<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/NCT02258334</url>
  </required_header>
  <id_info>
    <org_study_id>GRC55</org_study_id>
    <secondary_id>U1111-1143-8931</secondary_id>
    <nct_id>NCT02258334</nct_id>
  </id_info>
  <brief_title>Study of Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose, Influenza Vaccines in Adults</brief_title>
  <official_title>Safety and Immunogenicity Among Adults of Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose, Influenza Vaccines, 2014-2015 Formulations</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 trial is to evaluate the safety and immunogenicity of the 2014-2015&#xD;
      formulations of Fluzone® Quadrivalent and Fluzone® Intradermal vaccines in adults 18 to &lt; 65&#xD;
      years or age, and of the 2014-2015 formulations of Fluzone® Quadrivalent and Fluzone®&#xD;
      High-Dose vaccines in adults ≥ 65 years of age.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
        -  To describe the safety of the 2014-2015 formulations of Fluzone Quadrivalent and Fluzone&#xD;
           Intradermal vaccines in adults 18 to &lt; 65 years of age and the safety of the 2014-2015&#xD;
           formulations of Fluzone® Quadrivalent and Fluzone® High-Dose vaccines in adults ≥ 65&#xD;
           years of age.&#xD;
&#xD;
      Observational objectives:&#xD;
&#xD;
        -  To describe the immunogenicity of the 2014-2015 formulations of Fluzone® Quadrivalent&#xD;
           and Fluzone® Intradermal vaccines in adults 18 to &lt; 65 years of age and the&#xD;
           immunogenicity of the 2014-2015 formulations of Fluzone® Quadrivalent and Fluzone&#xD;
           ®High-Dose vaccines in adults ≥ 65 years of age.&#xD;
&#xD;
        -  To evaluate the compliance, in terms of immunogenicity, of each study vaccine (Fluzone®&#xD;
           Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose) in the applicable age group&#xD;
           with the historical requirements of the Committee for Human Medicinal Products (CHMP)&#xD;
           Note for Guidance (NfG) CPMP/BWP/214/96.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adults 18 to &lt; 65 years of age will be randomly assigned in a 1:1 ratio to receive either&#xD;
      Fluzone® Quadrivalent or Fluzone® Intradermal vaccine. Adults ≥ 65 years of age will also be&#xD;
      randomly assigned in a 1:1 ratio to receive either Fluzone® Quadrivalent or Fluzone®&#xD;
      High-Dose vaccine.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine</measure>
    <time_frame>Day 0 up to Day 7 post-vaccination</time_frame>
    <description>Injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 Injection-site reactions: Pain, Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, &gt;100 mm. Grade 3 Systemic reactions: Fever, ≥39.0°C or ≥102.1°F; Headache, Malaise, Myalgia, and Shivering, Significant, prevents daily activity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine.</measure>
    <time_frame>Day 0 (pre-vaccination) and Day 21 post-vaccination</time_frame>
    <description>Geometric mean titers of antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine.</measure>
    <time_frame>Day 0 (pre-vaccination) and Day 21 post-vaccination</time_frame>
    <description>Antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay. Seroprotection was defined as a titer ≥40 (l/dilution [dil]) at pre-vaccination and 21 days after vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine</measure>
    <time_frame>Day 21 post-vaccination</time_frame>
    <description>Antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the 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 21 days after vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Titer Ratios (GMTRs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Following Vaccination With the Respective Vaccine</measure>
    <time_frame>Day 21 post-vaccination</time_frame>
    <description>Geometric mean titer ratios of antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">208</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>Fluzone® Quadrivalent vaccine Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adults 18 to &lt; 65 years of age randomly assigned to receive an intramuscular injection of Fluzone® Quadrivalent vaccine</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 randomly assigned to receive an intradermal injection of Fluzone® Intradermal vaccine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fluzone® Quadrivalent vaccine Group 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adults ≥ 65 years of age randomly assigned to receive an intramuscular injection of Fluzone® Quadrivalent vaccine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fluzone® High-Dose vaccine Group 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adults ≥ 65 years of age randomly assigned to receive an intramuscular injection of Fluzone® High-Dose vaccine</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Fluzone® Quadrivalent vaccine, 2014-2015 formulation</intervention_name>
    <description>0.5 mL, Intramuscular</description>
    <arm_group_label>Fluzone® Quadrivalent vaccine Group 1</arm_group_label>
    <other_name>Fluzone® Quadrivalent vaccine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Fluzone I®ntradermal vaccine, 2014-2015 formulation</intervention_name>
    <description>0.1 mL, Intradermal</description>
    <arm_group_label>Fluzone® Intradermal vaccine Group 2</arm_group_label>
    <other_name>Fluzone® Intradermal vaccine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Fluzone® Quadrivalent vaccine, 2014-2015 formulation</intervention_name>
    <description>0.5 mL, Intramuscular</description>
    <arm_group_label>Fluzone® Quadrivalent vaccine Group 3</arm_group_label>
    <other_name>Fluzone® Quadrivalent vaccine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Fluzone High Dose vaccine, 2014-2015 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, vaccine</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 2014-2015 formulation of influenza vaccine.&#xD;
&#xD;
          -  Known systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine&#xD;
             components, or a history of a life-threatening reaction to Fluzone Quadrivalent,&#xD;
             Fluzone Intradermal, or Fluzone High-Dose vaccine or to a vaccine containing any of&#xD;
