was defined as a pre-vaccination or a post-vaccination titer ≥ 40 (l/dil).</description>
        <time_frame>Day 0 (pre-vaccination) and Day 21 post-vaccination</time_frame>
        <population>Seroprotection against influenza vaccine antigens were assessed in the Per-Protocol Analysis Set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluzone® Vaccine (Group 1)</title>
            <description>Adults 18 to &lt; 65 years of age received one dose of Fluzone vaccine intramuscularly</description>
          </group>
          <group group_id="O2">
            <title>Fluzone® Intradermal Vaccine (Group 2)</title>
            <description>Adults 18 to &lt; 65 years of age received one dose of Fluzone Intradermal vaccine intradermally</description>
          </group>
          <group group_id="O3">
            <title>Fluzone® Vaccine (Group 3)</title>
            <description>Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly</description>
          </group>
          <group group_id="O4">
            <title>Fluzone® High-Dose Vaccine (Group 4)</title>
            <description>Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine</title>
          <description>Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay. Seroprotection was defined as a pre-vaccination or a post-vaccination titer ≥ 40 (l/dil).</description>
          <population>Seroprotection against influenza vaccine antigens were assessed in the Per-Protocol Analysis Set.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="47"/>
                <count group_id="O3" value="49"/>
                <count group_id="O4" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A/H1N1 (Pre-vaccination; N = 46, 46, 49, 46)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22" lower_limit="32.9" upper_limit="63.1"/>
                    <measurement group_id="O2" value="23" lower_limit="34.9" upper_limit="65.1"/>
                    <measurement group_id="O3" value="32" lower_limit="50.4" upper_limit="78.3"/>
                    <measurement group_id="O4" value="33" lower_limit="56.5" upper_limit="84.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H1N1 (Post-vaccination; N = 46, 47, 49, 46)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46" lower_limit="92.3" upper_limit="100.0"/>
                    <measurement group_id="O2" value="46" lower_limit="88.7" upper_limit="99.9"/>
                    <measurement group_id="O3" value="49" lower_limit="92.7" upper_limit="100.0"/>
                    <measurement group_id="O4" value="45" lower_limit="88.5" upper_limit="99.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2 (Pre-vaccination; N = 46, 46, 49, 46)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22" lower_limit="32.9" upper_limit="63.1"/>
                    <measurement group_id="O2" value="15" lower_limit="19.5" upper_limit="48.0"/>
                    <measurement group_id="O3" value="33" lower_limit="52.5" upper_limit="80.1"/>
                    <measurement group_id="O4" value="31" lower_limit="52.0" upper_limit="80.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2 (Post-vaccination; N = 45, 47, 49, 46)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44" lower_limit="88.2" upper_limit="99.9"/>
                    <measurement group_id="O2" value="45" lower_limit="85.5" upper_limit="99.5"/>
                    <measurement group_id="O3" value="46" lower_limit="83.1" upper_limit="98.7"/>
                    <measurement group_id="O4" value="45" lower_limit="88.5" upper_limit="99.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B (Pre-vaccination; N = 46, 46, 49, 46)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9" lower_limit="9.4" upper_limit="33.9"/>
                    <measurement group_id="O2" value="15" lower_limit="19.5" upper_limit="48.0"/>
                    <measurement group_id="O3" value="8" lower_limit="7.3" upper_limit="29.7"/>
                    <measurement group_id="O4" value="13" lower_limit="16.0" upper_limit="43.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B (Post-vaccination; N = 45, 47, 49, 46)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45" lower_limit="92.1" upper_limit="100.0"/>
                    <measurement group_id="O2" value="40" lower_limit="71.7" upper_limit="93.8"/>
                    <measurement group_id="O3" value="26" lower_limit="38.3" upper_limit="67.5"/>
                    <measurement group_id="O4" value="33" lower_limit="56.5" upper_limit="84.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Adult Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine</title>
        <description>Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay. Seroconversion was defined as either a pre-vaccination titer &lt; 10 (1/dil) and a post-vaccination titer ≥ 40 (1/dil), or a pre-vaccination titer ≥ 10 (1/dil) and a ≥ 4-fold increase in post-vaccination titer.</description>
        <time_frame>Day 0 (pre-vaccination) and Day 21 post-vaccination</time_frame>
        <population>Seroconversion to the influenza virus vaccine antigens was assessed in the Per-Protocol Analysis Set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluzone® Vaccine (Group 1)</title>
            <description>Adults 18 to &lt; 65 years of age received one dose of Fluzone vaccine intramuscularly</description>
          </group>
          <group group_id="O2">
            <title>Fluzone® Intradermal Vaccine (Group 2)</title>
            <description>Adults 18 to &lt; 65 years of age received one dose of Fluzone Intradermal vaccine intradermally</description>
          </group>
          <group group_id="O3">
            <title>Fluzone® Vaccine (Group 3)</title>
            <description>Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly</description>
