<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/NCT01688921</url>
  </required_header>
  <id_info>
    <org_study_id>PJ-501-12-2</org_study_id>
    <nct_id>NCT01688921</nct_id>
  </id_info>
  <brief_title>Jet Injection for Influenza</brief_title>
  <acronym>JIFI</acronym>
  <official_title>Jet Injection for Influenza: A Randomized Controlled Clinical Trial to Demonstrate Non Inferiority of Jet Injection vs. Needle and Syringe for Administration of Trivalent Inactivated Influenza Vaccine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>PharmaJet, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>PharmaJet, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if the administration of a seasonal flu vaccine&#xD;
      using a PharmaJet's needle-free injection device (STRATIS) is equivalent to needle and&#xD;
      syringe administration, as measured by laboratory tests of immune response.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</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>Anti Influenza Type A/H1N1 Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT)</measure>
    <time_frame>28 days</time_frame>
    <description>The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio(GMT with NS / GMT with PJ Stratis) for A/H1N1 antigen will not exceed 1.5 fold.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anti Influenza Type A/H2N3 Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT)</measure>
    <time_frame>28 days</time_frame>
    <description>The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio(GMT with NS / GMT with PJ Stratis) for each antigen to not exceed 1.5 fold.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anti Influenza Type B Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT)</measure>
    <time_frame>28 days</time_frame>
    <description>The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio(GMT with NS / GMT with PJ Stratis) for each antigen to not exceed 1.5 fold.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anti Influenza Type A/H1N1 Seroconversion</measure>
    <time_frame>28 days</time_frame>
    <description>Seroconversion is defined as a 4-fold rise in HAI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (&lt;1:10), attainment of a post-immunization titer of ≥1:40.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anti Influenza Type A/H3N2 Seroconversion</measure>
    <time_frame>28 days</time_frame>
    <description>Seroconversion is defined as a 4-fold rise in HAI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (&lt;1:10), attainment of a post-immunization titer of ≥1:40.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anti Influenza Type B Seroconversion</measure>
    <time_frame>28 days</time_frame>
    <description>Seroconversion is defined as a 4-fold rise in HAI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (&lt;1:10), attainment of a post-immunization titer of ≥1:40.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Complaints Within 30 Minutes Following Vaccination</measure>
    <time_frame>Within 30 minutes post-vaccination</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Vaccine Reactogenicity Events</measure>
    <time_frame>Day 0, 1, 2, 3, 4, 5, and 6</time_frame>
    <description>Vaccine reactogenicity will be collected on a patient-completed diary card during checkout from Day 0 and on the next six evenings post-vaccination. The following adverse events will be solicited on the diary card: pain at injection site, tenderness at injection site, redness where the injection is given; induration/swelling (lump) where the injection is given; bruising where the injection is given; itching where the injection is given; headache; tiredness/fatigue (asthenia, lethargy, malaise); general muscle ache (myalgia); chills; nausea; vomiting. Subjects will also record their oral temperature on the diary card each evening.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Spontaneously Reported Adverse Events</measure>
    <time_frame>28 days</time_frame>
    <description>Subjects will be asked to report any other symptoms experienced in addition to the solicited &quot;immediate&quot; and &quot;vaccine reactogenicity&quot; events. Any other events reported will be tabulated as spontaneously reported adverse events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects Who Received a PJ Stratis Injection Would Choose to Receive This Type of Injection Again</measure>
    <time_frame>28 Days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1250</enrollment>
  <condition>Influenza, Human</condition>
  <arm_group>
    <arm_group_label>STRATIS Needle-Free</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients assigned to this arm will receive AFLURIA vaccine administered using the Stratis needle-free injection device.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Needle-Syringe</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>AFLURIA vaccine (2012-2013 formulation)</intervention_name>
    <description>Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.</description>
    <arm_group_label>Needle-Syringe</arm_group_label>
    <arm_group_label>STRATIS Needle-Free</arm_group_label>
    <other_name>trivalent inactivated influenza vaccine (TIV)</other_name>
    <other_name>influenza virus vaccine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Needle-Syringe</intervention_name>
    <arm_group_label>Needle-Syringe</arm_group_label>
    <arm_group_label>STRATIS Needle-Free</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Stratis needle-free injection device</intervention_name>
    <arm_group_label>Needle-Syringe</arm_group_label>
    <arm_group_label>STRATIS Needle-Free</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults aged ≥18 and ≤64 years of age at the time of enrollment&#xD;
&#xD;
          -  Willing and able to give informed consent after reading the consent form and adequate&#xD;
             opportunity to discuss the study with the investigator or qualified designee&#xD;
&#xD;
          -  Willing and able to adhere to all protocol required study procedures and to attend&#xD;
             scheduled visits.&#xD;
&#xD;
          -  Able to receive the TIV influenza vaccine, based on University of Colorado Health&#xD;
             (UCH) employee health flu screening guidelines.&#xD;
&#xD;
          -  Stable health status with no exclusionary medical or neuropsychiatric conditions as&#xD;
             determined during the screening evaluation and based on the clinical judgment of the&#xD;
             investigator or qualified designee.&#xD;
&#xD;
          -  Access to a consistent means of telephone contact&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of any febrile illness (oral temperature &gt;38°C) on the day of immunization.&#xD;