             the same substances (the complete list of vaccine components is included in the&#xD;
             Prescribing 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, 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 an 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 an 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>Santa Rosa</city>
        <state>California</state>
        <zip>95405</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>
    <facility>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45249</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>September 2015</verification_date>
  <study_first_submitted>October 2, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 7, 2014</study_first_posted>
  <results_first_submitted>September 16, 2015</results_first_submitted>
  <results_first_submitted_qc>September 16, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">October 19, 2015</results_first_posted>
  <last_update_submitted>September 16, 2015</last_update_submitted>
  <last_update_submitted_qc>September 16, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 19, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Influenza</keyword>
  <keyword>Fluzone® Quadrivalent, Influenza Vaccine</keyword>
  <keyword>Fluzone® Intradermal, Influenza Vaccine</keyword>
  <keyword>Fluzone® High-Dose, Influenza Vaccine</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>Study participants were enrolled from 01 October 2014 to 07 November 2014 at 4 clinical sites in the United States.</recruitment_details>
      <pre_assignment_details>A total of 208 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated in this study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Group 1</title>
          <description>Adults 18 to &lt; 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.</description>
        </group>
        <group group_id="P2">
          <title>Group 2</title>
          <description>Adults 18 to &lt; 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.</description>
        </group>
        <group group_id="P3">
          <title>Group 3</title>
          <description>Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.</description>
        </group>
        <group group_id="P4">
          <title>Group 4</title>
          <description>Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High-Dose vaccine.</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="54"/>
                <participants group_id="P3" count="52"/>
                <participants group_id="P4" count="52"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="49"/>
                <participants group_id="P2" count="54"/>
                <participants group_id="P3" count="52"/>
                <participants group_id="P4" count="52"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Group 1</title>
          <description>Adults 18 to &lt; 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.</description>
        </group>
        <group group_id="B2">
          <title>Group 2</title>
          <description>Adults 18 to &lt; 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.</description>
        </group>
        <group group_id="B3">
          <title>Group 3</title>
          <description>Adults ≥ 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.</description>
        </group>
        <group group_id="B4">
          <title>Group 4</title>
          <description>Adults ≥ 65 years of age randomly assigned to receive an intramuscular dose of Fluzone High-Dose vaccine.</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="54"/>
            <count group_id="B3" value="52"/>
            <count group_id="B4" value="52"/>
            <count group_id="B5" value="208"/>
          </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="54"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="104"/>
                  </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="52"/>
                    <measurement group_id="B4" value="52"/>
                    <measurement group_id="B5" value="104"/>
                  </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>
              <title>Age Continuous</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44.8" spread="14.9"/>
                    <measurement group_id="B2" value="48.0" spread="12.1"/>
                    <measurement group_id="B3" value="73.9" spread="5.0"/>
                    <measurement group_id="B4" value="72.2" spread="5.4"/>
                    <measurement group_id="B5" value="59.8" spread="16.8"/>
                  </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="33"/>
                    <measurement group_id="B3" value="32"/>
                    <measurement group_id="B4" value="31"/>
                    <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="20"/>
                    <measurement group_id="B4" value="21"/>
                    <measurement group_id="B5" value="81"/>
                  </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="54"/>
                    <measurement group_id="B3" value="52"/>
                    <measurement group_id="B4" value="52"/>
                    <measurement group_id="B5" value="208"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine</title>
        <description>Injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 Injection-site reactions: Pain, Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, &gt;100 mm. Grade 3 Systemic reactions: Fever, ≥39.0°C or ≥102.1°F; 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 and systemic reactions were assessed in the Safety Analysis Set.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1</title>
            <description>Adults 18 to &lt; 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.</description>
          </group>
          <group group_id="O2">
            <title>Group 2</title>
            <description>Adults 18 to &lt; 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.</description>
          </group>
          <group group_id="O3">
            <title>Group 3</title>
            <description>Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.</description>
          </group>
          <group group_id="O4">
            <title>Group 4</title>
            <description>Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High-Dose vaccine.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine</title>