          </group>
          <group group_id="O4">
            <title>Fluzone® High-Dose Vaccine (Group 4)</title>
            <description>Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Adult Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine</title>
          <description>Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay. Seroconversion was defined as either a pre-vaccination titer &lt; 10 (1/dil) and a post-vaccination titer ≥ 40 (1/dil), or a pre-vaccination titer ≥ 10 (1/dil) and a ≥ 4-fold increase in post-vaccination titer.</description>
          <population>Seroconversion to the influenza virus vaccine antigens was assessed in the Per-Protocol Analysis Set.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="47"/>
                <count group_id="O3" value="49"/>
                <count group_id="O4" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A/H1N1 (N = 46, 46, 49, 46)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43" lower_limit="82.1" upper_limit="98.6"/>
                    <measurement group_id="O2" value="43" lower_limit="82.1" upper_limit="98.6"/>
                    <measurement group_id="O3" value="21" lower_limit="28.8" upper_limit="57.8"/>
                    <measurement group_id="O4" value="26" lower_limit="41.1" upper_limit="71.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2 (N = 45, 46, 49, 46)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34" lower_limit="60.5" upper_limit="87.1"/>
                    <measurement group_id="O2" value="39" lower_limit="71.1" upper_limit="93.7"/>
                    <measurement group_id="O3" value="19" lower_limit="25.2" upper_limit="53.8"/>
                    <measurement group_id="O4" value="28" lower_limit="45.4" upper_limit="74.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B (N = 45, 46, 49, 46)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36" lower_limit="65.4" upper_limit="90.4"/>
                    <measurement group_id="O2" value="33" lower_limit="56.5" upper_limit="84.0"/>
                    <measurement group_id="O3" value="13" lower_limit="14.9" upper_limit="41.1"/>
                    <measurement group_id="O4" value="16" lower_limit="21.4" upper_limit="50.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Influenza Antibody Titers of &lt;1:10 Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine</title>
        <description>Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay to determine pre-vaccination and post-vaccination titers of &lt;1:10.</description>
        <time_frame>Day 0 (pre-vaccination) and Day 21 post-vaccination</time_frame>
        <population>Antibody responses to the influenza vaccine antigens were assessed in the Per-Protocol Analysis Set.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluzone® Vaccine (Group 1)</title>
            <description>Adults 18 to &lt; 65 years of age received one dose of Fluzone vaccine intramuscularly</description>
          </group>
          <group group_id="O2">
            <title>Fluzone® Intradermal Vaccine (Group 2)</title>
            <description>Adults 18 to &lt; 65 years of age received one dose of Fluzone Intradermal vaccine intradermally</description>
          </group>
          <group group_id="O3">
            <title>Fluzone® Vaccine (Group 3)</title>
            <description>Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly</description>
          </group>
          <group group_id="O4">
            <title>Fluzone® High-Dose Vaccine (Group 4)</title>
            <description>Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Influenza Antibody Titers of &lt;1:10 Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine</title>
          <description>Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay to determine pre-vaccination and post-vaccination titers of &lt;1:10.</description>
          <population>Antibody responses to the influenza vaccine antigens were assessed in the Per-Protocol Analysis Set.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="47"/>
                <count group_id="O3" value="49"/>
                <count group_id="O4" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A/H1N1 (Pre-vaccination; N = 46, 46, 49, 46)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18" lower_limit="25.1" upper_limit="54.6"/>
                    <measurement group_id="O2" value="17" lower_limit="23.2" upper_limit="52.5"/>
                    <measurement group_id="O3" value="6" lower_limit="4.6" upper_limit="24.8"/>
                    <measurement group_id="O4" value="6" lower_limit="4.9" upper_limit="26.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H1N1 (Post-vaccination; N = 46, 47, 49, 46)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="7.7"/>
                    <measurement group_id="O2" value="1" lower_limit="0.1" upper_limit="11.3"/>
                    <measurement group_id="O3" value="0" lower_limit="0" upper_limit="7.3"/>
                    <measurement group_id="O4" value="0" lower_limit="0" upper_limit="7.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2 (pre-vaccination; N = 46, 46, 49, 46)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17" lower_limit="23.2" upper_limit="52.5"/>
                    <measurement group_id="O2" value="19" lower_limit="27.0" upper_limit="56.8"/>
                    <measurement group_id="O3" value="6" lower_limit="4.6" upper_limit="24.8"/>
                    <measurement group_id="O4" value="2" lower_limit="0.5" upper_limit="14.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2 (Post-vaccination; N = 45, 47, 49, 46)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="7.9"/>