             Such subjects will be reevaluated for enrollment after resolution of illness.&#xD;
&#xD;
          -  Presence of significant acute or chronic uncontrolled medical or neuropsychiatric&#xD;
             illness and /or presence of any significant condition that may prohibit inclusion as&#xD;
             determined by the investigator or his qualified designee. Uncontrolled is defined as:&#xD;
             requiring institution of a new treatment within 1 month prior to study enrollment or&#xD;
             change in medication dosage in the month prior to study enrollment.&#xD;
&#xD;
          -  Any immunosuppressive condition including: history of HIV infection, cancer or cancer&#xD;
             treatment within 3 years of study enrollment, systemic glucocorticoids (in a dose ≥10&#xD;
             mg prednisone daily or equivalent for more than 7 consecutive days or for 10 or more&#xD;
             days in total) within 1 month of study enrollment, or any other cytotoxic or&#xD;
             immunosuppressive drug within 3 months of study enrollment. Any significant disorder&#xD;
             of coagulation that would increase the risk of intramuscular injections or treatment&#xD;
             with Coumadin derivatives or heparin.&#xD;
&#xD;
          -  Known or suspected to be allergic to eggs, chicken protein, gentamicin or influenza&#xD;
             vaccine.&#xD;
&#xD;
          -  History of severe or previous serious adverse reaction after an influenza vaccination.&#xD;
&#xD;
          -  Receipt of any immunoglobulin and/or blood products within 3 months of immunization or&#xD;
             planned administration of any of these products during the study period.&#xD;
&#xD;
          -  Prior history of any demyelinating disease including Guillain-Barre syndrome.&#xD;
&#xD;
          -  Presence of an active neurological disorder.&#xD;
&#xD;
          -  History of significant alcohol or drug abuse within one year prior to study&#xD;
             enrollment.&#xD;
&#xD;
          -  Influenza vaccination or laboratory confirmed influenza infection within the previous&#xD;
             six months before study vaccination or planned influenza vaccination during the study&#xD;
             period.&#xD;
&#xD;
          -  Planned administration of any non-influenza vaccines 30 days prior to the study or&#xD;
             during the study period.&#xD;
&#xD;
          -  Pregnant or plans to become pregnant during the study period.&#xD;
&#xD;
          -  Currently enrolled in another vaccine or drug study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David K Cobb, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rocky Mountain Infectious Disease Consultants</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Linda McAllister, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>PharmaJet, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Poudre Valley Hospital</name>
      <address>
        <city>Fort Collins</city>
        <state>Colorado</state>
        <zip>80524</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado Health Harmony Campus</name>
      <address>
        <city>Fort Collins</city>
        <state>Colorado</state>
        <zip>80528</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center of the Rockies</name>
      <address>
        <city>Loveland</city>
        <state>Colorado</state>
        <zip>80538</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 17, 2012</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 20, 2012</study_first_posted>
  <results_first_submitted>September 15, 2014</results_first_submitted>
  <results_first_submitted_qc>October 16, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">October 22, 2014</results_first_posted>
  <disposition_first_submitted>March 5, 2013</disposition_first_submitted>
  <disposition_first_submitted_qc>March 5, 2013</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">March 14, 2013</disposition_first_posted>
  <last_update_submitted>September 29, 2017</last_update_submitted>
  <last_update_submitted_qc>September 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Injections, Jet</keyword>
  <keyword>Influenza Vaccines</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>
      <group_list>
        <group group_id="P1">
          <title>STRATIS</title>
          <description>Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.&#xD;
AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.&#xD;
STRATIS needle-free injection device</description>
        </group>
        <group group_id="P2">
          <title>Needle-Syringe</title>
          <description>Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.&#xD;
AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.&#xD;
Needle-Syringe</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="627"/>
                <participants group_id="P2" count="623"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="611"/>
                <participants group_id="P2" count="608"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>informed consent</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Three subjects randomized to the PJ Stratis arm did not have properly documented informed consent and were excluded from the Full Analysis Set (FAS).</population>
      <group_list>
        <group group_id="B1">
          <title>STRATIS</title>
          <description>Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.&#xD;
AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.&#xD;
STRATIS needle-free injection device</description>
        </group>
        <group group_id="B2">
          <title>Needle-Syringe</title>
          <description>Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.&#xD;
AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.&#xD;
Needle-Syringe</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="624"/>
            <count group_id="B2" value="623"/>
            <count group_id="B3" value="1247"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41.3" spread="12.92"/>
                    <measurement group_id="B2" value="41.5" spread="12.49"/>
                    <measurement group_id="B3" value="41.4" spread="12.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="624"/>
                    <measurement group_id="B2" value="623"/>
                    <measurement group_id="B3" value="1247"/>
                  </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="0"/>
                  </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="449"/>
                    <measurement group_id="B2" value="432"/>
                    <measurement group_id="B3" value="881"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="175"/>
                    <measurement group_id="B2" value="191"/>
