<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/NCT01682876</url>
  </required_header>
  <id_info>
    <org_study_id>205238</org_study_id>
    <secondary_id>V59_57</secondary_id>
    <secondary_id>2011-004421-27</secondary_id>
    <nct_id>NCT01682876</nct_id>
  </id_info>
  <brief_title>Immunogenicity, Safety and 1 Year Persistence of Antibodies After Either One or Two Doses of Meningococcal ACWY Conjugate Vaccine in Healthy Children 2 Through 10 Years of Age.</brief_title>
  <official_title>A Phase 3b, Randomized, Observer-Blind, Placebo-Controlled Multi-Center Study Comparing Immunogenicity, Safety and 1 Year Persistence of Antibodies After Either One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine, Administered to Healthy Children 2 to 10 Years of Age.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study was designed to conduct a comparative trial to further evaluate the safety,&#xD;
      immunogenicity and antibody persistence of two doses of Novartis MenACWY conjugate vaccine,&#xD;
      given 2 months apart, versus one dose of Novartis MenACWY conjugate vaccine in children 2&#xD;
      through 10 years of age.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 7, 2012</start_date>
  <completion_date type="Actual">May 30, 2014</completion_date>
  <primary_completion_date type="Actual">July 2, 2013</primary_completion_date>
  <phase>Phase 3</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>Non-inferiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination</measure>
    <time_frame>One Month After Last Vaccination ( day 86)</time_frame>
    <description>Immunogenicity was measured as the percentage of subjects with overall seroresponse and associated 2-sided 97.5% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y, by serum bactericidal assay using human complement (hSBA) at 1 month after one vaccination or two vaccinations of MenACWY-CRM given two months apart. Seroresponse is defined as: a. postvaccination hSBA titer ≥1:8 for subjects with a prevaccination hSBA titer &lt;1:4; b. for subjects with a prevaccination hSBA ≥1:4, an increase of at least four times of the prevaccination hSBA titer.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Superiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination</measure>
    <time_frame>One Month After Last Vaccination (day 86)</time_frame>
    <description>Immunogenicity was measured as the percentage of subjects with overall seroresponse and associated 2-sided 95% CI, directed against N. meningitidis serogroups A, C, W and Y, by hSBA at 1 month after one vaccination or two vaccinations of MenACWY-CRM. Seroresponse -postvaccination hSBA titer ≥1:8 for subjects with a prevaccination hSBA titer &lt;1:4 and for subjects with a prevaccination hSBA ≥1:4, an increase of at least four times of the prevaccination hSBA titer.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM</measure>
    <time_frame>One Month After Last Vaccination (day 86)</time_frame>
    <description>Immunogenicity was measured as the percentage of subjects who achieved hSBA titer ≥1:8 and associated 95% CI, at one month after one vaccination or two vaccinations of MenACWY-CRM.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM</measure>
    <time_frame>One Month After Last Vaccination (day 86)</time_frame>
    <description>Immunogenicity was measured as hSBA geometric mean titers (GMTs) and 95% CI against N. meningitidis serogroups A, C, W and Y, one month after one vaccination or two vaccinations of MenACWY-CRM.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM</measure>
    <time_frame>One year after one vaccination or two vaccinations (day 422).</time_frame>
    <description>Immunogenicity was measured as the percentage of subjects with hSBA titer ≥1:8 and associated 95% CI at one year after one vaccination or two vaccinations of MenACWY-CRM.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM</measure>
    <time_frame>One year after one vaccination or two vaccinations (day 422).</time_frame>
    <description>Immunogenicity was measured as hSBA GMTs and 95% CI against N. meningitidis serogroups A, C, W and Y at one year after one vaccination or two vaccinations of MenACWY-CRM.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of 2 to 5 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination</measure>
    <time_frame>From Days 1-7 after each vaccination</time_frame>
    <description>Safety was assessed as the number of 2 to 5 years-old subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after one or two vaccination(s) of MenACWY-CRM</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numbers of 6 to 10 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination</measure>
    <time_frame>From Days 1-7 after each vaccination</time_frame>
    <description>Safety was assessed as the number of 6 to 10 years-old subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after one or two vaccination(s) of MenACWY-CRM</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Who Reported Selected AEs After Any Vaccination</measure>
    <time_frame>Day 1 to Day 86</time_frame>