          <description>Injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 Injection-site reactions: Pain, Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, &gt;100 mm. Grade 3 Systemic reactions: Fever, ≥39.0°C or ≥102.1°F; Headache, Malaise, Myalgia, and Shivering, Significant, prevents daily activity.</description>
          <population>Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="54"/>
                <count group_id="O3" value="52"/>
                <count group_id="O4" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Injection-site Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.1"/>
                    <measurement group_id="O2" value="51.9"/>
                    <measurement group_id="O3" value="36.5"/>
                    <measurement group_id="O4" value="40.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Injection-site Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="1.9"/>
                    <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="6.1"/>
                    <measurement group_id="O2" value="35.2"/>
                    <measurement group_id="O3" value="3.8"/>
                    <measurement group_id="O4" value="7.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Injection site Erythema</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <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="4.1"/>
                    <measurement group_id="O2" value="22.2"/>
                    <measurement group_id="O3" value="5.8"/>
                    <measurement group_id="O4" value="5.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Injection-site Swelling</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <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="6.1"/>
                    <measurement group_id="O2" value="18.5"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Injection-site Induration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <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="2.0"/>
                    <measurement group_id="O2" value="5.6"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Injection-site Ecchymosis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <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="0.0"/>
                    <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>Grade 3 Fever</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <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="28.6"/>
                    <measurement group_id="O2" value="18.5"/>
                    <measurement group_id="O3" value="17.3"/>
                    <measurement group_id="O4" value="25.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Headache</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Malaise</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.3"/>
                    <measurement group_id="O2" value="27.8"/>
                    <measurement group_id="O3" value="9.6"/>
                    <measurement group_id="O4" value="15.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Malaise</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="1.9"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.5"/>
                    <measurement group_id="O2" value="25.9"/>
                    <measurement group_id="O3" value="23.1"/>
                    <measurement group_id="O4" value="28.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Myalgia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="1.9"/>
                    <measurement group_id="O3" value="1.9"/>
                    <measurement group_id="O4" value="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Shivering</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1"/>
                    <measurement group_id="O2" value="9.3"/>
                    <measurement group_id="O3" value="1.9"/>
                    <measurement group_id="O4" value="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Shivering</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <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>Secondary</type>
        <title>Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine.</title>
        <description>Geometric mean titers of antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay.</description>
        <time_frame>Day 0 (pre-vaccination) and Day 21 post-vaccination</time_frame>
        <population>Geometric mean titers were assessed in the Per-Protocol Analysis Set.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1</title>
            <description>Adults 18 to &lt; 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.</description>
          </group>
          <group group_id="O2">
            <title>Group 2</title>
            <description>Adults 18 to &lt; 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.</description>
          </group>
          <group group_id="O3">
            <title>Group 3</title>
            <description>Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.</description>
          </group>
          <group group_id="O4">
            <title>Group 4</title>
            <description>Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High-Dose vaccine.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine.</title>
          <description>Geometric mean titers of antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay.</description>
          <population>Geometric mean titers were assessed in the Per-Protocol Analysis Set.</population>
          <units>Titers (1/dilution)</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="49"/>
                <count group_id="O2" value="53"/>
                <count group_id="O3" value="52"/>
                <count group_id="O4" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A/H1N1; Pre-vaccination (N=49,52,52,52)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="153" lower_limit="90.6" upper_limit="260"/>
                    <measurement group_id="O2" value="148" lower_limit="94.3" upper_limit="231"/>
                    <measurement group_id="O3" value="148" lower_limit="96.7" upper_limit="226"/>
                    <measurement group_id="O4" value="171" lower_limit="124" upper_limit="237"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H1N1; Post-vaccination (N=49,53,52,52)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="707" lower_limit="490" upper_limit="1020"/>