                    <measurement group_id="B3" value="366"/>
                  </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="624"/>
                    <measurement group_id="B2" value="623"/>
                    <measurement group_id="B3" value="1247"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Anti Influenza Type A/H1N1 Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT)</title>
        <description>The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio(GMT with NS / GMT with PJ Stratis) for A/H1N1 antigen will not exceed 1.5 fold.</description>
        <time_frame>28 days</time_frame>
        <population>The immunogenicity analyses were conducted using data from subjects in the Immunogenicity Population.</population>
        <group_list>
          <group group_id="O1">
            <title>PJ STRATIS</title>
            <description>Patients assigned to this arm will receive AFLURIA vaccine administered using the PJ STRATIS needle-free injection device.&#xD;
AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.&#xD;
PJ STRATIS needle-free injection device</description>
          </group>
          <group group_id="O2">
            <title>Needle-Syringe</title>
            <description>Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.&#xD;
AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.&#xD;
Needle-Syringe</description>
          </group>
        </group_list>
        <measure>
          <title>Anti Influenza Type A/H1N1 Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT)</title>
          <description>The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio(GMT with NS / GMT with PJ Stratis) for A/H1N1 antigen will not exceed 1.5 fold.</description>
          <population>The immunogenicity analyses were conducted using data from subjects in the Immunogenicity Population.</population>
          <units>Titers</units>
          <param>Geometric Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="562"/>
                <count group_id="O2" value="568"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.43" spread="1.348"/>
                    <measurement group_id="O2" value="4.38" spread="1.352"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.64" spread="1.006"/>
                    <measurement group_id="O2" value="5.64" spread="0.997"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>For a sample size of 550 per group each test has an individual power of &gt; 99% to rule out the 1.5-fold difference using a two-sided α = 0.05, assuming equal GMTs between the two treatment groups. The overall power for the study to demonstrate the non-inferiority for the 6 co-primary endpoints is &gt; 80%, computed as product of 6 individual powers.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>The non-inferiority margin was defined as the upper bound of the two-sided 95% CI of the GMT ratio (GMT with NS / GMT with PJ Stratis) for each antigen did not exceed 1.5 fold.</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>0.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.88</ci_lower_limit>
            <ci_upper_limit>1.12</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Anti Influenza Type A/H2N3 Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT)</title>
        <description>The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio(GMT with NS / GMT with PJ Stratis) for each antigen to not exceed 1.5 fold.</description>
        <time_frame>28 days</time_frame>
        <population>The immunogenicity analyses were conducted using data from subjects in the Immunogenicity Population.</population>
        <group_list>
          <group group_id="O1">
            <title>PJ STRATIS</title>
            <description>Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.&#xD;
AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.&#xD;
PJ STRATIS needle-free injection device</description>
          </group>
          <group group_id="O2">
            <title>Needle-Syringe</title>
            <description>Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.&#xD;
AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.&#xD;
Needle-Syringe</description>
          </group>
        </group_list>
        <measure>
          <title>Anti Influenza Type A/H2N3 Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT)</title>
          <description>The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio(GMT with NS / GMT with PJ Stratis) for each antigen to not exceed 1.5 fold.</description>
          <population>The immunogenicity analyses were conducted using data from subjects in the Immunogenicity Population.</population>
          <units>Titers</units>
          <param>Geometric Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="562"/>
                <count group_id="O2" value="568"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.22" spread="1.283"/>
                    <measurement group_id="O2" value="4.32" spread="1.290"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.51" spread="1.022"/>
                    <measurement group_id="O2" value="5.58" spread="0.987"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>For a sample size of 550 per group each test has an individual power of &gt; 99% to rule out the 1.5-fold difference using a two-sided α = 0.05, assuming equal GMTs between the two treatment groups. The overall power for the study to demonstrate the non-inferiority for the 6 co-primary endpoints is &gt; 80%, computed as product of 6 individual powers.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>The non-inferiority margin was defined as the upper bound of the two-sided 95% CI of the GMT ratio (GMT with NS / GMT with PJ Stratis) for each antigen did not exceed 1.5 fold.</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>1.08</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.96</ci_lower_limit>
            <ci_upper_limit>1.21</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Anti Influenza Type B Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT)</title>
        <description>The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio(GMT with NS / GMT with PJ Stratis) for each antigen to not exceed 1.5 fold.</description>
        <time_frame>28 days</time_frame>
        <population>The immunogenicity analyses were conducted using data from subjects in the Immunogenicity Population.</population>
        <group_list>
          <group group_id="O1">
            <title>PJ STRATIS</title>
            <description>Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.&#xD;
AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.&#xD;
PJ STRATIS needle-free injection device</description>
          </group>
          <group group_id="O2">
            <title>Needle-Syringe</title>