    <description>Safety was assessed as the number subjects who reported Selected AEs from day 1 up to day 86 after one or two vaccination(s) of MenACWY-CRM</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Who Reported Selected AEs After Any Vaccination</measure>
    <time_frame>Day 1 to Day 422</time_frame>
    <description>Safety was assessed as the number subjects who reported Selected AEs from day 1 up to day 422 after one or two vaccination(s) of MenACWY-CRM</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">715</enrollment>
  <condition>Meningococcal Disease</condition>
  <condition>Infections, Meningococcal</condition>
  <arm_group>
    <arm_group_label>2 through 5 years (1 Vac) MenACWY-CRM 1</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects 2 through 5 years received one vaccination of MenACWY-CRM</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2 through 5 years (2 Vac) MenACWY-CRM 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects 2 through 5 years received two vaccinations of MenACWY-CRM</description>
  </arm_group>
  <arm_group>
    <arm_group_label>6 through 10 years (1 Vac) MenACWY-CRM 3</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects 6 through 10 years received one vaccination of MenACWY-CRM</description>
  </arm_group>
  <arm_group>
    <arm_group_label>6 through 10 years (2 Vac) MenACWY-CRM 4</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects 6 through 10 years received two vaccinations of MenACWY-CRM</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>MenACWY-CRM</intervention_name>
    <description>The investigational meningococcal (groups A, C, Y, and W-135 vaccine) oligosaccharide diphtheria CRM197 conjugate vaccine (MenACWY-CRM) was administered intramuscularly in the nondominant arm</description>
    <arm_group_label>2 through 5 years (1 Vac) MenACWY-CRM 1</arm_group_label>
    <arm_group_label>2 through 5 years (2 Vac) MenACWY-CRM 2</arm_group_label>
    <arm_group_label>6 through 10 years (1 Vac) MenACWY-CRM 3</arm_group_label>
    <arm_group_label>6 through 10 years (2 Vac) MenACWY-CRM 4</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy children, 2 to 10 years of age who have up to date routine childhood&#xD;
             vaccination, according to U.S. ACIP recommendations&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Unwilling or unable to give written informed assent or consent to participate in the&#xD;
             study.&#xD;
&#xD;
          2. Perceived to be unreliable or unavailable for the duration of the study period.&#xD;
&#xD;
          3. Previous confirmed or suspected disease caused by N. meningitidis.&#xD;
&#xD;
          4. Previously immunized with a meningococcal vaccine (licensed or investigational).&#xD;
&#xD;
          5. Receipt of any investigational or non-registered product within 30 days prior to&#xD;
             enrolment or who expect to receive an investigational drug or vaccine prior to the&#xD;
             completion of the study.&#xD;
&#xD;
          6. Receipt or plan to receive any vaccines within 30 days before and after administration&#xD;
             of each dose of the study vaccine.&#xD;
&#xD;
             (certain exceptions influenza vaccines apply)&#xD;
&#xD;
          7. Significant acute infection within the 7 days prior to enrolment or body temperature&#xD;
             of 38°C or greater within 3 days prior to enrolment.&#xD;
&#xD;
          8. Previous serious acute, chronic or progressive disease, epilepsy or any progressive&#xD;
             neurological disease or history of Guillain-Barre syndrome.&#xD;
&#xD;
          9. History of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine&#xD;
             components&#xD;
&#xD;
         10. Impairment/alteration of immune function, either congenital or acquired or resulting&#xD;
             from (for example):&#xD;
&#xD;
               -  receipt of immunosuppressive therapy,&#xD;
&#xD;
               -  receipt of immunostimulants,&#xD;
&#xD;
               -  receipt of parenteral immunoglobulin preparation, blood products, and/or plasma&#xD;
                  derivatives.&#xD;
&#xD;
         11. Known bleeding diathesis, or any condition that may be associated with a prolonged&#xD;
             bleeding time.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95822</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Lake Mary</city>
        <state>Florida</state>
        <zip>32746</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30062</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Woodstock</city>
        <state>Georgia</state>
        <zip>30189</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Council Bluffs</city>
        <state>Iowa</state>
        <zip>51503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40291</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Metairie</city>
        <state>Louisiana</state>
        <zip>70006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Niles</city>
        <state>Michigan</state>
        <zip>49120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Stevensville</city>