                    <measurement group_id="O2" value="632" lower_limit="459" upper_limit="870"/>
                    <measurement group_id="O3" value="288" lower_limit="200" upper_limit="414"/>
                    <measurement group_id="O4" value="386" lower_limit="294" upper_limit="506"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2; Pre-vaccination (N=49,53,52,52)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="139" lower_limit="90.9" upper_limit="212"/>
                    <measurement group_id="O2" value="147" lower_limit="97.6" upper_limit="221"/>
                    <measurement group_id="O3" value="168" lower_limit="119" upper_limit="237"/>
                    <measurement group_id="O4" value="275" lower_limit="193" upper_limit="390"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2; Post-vaccination (N=49,53,52,52)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="613" lower_limit="439" upper_limit="857"/>
                    <measurement group_id="O2" value="648" lower_limit="470" upper_limit="894"/>
                    <measurement group_id="O3" value="349" lower_limit="244" upper_limit="499"/>
                    <measurement group_id="O4" value="680" lower_limit="490" upper_limit="942"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B (Yamagata); Pre-vaccination (N=49,53,52,52)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="596" lower_limit="400" upper_limit="888"/>
                    <measurement group_id="O2" value="471" lower_limit="324" upper_limit="684"/>
                    <measurement group_id="O3" value="471" lower_limit="342" upper_limit="649"/>
                    <measurement group_id="O4" value="465" lower_limit="340" upper_limit="635"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B (Yamagata); Post-vaccination (N=49,53,52,52)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1836" lower_limit="1376" upper_limit="2449"/>
                    <measurement group_id="O2" value="1272" lower_limit="906" upper_limit="1785"/>
                    <measurement group_id="O3" value="864" lower_limit="651" upper_limit="1146"/>
                    <measurement group_id="O4" value="994" lower_limit="777" upper_limit="1270"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B (Victoria); Pre-vaccination (N=49,0,52,0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="252" lower_limit="164" upper_limit="385"/>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">B (Victoria) antigen was not in the administered vaccine</measurement>
                    <measurement group_id="O3" value="273" lower_limit="195" upper_limit="382"/>
                    <measurement group_id="O4" value="NA" lower_limit="NA" upper_limit="NA">B (Victoria) antigen was not in the administered vaccine</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B (Victoria); Post-vaccination (N=49,0,52,0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1119" lower_limit="838" upper_limit="1495"/>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">B (Victoria) antigen was not in the administered vaccine</measurement>
                    <measurement group_id="O3" value="568" lower_limit="430" upper_limit="750"/>
                    <measurement group_id="O4" value="NA" lower_limit="NA" upper_limit="NA">B (Victoria) antigen was not in the administered vaccine</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine.</title>
        <description>Antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay. Seroprotection was defined as a titer ≥40 (l/dilution [dil]) at pre-vaccination and 21 days after vaccination.</description>
        <time_frame>Day 0 (pre-vaccination) and Day 21 post-vaccination</time_frame>
        <population>Seroprotection was assessed in the Per-Protocol Analysis Set.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1</title>
            <description>Adults 18 to &lt; 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.</description>
          </group>
          <group group_id="O2">
            <title>Group 2</title>
            <description>Adults 18 to &lt; 65 years of age randomly assigned to receive an intradermal of Fluzone Intradermal vaccine.</description>
          </group>
          <group group_id="O3">
            <title>Group 3</title>
            <description>Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.</description>
          </group>
          <group group_id="O4">
            <title>Group 4</title>
            <description>Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High-Dose vaccine.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine.</title>
          <description>Antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay. Seroprotection was defined as a titer ≥40 (l/dilution [dil]) at pre-vaccination and 21 days after vaccination.</description>
          <population>Seroprotection was assessed in the Per-Protocol Analysis Set.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="53"/>
                <count group_id="O3" value="52"/>
                <count group_id="O4" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A/H1N1; Pre-vaccination (N=49,52,52,52)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.6"/>
                    <measurement group_id="O2" value="84.6"/>
                    <measurement group_id="O3" value="82.7"/>
                    <measurement group_id="O4" value="90.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H1N1; Post-vaccination (N=49,53,52,52)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.0"/>
                    <measurement group_id="O2" value="100.0"/>
                    <measurement group_id="O3" value="92.3"/>
                    <measurement group_id="O4" value="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2; Pre-vaccination (N=49,53,52,52)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.6"/>
                    <measurement group_id="O2" value="83.0"/>
                    <measurement group_id="O3" value="90.4"/>
                    <measurement group_id="O4" value="96.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2; Post-vaccination (N=49,53,52,52)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.0"/>
                    <measurement group_id="O2" value="100.0"/>
                    <measurement group_id="O3" value="94.2"/>