            <description>Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.&#xD;
AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.&#xD;
Needle-Syringe</description>
          </group>
        </group_list>
        <measure>
          <title>Anti Influenza Type B Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT)</title>
          <description>The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio(GMT with NS / GMT with PJ Stratis) for each antigen to not exceed 1.5 fold.</description>
          <population>The immunogenicity analyses were conducted using data from subjects in the Immunogenicity Population.</population>
          <units>Titers</units>
          <param>Geometric Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="562"/>
                <count group_id="O2" value="568"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.60" spread="1.028"/>
                    <measurement group_id="O2" value="2.54" spread="1.003"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.75" spread="1.037"/>
                    <measurement group_id="O2" value="3.68" spread="1.061"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>For a sample size of 550 per group each test has an individual power of &gt; 99% to rule out the 1.5-fold difference using a two-sided α = 0.05, assuming equal GMTs between the two treatment groups. The overall power for the study to demonstrate the non-inferiority for the 6 co-primary endpoints is &gt; 80%, computed as product of 6 individual powers.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>The non-inferiority margin was defined as the upper bound of the two-sided 95% CI of the GMT ratio (GMT with NS / GMT with PJ Stratis) for each antigen did not exceed 1.5 fold.</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>0.94</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.83</ci_lower_limit>
            <ci_upper_limit>1.06</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Anti Influenza Type A/H1N1 Seroconversion</title>
        <description>Seroconversion is defined as a 4-fold rise in HAI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (&lt;1:10), attainment of a post-immunization titer of ≥1:40.</description>
        <time_frame>28 days</time_frame>
        <population>The immunogenicity analyses were conducted using data from subjects in the Immunogenicity Population.</population>
        <group_list>
          <group group_id="O1">
            <title>PJ STRATIS</title>
            <description>Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.&#xD;
AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.&#xD;
PJ STRATIS needle-free injection device</description>
          </group>
          <group group_id="O2">
            <title>Needle-Syringe</title>
            <description>Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.&#xD;
AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.&#xD;
Needle-Syringe</description>
          </group>
        </group_list>
        <measure>
          <title>Anti Influenza Type A/H1N1 Seroconversion</title>
          <description>Seroconversion is defined as a 4-fold rise in HAI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (&lt;1:10), attainment of a post-immunization titer of ≥1:40.</description>
          <population>The immunogenicity analyses were conducted using data from subjects in the Immunogenicity Population.</population>
          <units>Percent of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="562"/>
                <count group_id="O2" value="568"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.5"/>
                    <measurement group_id="O2" value="38.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>For a sample size of 550 per group each test has an individual power of &gt; 95% to rule out the 10 percentage points difference using a one-sided α = 0.025, assuming equal seroconversion rates between the two treatment groups. The overall power for the study to demonstrate the non-inferiority for the 6 co-primary endpoints is &gt; 80%, computed as product of 6 individual powers.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Seroconversion rate defined as the proportion of subjects with either a pre-vaccination titer of &lt;10 achieving a post-vaccination antibody of HI titer of ≥ 40 or with a pre-vaccination HI titer of ≥ 10 achieving a four-fold or greater increase in post-vaccination HI titer. The non-inferiority margin was defined as the upper bound of the two-sided 95% CI on the difference between the seroconversion rates (rate with NS - with PJ Stratis) for each vaccine strain did not exceed 10 percentage points.</non_inferiority_desc>
            <param_type>Seroconversion Rate Difference</param_type>
            <param_value>0.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.8</ci_lower_limit>
            <ci_upper_limit>6.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Anti Influenza Type A/H3N2 Seroconversion</title>
        <description>Seroconversion is defined as a 4-fold rise in HAI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (&lt;1:10), attainment of a post-immunization titer of ≥1:40.</description>
        <time_frame>28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>PJ STRATIS</title>
            <description>Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.&#xD;
AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.&#xD;
PJ STRATIS needle-free injection device</description>
          </group>
          <group group_id="O2">
            <title>Needle-Syringe</title>
            <description>Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.&#xD;
AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.&#xD;
Needle-Syringe</description>
          </group>
        </group_list>
        <measure>
          <title>Anti Influenza Type A/H3N2 Seroconversion</title>
          <description>Seroconversion is defined as a 4-fold rise in HAI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (&lt;1:10), attainment of a post-immunization titer of ≥1:40.</description>
          <units>Percent of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="562"/>
                <count group_id="O2" value="568"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.8"/>