        <state>Michigan</state>
        <zip>49127</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bellevue</city>
        <state>Nebraska</state>
        <zip>68005</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Fremont</city>
        <state>Nebraska</state>
        <zip>68025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Johnson City</city>
        <state>New York</state>
        <zip>13790</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>West Jordan</city>
        <state>Utah</state>
        <zip>84088</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>September 7, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2012</study_first_posted>
  <results_first_submitted>June 6, 2014</results_first_submitted>
  <results_first_submitted_qc>September 29, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">October 6, 2014</results_first_posted>
  <last_update_submitted>June 13, 2019</last_update_submitted>
  <last_update_submitted_qc>June 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prevention of meningococcal disease, children, vaccine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Meningococcal Infections</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were enrolled at 22 locations</recruitment_details>
      <pre_assignment_details>All enrolled subjects were included in the trial.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>2 Through 5 Years (2 Vac)</title>
          <description>Subjects 2-5 years of age received two MenACWY-CRM vaccinations</description>
        </group>
        <group group_id="P2">
          <title>2 Through 5 Years (1 Vac)</title>
          <description>Subjects 2-5 years of age received one MenACWY-CRM vaccination</description>
        </group>
        <group group_id="P3">
          <title>6 Through 10 Years (2 Vac)</title>
          <description>Subjects 6-10 years of age received two MenACWY-CRM vaccinations</description>
        </group>
        <group group_id="P4">
          <title>6 Through 10 Years (1 Vac)</title>
          <description>Subjects 6-10 years of age received one MenACWY-CRM vaccination</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="176"/>
                <participants group_id="P2" count="183"/>
                <participants group_id="P3" count="180"/>
                <participants group_id="P4" count="176"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="155"/>
                <participants group_id="P2" count="163"/>
                <participants group_id="P3" count="169"/>
                <participants group_id="P4" count="157"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="20"/>
                <participants group_id="P3" count="11"/>
                <participants group_id="P4" count="19"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Administrative reason</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>2 Through 5 Years (2 Vac)</title>
          <description>Subjects 2-5 years of age received two MenACWY-CRM vaccinations</description>
        </group>
        <group group_id="B2">
          <title>2 Through 5 Years (1 Vac)</title>
          <description>Subjects 2-5 years of age received one MenACWY-CRM vaccination</description>
        </group>
        <group group_id="B3">
          <title>6 Through 10 Years (2 Vac)</title>
          <description>Subjects 6-10 years of age received two MenACWY-CRM vaccinations</description>
        </group>
        <group group_id="B4">
          <title>6 Through 10 Years (1 Vac)</title>
          <description>Subjects 6-10 years of age received one MenACWY-CRM vaccination</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="176"/>
            <count group_id="B2" value="183"/>
            <count group_id="B3" value="180"/>
            <count group_id="B4" value="176"/>
            <count group_id="B5" value="715"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>year</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.5" spread="1.1"/>
                    <measurement group_id="B2" value="3.6" spread="1.2"/>
                    <measurement group_id="B3" value="7.8" spread="1.4"/>
                    <measurement group_id="B4" value="7.8" spread="1.4"/>
                    <measurement group_id="B5" value="5.7" spread="2.5"/>
                  </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="84"/>
                    <measurement group_id="B2" value="88"/>
                    <measurement group_id="B3" value="97"/>
                    <measurement group_id="B4" value="87"/>
                    <measurement group_id="B5" value="356"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="92"/>
                    <measurement group_id="B2" value="95"/>
                    <measurement group_id="B3" value="83"/>
                    <measurement group_id="B4" value="89"/>
                    <measurement group_id="B5" value="359"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Non-inferiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination</title>