                    <measurement group_id="O4" value="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B (Yamagata); Pre-vaccination (N=49,53,52,52)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.0"/>
                    <measurement group_id="O2" value="98.1"/>
                    <measurement group_id="O3" value="96.2"/>
                    <measurement group_id="O4" value="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B (Yamagata); Post-vaccination (N=49,53,52,52)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0"/>
                    <measurement group_id="O2" value="100.0"/>
                    <measurement group_id="O3" value="100.0"/>
                    <measurement group_id="O4" value="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B (Victoria); Pre-vaccination (n=49,0,52,0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.8"/>
                    <measurement group_id="O2" value="NA">B (Victoria) antigen was not in the administered vaccine</measurement>
                    <measurement group_id="O3" value="94.2"/>
                    <measurement group_id="O4" value="NA">B (Victoria) antigen was not in the administered vaccine</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B (Victoria); Post-vaccination (N=49,0,52,0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0"/>
                    <measurement group_id="O2" value="NA">B (Victoria) antigen was not in the administered vaccine</measurement>
                    <measurement group_id="O3" value="100.0"/>
                    <measurement group_id="O4" value="NA">B (Victoria) antigen was not in the administered vaccine</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine</title>
        <description>Antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the 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 21 days after vaccination.</description>
        <time_frame>Day 21 post-vaccination</time_frame>
        <population>Seroconversion was assessed in the Per-Protocol Analysis Set.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1</title>
            <description>Adults 18 to &lt; 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.</description>
          </group>
          <group group_id="O2">
            <title>Group 2</title>
            <description>Adults 18 to &lt; 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.</description>
          </group>
          <group group_id="O3">
            <title>Group 3</title>
            <description>Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.</description>
          </group>
          <group group_id="O4">
            <title>Group 4</title>
            <description>Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High Dose vaccine.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine</title>
          <description>Antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the 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 21 days after vaccination.</description>
          <population>Seroconversion was assessed in the Per-Protocol Analysis Set.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="53"/>
                <count group_id="O3" value="52"/>
                <count group_id="O4" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A/H1N1 (N=49,52,52,52)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.7"/>
                    <measurement group_id="O2" value="42.3"/>
                    <measurement group_id="O3" value="15.4"/>
                    <measurement group_id="O4" value="28.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2 (N=49,53,52,52)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.8"/>
                    <measurement group_id="O2" value="39.6"/>
                    <measurement group_id="O3" value="23.1"/>
                    <measurement group_id="O4" value="26.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B (Yamagata) (N=49,53,52,52)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.6"/>
                    <measurement group_id="O2" value="28.3"/>
                    <measurement group_id="O3" value="15.4"/>
                    <measurement group_id="O4" value="21.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B (Victoria) (N=49,0,52,0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.0"/>
                    <measurement group_id="O2" value="NA">B (Victoria) antigen was not in the administered vaccine</measurement>
                    <measurement group_id="O3" value="23.1"/>
                    <measurement group_id="O4" value="NA">B (Victoria) antigen was not in the administered vaccine</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Titer Ratios (GMTRs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Following Vaccination With the Respective Vaccine</title>
        <description>Geometric mean titer ratios of antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay.</description>
        <time_frame>Day 21 post-vaccination</time_frame>
        <population>Geometric mean titer ratios were assessed in the Per-Protocol Analysis Set.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1</title>
            <description>Adults 18 to &lt; 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.</description>
          </group>
          <group group_id="O2">
            <title>Group 2</title>
            <description>Adults 18 to &lt; 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.</description>
          </group>
          <group group_id="O3">
            <title>Group 3</title>
            <description>Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.</description>
          </group>
          <group group_id="O4">
            <title>Group 4</title>
            <description>Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High Dose vaccine.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titer Ratios (GMTRs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Following Vaccination With the Respective Vaccine</title>
          <description>Geometric mean titer ratios of antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay.</description>
          <population>Geometric mean titer ratios were assessed in the Per-Protocol Analysis Set.</population>
          <units>Titer ratios</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="49"/>
                <count group_id="O2" value="53"/>
                <count group_id="O3" value="52"/>