                    <measurement group_id="O2" value="45.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>For a sample size of 550 per group each test has an individual power of &gt; 95% to rule out the 10 percentage points difference using a one-sided α = 0.025, assuming equal seroconversion rates between the two treatment groups. The overall power for the study to demonstrate the non-inferiority for the 6 co-primary endpoints is &gt; 80%, computed as product of 6 individual powers.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Seroconversion rate defined as the proportion of subjects with either a pre-vaccination titer of &lt;10 achieving a post-vaccination antibody of HI titer of ≥ 40 or with a pre-vaccination HI titer of ≥ 10 achieving a four-fold or greater increase in post-vaccination HI titer. The non-inferiority margin was defined as the upper bound of the two-sided 95% CI on the difference between the seroconversion rates(rate with NS - with PJ Stratis) for each vaccine strain did not exceed 10 percentage points</non_inferiority_desc>
            <param_type>Seroconversion Rate Difference</param_type>
            <param_value>1.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.5</ci_lower_limit>
            <ci_upper_limit>7.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Anti Influenza Type B Seroconversion</title>
        <description>Seroconversion is defined as a 4-fold rise in HAI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (&lt;1:10), attainment of a post-immunization titer of ≥1:40.</description>
        <time_frame>28 days</time_frame>
        <population>The immunogenicity analyses were conducted using data from subjects in the Immunogenicity Population.</population>
        <group_list>
          <group group_id="O1">
            <title>PJ STRATIS</title>
            <description>Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.&#xD;
AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.&#xD;
PJ STRATIS needle-free injection device</description>
          </group>
          <group group_id="O2">
            <title>Needle-Syringe</title>
            <description>Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.&#xD;
AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.&#xD;
Needle-Syringe</description>
          </group>
        </group_list>
        <measure>
          <title>Anti Influenza Type B Seroconversion</title>
          <description>Seroconversion is defined as a 4-fold rise in HAI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (&lt;1:10), attainment of a post-immunization titer of ≥1:40.</description>
          <population>The immunogenicity analyses were conducted using data from subjects in the Immunogenicity Population.</population>
          <units>Percent of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="562"/>
                <count group_id="O2" value="568"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.9"/>
                    <measurement group_id="O2" value="35.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>For a sample size of 550 per group each test has an individual power of &gt; 91% to rule out the 10 percentage points difference using a one-sided α = 0.025, assuming equal seroconversion rates between the two treatment groups. The overall power for the study to demonstrate the non-inferiority for the 6 co-primary endpoints is &gt; 80%, computed as product of 6 individual powers.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Seroconversion rate was defined as the proportion of subjects with either a pre-vaccination titer of &lt;10 achieving a post-vaccination antibody of HI titer of ≥ 40 or with a pre-vaccination HI titer of ≥ 10 achieving a four-fold or greater increase in post-vaccination HI titer.&#xD;
The upper-bound of the two-sided 95% CI on the difference in seroconversion rates for the A/H1N1, A/H3N2, and B strains did not exceed 10 percentage points (6.5, 7.1, and 5.9 respectively).</non_inferiority_desc>
            <param_type>Seroconversion Rate Difference</param_type>
            <param_value>0.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.2</ci_lower_limit>
            <ci_upper_limit>5.9</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Complaints Within 30 Minutes Following Vaccination</title>
        <time_frame>Within 30 minutes post-vaccination</time_frame>
        <population>The safety population included 1247 subjects (N=624 PJ Stratis, N=623 NS).</population>
        <group_list>
          <group group_id="O1">
            <title>PJ STRATIS</title>
            <description>Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.&#xD;
AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.&#xD;
PJ STRATIS needle-free injection device</description>
          </group>
          <group group_id="O2">
            <title>Needle-Syringe</title>
            <description>Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.&#xD;
AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.&#xD;
Needle-Syringe</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Complaints Within 30 Minutes Following Vaccination</title>
          <population>The safety population included 1247 subjects (N=624 PJ Stratis, N=623 NS).</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="624"/>
                <count group_id="O2" value="623"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="163"/>
                    <measurement group_id="O2" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tenderness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="104"/>
                    <measurement group_id="O2" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Itching</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Redness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="113"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bruising</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Immediate adverse events were reported within 30 minutes of receiving the vaccination; therefore, they are all considered related to study treatment.</non_inferiority_desc>
            <p_value>&lt;0.001</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Vaccine Reactogenicity Events</title>
        <description>Vaccine reactogenicity will be collected on a patient-completed diary card during checkout from Day 0 and on the next six evenings post-vaccination. The following adverse events will be solicited on the diary card: pain at injection site, tenderness at injection site, redness where the injection is given; induration/swelling (lump) where the injection is given; bruising where the injection is given; itching where the injection is given; headache; tiredness/fatigue (asthenia, lethargy, malaise); general muscle ache (myalgia); chills; nausea; vomiting. Subjects will also record their oral temperature on the diary card each evening.</description>
        <time_frame>Day 0, 1, 2, 3, 4, 5, and 6</time_frame>
        <population>The safety population included 1247 subjects (N=624 PJ Stratis, N=623 NS). Eight subjects (624-616) in the PJ Stratis group and 16 (623-607) in the NS group did not return the 7-Day Diary Card.</population>
        <group_list>
          <group group_id="O1">
            <title>PJ STRATIS</title>
            <description>Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.&#xD;
AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.&#xD;
PJ STRATIS needle-free injection device</description>
          </group>
          <group group_id="O2">
            <title>Needle-Syringe</title>
            <description>Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.&#xD;
AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.&#xD;
Needle-Syringe</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Vaccine Reactogenicity Events</title>
          <description>Vaccine reactogenicity will be collected on a patient-completed diary card during checkout from Day 0 and on the next six evenings post-vaccination. The following adverse events will be solicited on the diary card: pain at injection site, tenderness at injection site, redness where the injection is given; induration/swelling (lump) where the injection is given; bruising where the injection is given; itching where the injection is given; headache; tiredness/fatigue (asthenia, lethargy, malaise); general muscle ache (myalgia); chills; nausea; vomiting. Subjects will also record their oral temperature on the diary card each evening.</description>
          <population>The safety population included 1247 subjects (N=624 PJ Stratis, N=623 NS). Eight subjects (624-616) in the PJ Stratis group and 16 (623-607) in the NS group did not return the 7-Day Diary Card.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="616"/>
                <count group_id="O2" value="607"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="397"/>
                    <measurement group_id="O2" value="299"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tenderness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="551"/>
                    <measurement group_id="O2" value="472"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Itching</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="151"/>
                    <measurement group_id="O2" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Redness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="366"/>
                    <measurement group_id="O2" value="115"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="392"/>
                    <measurement group_id="O2" value="115"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bruising</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="107"/>
                    <measurement group_id="O2" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="151"/>
                    <measurement group_id="O2" value="133"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Malaise</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="191"/>
                    <measurement group_id="O2" value="171"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="222"/>
                    <measurement group_id="O2" value="214"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chills</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                    <measurement group_id="O2" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nausea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vomiting</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>The safety population included subjects who received the vaccination and for whom follow-up data were available for a specific safety analysis. Therefore, the denominators for different safety tables vary, depending on the availability of the data.</non_inferiority_desc>
            <p_value>&lt;0.001</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Spontaneously Reported Adverse Events</title>
        <description>Subjects will be asked to report any other symptoms experienced in addition to the solicited &quot;immediate&quot; and &quot;vaccine reactogenicity&quot; events. Any other events reported will be tabulated as spontaneously reported adverse events.</description>
        <time_frame>28 days</time_frame>
        <population>The safety population included 1247 subjects (N=624 PJ Stratis, N=623 NS).</population>
        <group_list>
          <group group_id="O1">
            <title>PJ STRATIS</title>
            <description>Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.&#xD;
AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.&#xD;
PJ STRATIS needle-free injection device</description>
          </group>
          <group group_id="O2">
            <title>Needle-Syringe</title>
            <description>Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.&#xD;
AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.&#xD;
Needle-Syringe</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Spontaneously Reported Adverse Events</title>
          <description>Subjects will be asked to report any other symptoms experienced in addition to the solicited &quot;immediate&quot; and &quot;vaccine reactogenicity&quot; events. Any other events reported will be tabulated as spontaneously reported adverse events.</description>
          <population>The safety population included 1247 subjects (N=624 PJ Stratis, N=623 NS).</population>
          <units>participants with spontaneous AEs</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="624"/>
                <count group_id="O2" value="623"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92"/>
                    <measurement group_id="O2" value="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects Who Received a PJ Stratis Injection Would Choose to Receive This Type of Injection Again</title>
        <time_frame>28 Days</time_frame>
        <population>Safety population</population>
        <group_list>
          <group group_id="O1">
            <title>PJ STRATIS</title>
            <description>Patients assigned to this arm will receive AFLURIA vaccine administered using the PJ STRATIS needle-free injection device.&#xD;
AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.&#xD;
PJ STRATIS needle-free injection device</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Who Received a PJ Stratis Injection Would Choose to Receive This Type of Injection Again</title>
          <population>Safety population</population>
          <units>Percent of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="624"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Immediate complaints were solicited from subjects in the safety population following vaccination: pain, tenderness, itching, redness, swelling, and bruising at the vaccination site.</time_frame>
      <desc>Solicited adverse events were those events specifically sought for and recorded by the subject in the 7-Day Diary Card.&#xD;
The denominators were determined for each individual AE for each summary window (Day 0-3 or 4-6). Subjects in Safety Populations were excluded from the denominator if there was no data captured for the AE within summary window.</desc>