        <description>Immunogenicity was measured as the percentage of subjects with overall seroresponse and associated 2-sided 97.5% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y, by serum bactericidal assay using human complement (hSBA) at 1 month after one vaccination or two vaccinations of MenACWY-CRM given two months apart. Seroresponse is defined as: a. postvaccination hSBA titer ≥1:8 for subjects with a prevaccination hSBA titer &lt;1:4; b. for subjects with a prevaccination hSBA ≥1:4, an increase of at least four times of the prevaccination hSBA titer.</description>
        <time_frame>One Month After Last Vaccination ( day 86)</time_frame>
        <population>Analysis was done on the primary per-protocol (PP) dataset, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>2 Through 5 Years (2 Vac)</title>
            <description>Subjects 2-5 years of age received two MenACWY-CRM vaccinations</description>
          </group>
          <group group_id="O2">
            <title>2 Through 5 Years (1 Vac)</title>
            <description>Subjects 2-5 years of age received one MenACWY-CRM vaccination</description>
          </group>
          <group group_id="O3">
            <title>6 Through 10 Years (2 Vac)</title>
            <description>Subjects 6-10 years of age received two MenACWY-CRM vaccinations</description>
          </group>
          <group group_id="O4">
            <title>6 Through 10 Years (1 Vac)</title>
            <description>Subjects 6-10 years of age received one MenACWY-CRM vaccination</description>
          </group>
        </group_list>
        <measure>
          <title>Non-inferiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination</title>
          <description>Immunogenicity was measured as the percentage of subjects with overall seroresponse and associated 2-sided 97.5% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y, by serum bactericidal assay using human complement (hSBA) at 1 month after one vaccination or two vaccinations of MenACWY-CRM given two months apart. Seroresponse is defined as: a. postvaccination hSBA titer ≥1:8 for subjects with a prevaccination hSBA titer &lt;1:4; b. for subjects with a prevaccination hSBA ≥1:4, an increase of at least four times of the prevaccination hSBA titer.</description>
          <population>Analysis was done on the primary per-protocol (PP) dataset, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="136"/>
                <count group_id="O2" value="144"/>
                <count group_id="O3" value="153"/>
                <count group_id="O4" value="142"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>MenA(N=135,143,152,142)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94" lower_limit="89" upper_limit="97"/>
                    <measurement group_id="O2" value="75" lower_limit="67" upper_limit="82"/>
                    <measurement group_id="O3" value="89" lower_limit="83" upper_limit="93"/>
                    <measurement group_id="O4" value="77" lower_limit="70" upper_limit="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MenC(N=131,140,149,142)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92" lower_limit="86" upper_limit="96"/>
                    <measurement group_id="O2" value="65" lower_limit="56" upper_limit="73"/>
                    <measurement group_id="O3" value="93" lower_limit="87" upper_limit="96"/>
                    <measurement group_id="O4" value="73" lower_limit="65" upper_limit="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MenW(N=128,135,148,138)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75" lower_limit="67" upper_limit="82"/>
                    <measurement group_id="O2" value="61" lower_limit="52" upper_limit="69"/>
                    <measurement group_id="O3" value="58" lower_limit="50" upper_limit="66"/>
                    <measurement group_id="O4" value="54" lower_limit="45" upper_limit="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MenY(N=128,133,148,142)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91" lower_limit="84" upper_limit="95"/>
                    <measurement group_id="O2" value="64" lower_limit="55" upper_limit="72"/>
                    <measurement group_id="O3" value="89" lower_limit="83" upper_limit="94"/>
                    <measurement group_id="O4" value="60" lower_limit="51" upper_limit="68"/>
                  </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>Non-inferiority of seroresponse of two vaccinations vs.one vaccination for age cohort (2 to 5 years of age) for MenA</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Noninferiority was demonstrated for 2 to 5 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenA</non_inferiority_desc>
            <param_type>Vaccine Group Differences at Day 86</param_type>
            <param_value>19</param_value>
            <ci_percent>97.5</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>10</ci_lower_limit>
            <ci_upper_limit>28.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (2 to 5 years of age) for MenC</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Noninferiority was demonstrated for 2 to 5 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenC</non_inferiority_desc>