                <count group_id="O4" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A/H1N1 (N=49,52,52,52)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.32" lower_limit="2.66" upper_limit="7.04"/>
                    <measurement group_id="O2" value="3.92" lower_limit="2.54" upper_limit="6.06"/>
                    <measurement group_id="O3" value="1.91" lower_limit="1.53" upper_limit="2.38"/>
                    <measurement group_id="O4" value="2.25" lower_limit="1.79" upper_limit="2.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2 (N=49,53,52,52)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.26" lower_limit="2.83" upper_limit="6.42"/>
                    <measurement group_id="O2" value="4.24" lower_limit="2.93" upper_limit="6.14"/>
                    <measurement group_id="O3" value="2.08" lower_limit="1.65" upper_limit="2.62"/>
                    <measurement group_id="O4" value="2.48" lower_limit="1.97" upper_limit="3.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B (Yamagata) (N=49,53,52,52)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.08" lower_limit="2.21" upper_limit="4.29"/>
                    <measurement group_id="O2" value="2.70" lower_limit="1.95" upper_limit="3.74"/>
                    <measurement group_id="O3" value="1.83" lower_limit="1.48" upper_limit="2.28"/>
                    <measurement group_id="O4" value="2.14" lower_limit="1.72" upper_limit="2.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B (Victoria) (N=49,0,52,0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.39" lower_limit="3.05" upper_limit="6.30"/>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">B (Victoria) antigen was not in the administered vaccine</measurement>
                    <measurement group_id="O3" value="2.08" lower_limit="1.62" upper_limit="2.68"/>
                    <measurement group_id="O4" value="NA" lower_limit="NA" upper_limit="NA">B (Victoria) antigen was not in the administered vaccine</measurement>
                  </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 21 post-vaccination.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Group 1</title>
          <description>Adults 18 to &lt; 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.</description>
        </group>
        <group group_id="E2">
          <title>Group 2</title>
          <description>Adults 18 to &lt; 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.</description>
        </group>
        <group group_id="E3">
          <title>Group 3</title>
          <description>Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.</description>
        </group>
        <group group_id="E4">
          <title>Group 4</title>
          <description>Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High Dose vaccine.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 16.0</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="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5.00</frequency_threshold>
        <default_vocab>MedDRA 16.0</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="49"/>
                <counts group_id="E2" subjects_affected="28" subjects_at_risk="54"/>
                <counts group_id="E3" subjects_affected="19" subjects_at_risk="52"/>
                <counts group_id="E4" subjects_affected="21" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site Pain</sub_title>
                <counts group_id="E1" events="26" subjects_affected="26" subjects_at_risk="49"/>
                <counts group_id="E2" events="28" subjects_affected="28" subjects_at_risk="54"/>
                <counts group_id="E3" events="19" subjects_affected="19" subjects_at_risk="52"/>
                <counts group_id="E4" events="21" subjects_affected="21" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Injection site Erythema</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E2" events="19" subjects_affected="19" subjects_at_risk="54"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="52"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Injection site Swelling</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E2" events="12" subjects_affected="12" subjects_at_risk="54"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="52"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Injection site Induration</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="54"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Injection site Ecchymosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="54"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="52"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="49"/>
                <counts group_id="E2" events="15" subjects_affected="15" subjects_at_risk="54"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="52"/>
                <counts group_id="E4" events="8" subjects_affected="8" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Shivering</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="54"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="52"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="52"/>
              </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="13" subjects_affected="13" subjects_at_risk="49"/>
                <counts group_id="E2" events="14" subjects_affected="14" subjects_at_risk="54"/>
                <counts group_id="E3" events="12" subjects_affected="12" subjects_at_risk="52"/>
                <counts group_id="E4" events="15" subjects_affected="15" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="14" subjects_affected="14" subjects_at_risk="49"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="54"/>
                <counts group_id="E3" events="9" subjects_affected="9" subjects_at_risk="52"/>
                <counts group_id="E4" events="13" subjects_affected="13" subjects_at_risk="52"/>
              </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/NCT02258334
org study id: GRC55
secondary id: U1111-1143-8931
nct id: NCT02258334
lead sponsor: 
has dmc: No
The aim of this trial is to evaluate the safety and immunogenicity of the 2014-2015
      formulations of Fluzone® Quadrivalent and Fluzone® Intradermal vaccines in adults 18 to < 65
      years or age, and of the 2014-2015 formulations of Fluzone® Quadrivalent and Fluzone®
      High-Dose vaccines in adults ≥ 65 years of age.