      <group_list>
        <group group_id="E1">
          <title>STRATIS</title>
          <description>Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.&#xD;
AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.&#xD;
STRATIS needle-free injection device</description>
        </group>
        <group group_id="E2">
          <title>Needle-Syringe</title>
          <description>Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.&#xD;
AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.&#xD;
Needle-Syringe</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (14.0)</default_vocab>
        <default_assessment>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="1" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="623"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Coronary Artery Disease</sub_title>
                <description>The SAE reported was unrelated to the subject's participation in the study.</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="623"/>
              </event>
              <event>
                <sub_title>Myocardial Infarction</sub_title>
                <description>The SAE reported was unrelated to the subject's participation in the study.</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="623"/>
              </event>
              <event>
                <sub_title>Arterial Injury</sub_title>
                <description>The SAE reported was unrelated to the subject's participation in the study.</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="623"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Duodenal Ulcer Perforation</sub_title>
                <description>The SAE was unrelated to subject's participation in the study.</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="623"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Peritonitis</sub_title>
                <description>The SAE reported was unrelated to subject's participation in the study.</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="623"/>
              </event>
              <event>
                <sub_title>Viral Meningitis</sub_title>
                <description>The SAE reported was unrelated to the subject's participation in the study.</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="623"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (14.0)</default_vocab>
        <default_assessment>Non-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="586" subjects_at_risk="624"/>
                <counts group_id="E2" subjects_affected="516" subjects_at_risk="623"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="40" subjects_at_risk="610"/>
                <counts group_id="E2" subjects_affected="39" subjects_at_risk="601"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pain</sub_title>
                <description>Local symptoms at injection site within 6 days of vaccination with Grade of &gt;=1</description>
                <counts group_id="E1" subjects_affected="397" subjects_at_risk="616"/>
                <counts group_id="E2" subjects_affected="299" subjects_at_risk="606"/>
              </event>
              <event>
                <sub_title>Tenderness</sub_title>
                <description>Local Adverse Reaction within 6 days of vaccination and Grade of &gt;=1</description>
                <counts group_id="E1" subjects_affected="551" subjects_at_risk="616"/>
                <counts group_id="E2" subjects_affected="471" subjects_at_risk="606"/>
              </event>
              <event>
                <sub_title>Itching</sub_title>
                <description>Local Adverse Reaction occurring within 6 days of vaccination and a Grade of &gt;=1</description>
                <counts group_id="E1" subjects_affected="146" subjects_at_risk="540"/>
                <counts group_id="E2" subjects_affected="49" subjects_at_risk="527"/>
              </event>
              <event>
                <sub_title>Redness</sub_title>
                <description>Local event occurring within 6 days of vaccination and Grade of &gt;=1</description>
                <counts group_id="E1" subjects_affected="366" subjects_at_risk="609"/>
                <counts group_id="E2" subjects_affected="115" subjects_at_risk="599"/>
              </event>
              <event>
                <sub_title>Swelling</sub_title>
                <description>Local Adverse Reaction occurring within 6 days of vaccination with Grade level &gt;=1</description>
                <counts group_id="E1" subjects_affected="392" subjects_at_risk="605"/>
                <counts group_id="E2" subjects_affected="118" subjects_at_risk="599"/>
              </event>
              <event>
                <sub_title>Bruising</sub_title>
                <description>Local Adverse Reaction occurring within 6 days of vaccination with Grade level of &gt;=1</description>
                <counts group_id="E1" subjects_affected="104" subjects_at_risk="607"/>
                <counts group_id="E2" subjects_affected="30" subjects_at_risk="599"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Malaise</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="191" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="171" subjects_at_risk="602"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Myalgia</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="222" subjects_at_risk="610"/>
                <counts group_id="E2" subjects_affected="214" subjects_at_risk="602"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="151" subjects_at_risk="612"/>
                <counts group_id="E2" subjects_affected="133" subjects_at_risk="603"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="43" subjects_at_risk="610"/>
                <counts group_id="E2" subjects_affected="43" subjects_at_risk="601"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Tara Miller, Clinical Affairs Manager</name_or_title>
      <organization>PharmaJet, Inc.</organization>
      <phone>888-900-4321 ext 4163</phone>
      <email>tara.miller@pharmajet.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/NCT01688921
org study id: PJ-501-12-2
nct id: NCT01688921
lead sponsor: 
has dmc: No
The purpose of this study is to determine if the administration of a seasonal flu vaccine
      using a PharmaJet's needle-free injection device (STRATIS) is equivalent to needle and
      syringe administration, as measured by laboratory tests of immune response.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Anti Influenza Type A/H1N1 Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT)
time frame: 28 days
description: The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio(GMT with NS / GMT with PJ Stratis) for A/H1N1 antigen will not exceed 1.5 fold.