                    <measurement group_id="O2" value="1" lower_limit="0.1" upper_limit="11.3"/>
                    <measurement group_id="O3" value="0" lower_limit="0" upper_limit="7.3"/>
                    <measurement group_id="O4" value="0" lower_limit="0" upper_limit="7.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B (Pre-vaccination; N = 46, 46, 49, 46)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12" lower_limit="14.3" upper_limit="41.1"/>
                    <measurement group_id="O2" value="9" lower_limit="9.4" upper_limit="33.9"/>
                    <measurement group_id="O3" value="17" lower_limit="21.7" upper_limit="49.6"/>
                    <measurement group_id="O4" value="13" lower_limit="16.0" upper_limit="43.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B (Post-vaccination; N = 45, 47, 49, 46)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="7.9"/>
                    <measurement group_id="O2" value="1" lower_limit="0.1" upper_limit="11.3"/>
                    <measurement group_id="O3" value="4" lower_limit="2.3" upper_limit="19.6"/>
                    <measurement group_id="O4" value="1" lower_limit="0.1" upper_limit="11.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Fluzone Vaccine (Group 1)</title>
          <description>'Adults 18 to &lt; 65 years of age received one dose of Fluzone vaccine intramuscularly'</description>
        </group>
        <group group_id="E2">
          <title>Fluzone Intradermal Vaccine (Group 2)</title>
          <description>Adults 18 to &lt; 65 years of age received one dose of Fluzone Intradermal vaccine intradermally</description>
        </group>
        <group group_id="E3">
          <title>Fluzone Vaccine (Group 3)</title>
          <description>Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly</description>
        </group>
        <group group_id="E4">
          <title>Fluzone High-Dose Vaccine (Group 4)</title>
          <description>Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 15.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <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"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertensive crisis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5.00</frequency_threshold>
        <default_vocab>MedDRA 15.0</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="12" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="19" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site Pain</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="50"/>
                <counts group_id="E2" events="20" subjects_affected="20" subjects_at_risk="50"/>
                <counts group_id="E3" events="12" subjects_affected="12" subjects_at_risk="51"/>
                <counts group_id="E4" events="19" subjects_affected="19" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Injection site Erythema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" events="16" subjects_affected="16" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Injection site Swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Injection site Induration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="50"/>
                <counts group_id="E2" events="12" subjects_affected="12" subjects_at_risk="50"/>
                <counts group_id="E3" events="11" subjects_affected="11" subjects_at_risk="51"/>
                <counts group_id="E4" events="7" subjects_affected="7" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="50"/>
                <counts group_id="E2" events="11" subjects_affected="11" subjects_at_risk="50"/>
                <counts group_id="E3" events="10" subjects_affected="10" subjects_at_risk="51"/>
                <counts group_id="E4" events="7" subjects_affected="7" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Shivering</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="50"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="50"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="51"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="49"/>
              </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="10" subjects_affected="10" subjects_at_risk="50"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="50"/>
                <counts group_id="E3" events="13" subjects_affected="13" subjects_at_risk="51"/>
                <counts group_id="E4" events="7" subjects_affected="7" subjects_at_risk="49"/>
              </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>Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Director</name_or_title>
      <organization>Sanofi Pasteur Inc.</organization>
      <email>RegistryContactUs@sanofipasteur.com</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/NCT01691339
org study id: GRC50
secondary id: U 1111-1124-8310
nct id: NCT01691339
lead sponsor: 
has dmc: No
The aim of this study is to evaluate the safety and immunogenicity of Fluzone vaccine (18
      years to <65 years of age and ≥ 65 years of age), Fluzone Intradermal vaccine (18 years to
      <65 years of age), and Fluzone High-Dose vaccine (≥ 65 years of age).

      Primary Objective:

        -  To describe the safety of the 2012 - 2013 formulation of Fluzone and Fluzone Intradermal
           vaccines in adults 18 to < 65 years of age and the safety of the 2012 - 2013 formulation
           of Fluzone and Fluzone High-Dose vaccines in adults ≥ 65 years of age.

      Observational Objectives:

        -  To describe the immunogenicity of the 2012 - 2013 formulation of Fluzone and Fluzone
           Intradermal vaccines in adults 18 to < 65 years of age and the immunogenicity of the
           2012 - 2013 formulation of Fluzone and Fluzone High-Dose vaccines in adults ≥ 65 years
           of age.