      Objectives:

        -  To describe the safety of the 2014-2015 formulations of Fluzone Quadrivalent and Fluzone
           Intradermal vaccines in adults 18 to < 65 years of age and the safety of the 2014-2015
           formulations of Fluzone® Quadrivalent and Fluzone® High-Dose vaccines in adults ≥ 65
           years of age.

      Observational objectives:

        -  To describe the immunogenicity of the 2014-2015 formulations of Fluzone® Quadrivalent
           and Fluzone® Intradermal vaccines in adults 18 to < 65 years of age and the
           immunogenicity of the 2014-2015 formulations of Fluzone® Quadrivalent and Fluzone
           ®High-Dose vaccines in adults ≥ 65 years of age.

        -  To evaluate the compliance, in terms of immunogenicity, of each study vaccine (Fluzone®
           Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose) in the applicable age group
           with the historical requirements of the Committee for Human Medicinal Products (CHMP)
           Note for Guidance (NfG) CPMP/BWP/214/96.
Adults 18 to < 65 years of age will be randomly assigned in a 1:1 ratio to receive either
      Fluzone® Quadrivalent or Fluzone® Intradermal vaccine. Adults ≥ 65 years of age will also be
      randomly assigned in a 1:1 ratio to receive either Fluzone® Quadrivalent or Fluzone®
      High-Dose vaccine.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
time frame: Day 0 up to Day 7 post-vaccination
description: Injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 Injection-site reactions: Pain, Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, >100 mm. Grade 3 Systemic reactions: Fever, ≥39.0°C or ≥102.1°F; Headache, Malaise, Myalgia, and Shivering, Significant, prevents daily activity.
measure: Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine.
time frame: Day 0 (pre-vaccination) and Day 21 post-vaccination
description: Geometric mean titers of antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay.
measure: Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine.
time frame: Day 0 (pre-vaccination) and Day 21 post-vaccination
description: Antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay. Seroprotection was defined as a titer ≥40 (l/dilution [dil]) at pre-vaccination and 21 days after vaccination.
measure: Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine
time frame: Day 21 post-vaccination
description: Antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the 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 21 days after vaccination.
measure: Geometric Mean Titer Ratios (GMTRs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Following Vaccination With the Respective Vaccine
time frame: Day 21 post-vaccination
description: Geometric mean titer ratios of antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay.
arm group label: Fluzone® Quadrivalent vaccine Group 1
arm group type: Experimental
description: Adults 18 to < 65 years of age randomly assigned to receive an intramuscular injection of Fluzone® Quadrivalent vaccine
arm group label: Fluzone® Intradermal vaccine Group 2
arm group type: Experimental
description: Adults 18 to < 65 years of age randomly assigned to receive an intradermal injection of Fluzone® Intradermal vaccine
arm group label: Fluzone® Quadrivalent vaccine Group 3
arm group type: Experimental
description: Adults ≥ 65 years of age randomly assigned to receive an intramuscular injection of Fluzone® Quadrivalent vaccine
arm group label: Fluzone® High-Dose vaccine Group 4
arm group type: Experimental
description: Adults ≥ 65 years of age randomly assigned to receive an intramuscular injection of Fluzone® High-Dose vaccine
intervention type: Biological
intervention name: Fluzone® Quadrivalent vaccine, 2014-2015 formulation
description: 0.5 mL, Intramuscular
arm group label: Fluzone® Quadrivalent vaccine Group 1
other name: Fluzone® Quadrivalent vaccine
intervention type: Biological
intervention name: Fluzone I®ntradermal vaccine, 2014-2015 formulation
description: 0.1 mL, Intradermal
arm group label: Fluzone® Intradermal vaccine Group 2
other name: Fluzone® Intradermal vaccine
intervention type: Biological
intervention name: Fluzone® Quadrivalent vaccine, 2014-2015 formulation
description: 0.5 mL, Intramuscular
arm group label: Fluzone® Quadrivalent vaccine Group 3
other name: Fluzone® Quadrivalent vaccine
intervention type: Biological
intervention name: Fluzone High Dose vaccine, 2014-2015 formulation
description: 0.5 mL, Intramuscular
arm group label: Fluzone® High-Dose vaccine Group 4
other name: Fluzone® High Dose, vaccine
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: 