            <param_type>Vaccine Group Differences at Day 86</param_type>
            <param_value>27</param_value>
            <ci_percent>97.5</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>16.9</ci_lower_limit>
            <ci_upper_limit>37.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (2 to 5 years of age) for MenW</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Noninferiority was demonstrated for 2 to 5 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenW</non_inferiority_desc>
            <param_type>Vaccine Group Differences at Day 86</param_type>
            <param_value>14</param_value>
            <ci_percent>97.5</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.4</ci_lower_limit>
            <ci_upper_limit>26.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (2 to 5 years of age) for MenY</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Noninferiority was demonstrated for 2 to 5 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for Men Y</non_inferiority_desc>
            <param_type>Vaccine Group differences at Day 86</param_type>
            <param_value>27</param_value>
            <ci_percent>97.5</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>15.6</ci_lower_limit>
            <ci_upper_limit>37.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (6 to 10 years of age) for MenA</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Noninferiority was demonstrated for 6 to 10 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenA</non_inferiority_desc>
            <param_type>Vaccines Group Differences at Day 86</param_type>
            <param_value>11</param_value>
            <ci_percent>97.5</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.7</ci_lower_limit>
            <ci_upper_limit>21.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (6 to 10 years of age) for MenC</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Noninferiority was demonstrated for 6 to 10 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenC</non_inferiority_desc>
            <param_type>Vaccines Group differences at Day 86</param_type>
            <param_value>19</param_value>
            <ci_percent>97.5</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>9.9</ci_lower_limit>
            <ci_upper_limit>29.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (6 to 10 years of age) for MenW</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Noninferiority was demonstrated for 6 to 10 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenW</non_inferiority_desc>
            <param_type>Vaccines Group Differences at Day 86</param_type>
            <param_value>4</param_value>
            <ci_percent>97.5</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.6</ci_lower_limit>
            <ci_upper_limit>17.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Non-inferiority of seroresponse for two vaccinations vs. one vaccination for age cohort (6 to 10 years of age) for MenY</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Noninferiority was demonstrated for 6 to 10 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenY</non_inferiority_desc>
            <param_type>Vaccines Group Differences at Day 86</param_type>
            <param_value>29</param_value>
            <ci_percent>97.5</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>18.4</ci_lower_limit>
            <ci_upper_limit>40</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Superiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination</title>
        <description>Immunogenicity was measured as the percentage of subjects with overall seroresponse and associated 2-sided 95% CI, directed against N. meningitidis serogroups A, C, W and Y, by hSBA at 1 month after one vaccination or two vaccinations of MenACWY-CRM. Seroresponse -postvaccination hSBA titer ≥1:8 for subjects with a prevaccination hSBA titer &lt;1:4 and for subjects with a prevaccination hSBA ≥1:4, an increase of at least four times of the prevaccination hSBA titer.</description>
        <time_frame>One Month After Last Vaccination (day 86)</time_frame>
        <population>Analysis was done on the FAS dataset - All subjects in the exposed dataset who provided evaluable serum samples whose assay results were available for at least 1 serogroup on day 1 and 1 post baseline visit.</population>
        <group_list>
          <group group_id="O1">
            <title>2 Through 5 Years (2 Vac)</title>
            <description>Subjects 2-5 years of age received two MenACWY-CRM vaccinations</description>
          </group>
          <group group_id="O2">
            <title>2 Through 5 Years (1 Vac)</title>
            <description>Subjects 2-5 years of age received one MenACWY-CRM vaccination</description>
          </group>
          <group group_id="O3">
            <title>6 Through 10 Years (2 Vac)</title>
            <description>Subjects 6-10 years of age received two MenACWY-CRM vaccinations</description>
          </group>
          <group group_id="O4">
            <title>6 Through 10 Years (1 Vac)</title>