        -  To evaluate the compliance, in terms of immunogenicity, of each study vaccine (Fluzone,
           Fluzone Intradermal, and Fluzone High-Dose) in the applicable age group with the
           requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance
           (NfG) CPMP/BWP/214/96.

        -  To submit remaining available sera from subjects given Fluzone vaccine to the Center for
           Biologics Evaluation and Research (CBER) for further analysis by the World Health
           Organization (WHO), the Centers for Disease Control and Prevention (CDC), and the Food
           and Drug Administration (FDA) to support selection and recommendation of strains for
           subsequent years' influenza vaccines.
Participants 18 to < 65 years of age will be randomized to receive a dose of either Fluzone
      or Fluzone Intradermal vaccine and participants ≥ 65 years of age will be randomized to
      receive a dose of Fluzone or Fluzone High-Dose vaccine. All participants will be followed up
      for safety and immunogenicity. The duration of participation in the trial will be
      approximately 21 days.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
time frame: Day 0 up to Day 7 post-vaccination
description: Solicited injection site: Pain, Erythema, Swelling, Induration, and Ecchymosis; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering.
Grade 3 injection site: Pain - Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis - >100 mm. Grade 3 systemic reactions: Fever ≥39.0°C; Headache, Malaise, Myalgia, and Shivering - significant, prevents daily activity.
measure: Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
time frame: Day 0 (pre-vaccination) up to Day 21 post-vaccination
description: Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay.
measure: Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
time frame: Day 0 (pre-vaccination) and Day 21 post-vaccination
description: Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay. Seroprotection was defined as a pre-vaccination or a post-vaccination titer ≥ 40 (l/dil).
measure: Number of Adult Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
time frame: Day 0 (pre-vaccination) and Day 21 post-vaccination
description: Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay. Seroconversion was defined as either a pre-vaccination titer < 10 (1/dil) and a post-vaccination titer ≥ 40 (1/dil), or a pre-vaccination titer ≥ 10 (1/dil) and a ≥ 4-fold increase in post-vaccination titer.
measure: Number of Participants With Influenza Antibody Titers of <1:10 Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
time frame: Day 0 (pre-vaccination) and Day 21 post-vaccination
description: Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay to determine pre-vaccination and post-vaccination titers of <1:10.
arm group label: Fluzone vaccine (Group 1)
arm group type: Experimental
description: Adults 18 to < 65 years of age randomized to receive one dose of Fluzone vaccine intramuscularly
arm group label: Fluzone Intradermal vaccine (Group 2)
arm group type: Experimental
description: Adults 18 to < 65 years of age randomized to receive one dose of Fluzone Intradermal vaccine intradermally
arm group label: Fluzone vaccine (Group 3)
arm group type: Experimental
description: Adults ≥ 65 years of age randomized to receive one dose of Fluzone vaccine intramuscularly
arm group label: Fluzone High-Dose Vaccine (Group 4)
arm group type: Active Comparator
description: Adults ≥ 65 years of age randomized to receive one dose of Fluzone High-Dose vaccine intramuscularly
intervention type: Biological
intervention name: Influenza Virus Vaccine: Fluzone® 2012-2013 Formulation
description: 0.5 mL, Intramuscular
arm group label: Fluzone vaccine (Group 1)
other name: Fluzone® (2012-2013 Formulation)
intervention type: Biological
intervention name: Influenza Virus Vaccine: Fluzone® Intradermal 2012-2013 Formulation
description: 0.1 mL, Intradermal
arm group label: Fluzone Intradermal vaccine (Group 2)
other name: Fluzone® Intradermal (2012-2013 Formulation)
intervention type: Biological
intervention name: Influenza Virus Vaccine: Fluzone® 2012-2013 Formulation
description: 0.5 mL, Intramuscular
arm group label: Fluzone vaccine (Group 3)
other name: Fluzone® (2012-2013 Formulation)
intervention type: Biological
intervention name: Influenza Virus Vaccine: Fluzone® High-Dose 2012-2013 Formulation
description: 0.5 mL, Intramuscular
arm group label: Fluzone High-Dose Vaccine (Group 4)
other name: Fluzone® High-Dose (2012-2013 Formulation)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Medical Director
role: Study Director
affiliation: Sanofi Pasteur Inc.
facility: 
facility: 
facility: 
facility: 
country: United States
url: http://www.sanofipasteur.com
description: Related Info
responsible party type: Sponsor
mesh term: Influenza, Human
mesh term: Vaccines
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 