measure: Anti Influenza Type A/H2N3 Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT)
time frame: 28 days
description: The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio(GMT with NS / GMT with PJ Stratis) for each antigen to not exceed 1.5 fold.
measure: Anti Influenza Type B Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT)
time frame: 28 days
description: The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio(GMT with NS / GMT with PJ Stratis) for each antigen to not exceed 1.5 fold.
measure: Anti Influenza Type A/H1N1 Seroconversion
time frame: 28 days
description: Seroconversion is defined as a 4-fold rise in HAI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (<1:10), attainment of a post-immunization titer of ≥1:40.
measure: Anti Influenza Type A/H3N2 Seroconversion
time frame: 28 days
description: Seroconversion is defined as a 4-fold rise in HAI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (<1:10), attainment of a post-immunization titer of ≥1:40.
measure: Anti Influenza Type B Seroconversion
time frame: 28 days
description: Seroconversion is defined as a 4-fold rise in HAI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (<1:10), attainment of a post-immunization titer of ≥1:40.
measure: Number of Subjects With Complaints Within 30 Minutes Following Vaccination
time frame: Within 30 minutes post-vaccination
measure: Number of Subjects With Vaccine Reactogenicity Events
time frame: Day 0, 1, 2, 3, 4, 5, and 6
description: Vaccine reactogenicity will be collected on a patient-completed diary card during checkout from Day 0 and on the next six evenings post-vaccination. The following adverse events will be solicited on the diary card: pain at injection site, tenderness at injection site, redness where the injection is given; induration/swelling (lump) where the injection is given; bruising where the injection is given; itching where the injection is given; headache; tiredness/fatigue (asthenia, lethargy, malaise); general muscle ache (myalgia); chills; nausea; vomiting. Subjects will also record their oral temperature on the diary card each evening.
measure: Number of Subjects With Spontaneously Reported Adverse Events
time frame: 28 days
description: Subjects will be asked to report any other symptoms experienced in addition to the solicited "immediate" and "vaccine reactogenicity" events. Any other events reported will be tabulated as spontaneously reported adverse events.
measure: Percentage of Subjects Who Received a PJ Stratis Injection Would Choose to Receive This Type of Injection Again
time frame: 28 Days
arm group label: STRATIS Needle-Free
arm group type: Experimental
description: Patients assigned to this arm will receive AFLURIA vaccine administered using the Stratis needle-free injection device.
arm group label: Needle-Syringe
arm group type: Active Comparator
description: Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.
intervention type: Biological
intervention name: AFLURIA vaccine (2012-2013 formulation)
description: Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.
arm group label: Needle-Syringe
arm group label: STRATIS Needle-Free
other name: trivalent inactivated influenza vaccine (TIV)
other name: influenza virus vaccine
intervention type: Device
intervention name: Needle-Syringe
arm group label: Needle-Syringe
arm group label: STRATIS Needle-Free
intervention type: Device
intervention name: Stratis needle-free injection device
arm group label: Needle-Syringe
arm group label: STRATIS Needle-Free
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: Accepts Healthy Volunteers
last name: David K Cobb, MD, MPH
role: Principal Investigator
affiliation: Rocky Mountain Infectious Disease Consultants
last name: Linda McAllister, MD, PhD
role: Study Director
affiliation: PharmaJet, Inc.
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Influenza, Human
mesh term: Vaccines
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 