            <description>Subjects 6-10 years of age received one MenACWY-CRM vaccination</description>
          </group>
        </group_list>
        <measure>
          <title>Superiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination</title>
          <description>Immunogenicity was measured as the percentage of subjects with overall seroresponse and associated 2-sided 95% CI, directed against N. meningitidis serogroups A, C, W and Y, by hSBA at 1 month after one vaccination or two vaccinations of MenACWY-CRM. Seroresponse -postvaccination hSBA titer ≥1:8 for subjects with a prevaccination hSBA titer &lt;1:4 and for subjects with a prevaccination hSBA ≥1:4, an increase of at least four times of the prevaccination hSBA titer.</description>
          <population>Analysis was done on the FAS dataset - All subjects in the exposed dataset who provided evaluable serum samples whose assay results were available for at least 1 serogroup on day 1 and 1 post baseline visit.</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="159"/>
                <count group_id="O2" value="165"/>
                <count group_id="O3" value="172"/>
                <count group_id="O4" value="163"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>MenA(N=158,163,171,163)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95" lower_limit="90" upper_limit="98"/>
                    <measurement group_id="O2" value="77" lower_limit="69" upper_limit="83"/>
                    <measurement group_id="O3" value="89" lower_limit="84" upper_limit="94"/>
                    <measurement group_id="O4" value="79" lower_limit="71" upper_limit="85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MenC(N=154,157,167,162)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93" lower_limit="88" upper_limit="96"/>
                    <measurement group_id="O2" value="65" lower_limit="57" upper_limit="72"/>
                    <measurement group_id="O3" value="93" lower_limit="89" upper_limit="97"/>
                    <measurement group_id="O4" value="75" lower_limit="68" upper_limit="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MenW(N=150,154,167,159)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75" lower_limit="68" upper_limit="82"/>
                    <measurement group_id="O2" value="61" lower_limit="53" upper_limit="69"/>
                    <measurement group_id="O3" value="57" lower_limit="49" upper_limit="65"/>
                    <measurement group_id="O4" value="52" lower_limit="44" upper_limit="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MenY(N=150,153,167,163)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90" lower_limit="84" upper_limit="94"/>
                    <measurement group_id="O2" value="62" lower_limit="54" upper_limit="70"/>
                    <measurement group_id="O3" value="89" lower_limit="83" upper_limit="93"/>
                    <measurement group_id="O4" value="60" lower_limit="52" upper_limit="68"/>
                  </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>Superiority for age cohort (2 through 5 years of age) for MenA was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenA</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Vaccine Group Differences at Day 86</param_type>
            <param_value>18</param_value>
            <ci_percent>98.75</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>9.1</ci_lower_limit>
            <ci_upper_limit>28</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Superiority for age cohort (2 through 5 years of age) for MenC was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenC</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Vaccine Group Differences at Day 86</param_type>
            <param_value>28</param_value>
            <ci_percent>98.75</ci_percent>
            <ci_lower_limit>17.1</ci_lower_limit>
            <ci_upper_limit>38.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Superiority for age cohort (2 through 5 years of age) for MenW was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenW</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Vaccine Group differences at Day 86</param_type>
            <param_value>14</param_value>
            <ci_percent>98.75</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1</ci_lower_limit>
            <ci_upper_limit>27.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Superiority for age cohort (2 through 5 years of age) for MenY was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenY</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Vaccine groups Differences at Day 86</param_type>
            <param_value>28</param_value>
            <ci_percent>98.75</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>16.2</ci_lower_limit>
            <ci_upper_limit>39.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Superiority for age cohort (6 through 10 years of age) for MenA was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenA</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Vaccine groups differences at Day 86</param_type>
            <param_value>11</param_value>
            <ci_percent>98.75</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1</ci_lower_limit>
            <ci_upper_limit>21.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Superiority for age cohort (6 through 10 years of age) for MenC was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenC</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Vaccine Group differences at Day 86</param_type>
            <param_value>18</param_value>
            <ci_percent>97.5</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>9.5</ci_lower_limit>
            <ci_upper_limit>27.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Superiority for age cohort (6 through 10 years of age) for MenW was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenW</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Vaccine Group Differences at Day 86</param_type>
            <param_value>5</param_value>
            <ci_percent>98.75</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.4</ci_lower_limit>
            <ci_upper_limit>18.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Superiority for age cohort (6 through 10 years of age) for MenY was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenY</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Vaccine group Differences at Day 86</param_type>
            <param_value>29</param_value>
            <ci_percent>98.75</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>17</ci_lower_limit>
            <ci_upper_limit>39.6</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM</title>
        <description>Immunogenicity was measured as the percentage of subjects who achieved hSBA titer ≥1:8 and associated 95% CI, at one month after one vaccination or two vaccinations of MenACWY-CRM.</description>
        <time_frame>One Month After Last Vaccination (day 86)</time_frame>
        <population>Analysis was done on the primary PP dataset.</population>
        <group_list>
          <group group_id="O1">
            <title>2 Through 5 Years (2 Vac)</title>
            <description>Subjects 2-5 years of age received two MenACWY-CRM vaccinations</description>
          </group>
          <group group_id="O2">
            <title>2 Through 5 Years (1 Vac)</title>
            <description>Subjects 2-5 years of age received one MenACWY-CRM vaccination</description>
          </group>
          <group group_id="O3">
            <title>6 Through 10 Years (2 Vac)</title>
            <description>Subjects 6-10 years of age received two MenACWY-CRM vaccinations</description>
          </group>
          <group group_id="O4">
            <title>6 Through 10 Years (1 Vac)</title>
            <description>Subjects 6-10 years of age received one MenACWY-CRM vaccination</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM</title>
          <description>Immunogenicity was measured as the percentage of subjects who achieved hSBA titer ≥1:8 and associated 95% CI, at one month after one vaccination or two vaccinations of MenACWY-CRM.</description>
          <population>Analysis was done on the primary PP dataset.</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="136"/>
                <count group_id="O2" value="144"/>
                <count group_id="O3" value="153"/>
                <count group_id="O4" value="142"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>MenA(N=135,143,152,142)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95" lower_limit="90" upper_limit="98"/>
                    <measurement group_id="O2" value="76" lower_limit="68" upper_limit="82"/>
                    <measurement group_id="O3" value="91" lower_limit="85" upper_limit="95"/>
                    <measurement group_id="O4" value="80" lower_limit="73" upper_limit="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MenC(N=131,140,149,142)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98" lower_limit="95" upper_limit="100"/>
                    <measurement group_id="O2" value="76" lower_limit="68" upper_limit="83"/>
                    <measurement group_id="O3" value="99" lower_limit="95" upper_limit="100"/>
                    <measurement group_id="O4" value="89" lower_limit="82" upper_limit="93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MenW(N=128,135,148,138)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99" lower_limit="96" upper_limit="100"/>
                    <measurement group_id="O2" value="92" lower_limit="86" upper_limit="96"/>
                    <measurement group_id="O3" value="99" lower_limit="96" upper_limit="100"/>
                    <measurement group_id="O4" value="96" lower_limit="91" upper_limit="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MenY(N=128,133,148,142)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96" lower_limit="91" upper_limit="99"/>
                    <measurement group_id="O2" value="69" lower_limit="61" upper_limit="77"/>
                    <measurement group_id="O3" value="96" lower_limit="91" upper_limit="98"/>
                    <measurement group_id="O4" value="73" lower_limit="64" upper_limit="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM</title>
        <description>Immunogenicity was measured as hSBA geometric mean titers (GMTs) and 95% CI against N. meningitidis serogroups A, C, W and Y, one month after one vaccination or two vaccinations of MenACWY-CRM.</description>
        <time_frame>One Month After Last Vaccination (day 86)</time_frame>
        <population>Analysis was done on the primary PP dataset</population>
        <group_list>
          <group group_id="O1">
            <title>2 Through 5 Years (2 Vac)</title>
            <description>Subjects 2-5 years of age received two MenACWY-CRM vaccinations</description>
          </group>
          <group group_id="O2">
            <title>2 Through 5 Years (1 Vac)</title>
            <description>Subjects 2-5 years of age received one MenACWY-CRM vaccination</description>
          </group>
          <group group_id="O3">
            <title>6 Through 10 Years (2 Vac)</title>
            <description>Subjects 6-10 years of age received two MenACWY-CRM vaccinations</description>
          </group>
          <group group_id="O4">
            <title>6 Through 10 Years (1 Vac)</title>
            <description>Subjects 6-10 years of age received one MenACWY-CRM vaccination</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM</title>
          <description>Immunogenicity was measured as hSBA geometric mean titers (GMTs) and 95% CI against N. meningitidis serogroups A, C, W and Y, one month after one vaccination or two vaccinations of MenACWY-CRM.</description>
          <population>Analysis was done on the primary PP dataset</population>
          <units>Titer</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="136"/>
                <count group_id="O2" value="144"/>
                <count group_id="O3" value="153"/>
                <count group_id="O4" value="142"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>MenA(N=135,143,152,142)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68" lower_limit="54" upper_limit="86"/>
                    <measurement group_id="O2" value="21" lower_limit="17" upper_limit="27"/>
                    <measurement group_id="O3" value="67" lower_limit="52" upper_limit="87"/>
                    <measurement group_id="O4" value="36" lower_limit="28" upper_limit="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MenC(N=131,140,149,142)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="146" lower_limit="115" upper_limit="186"/>
                    <measurement group_id="O2" value="22" lower_limit="18" upper_limit="28"/>
                    <measurement group_id="O3" value="165" lower_limit="126" upper_limit="217"/>
                    <measurement group_id="O4" value="67" lower_limit="51" upper_limit="89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MenW(N=128,135,148,138)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="191" lower_limit="150" upper_limit="243"/>
                    <measurement group_id="O2" value="104" lower_limit="83" upper_limit="132"/>
                    <measurement group_id="O3" value="169" lower_limit="138" upper_limit="206"/>
                    <measurement group_id="O4" value="95" lower_limit="78" upper_limit="117"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MenY(N=128,133,148,142)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70" lower_limit="55" upper_limit="90"/>
                    <measurement group_id="O2" value="15" lower_limit="12" upper_limit="19"/>
                    <measurement group_id="O3" value="76" lower_limit="58" upper_limit="99"/>
                    <measurement group_id="O4" value="26" lower_limit="20" upper_limit="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM</title>
        <description>Immunogenicity was measured as the percentage of subjects with hSBA titer ≥1:8 and associated 95% CI at one year after one vaccination or two vaccinations of MenACWY-CRM.</description>
        <time_frame>One year after one vaccination or two vaccinations (day 422).</time_frame>
        <population>Analysis was done on the persistence PP dataset</population>
        <group_list>
          <group group_id="O1">
            <title>2 Through 5 Years (2 Vac)</title>
            <description>Subjects 2-5 years of age received two MenACWY-CRM vaccinations</description>
          </group>
          <group group_id="O2">
            <title>2 Through 5 Years (1 Vac)</title>
            <description>Subjects 2-5 years of age received one MenACWY-CRM vaccination</description>
          </group>
          <group group_id="O3">
            <title>6 Through 10 Years (2 Vac)</title>
            <description>Subjects 6-10 years of age received two MenACWY-CRM vaccinations</description>
          </group>
          <group group_id="O4">
            <title>6 Through 10 Years (1 Vac)</title>
            <description>Subjects 6-10 years of age received one MenACWY-CRM vaccination</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM</title>
          <description>Immunogenicity was measured as the percentage of subjects with hSBA titer ≥1:8 and associated 95% CI at one year after one vaccination or two vaccinations of MenACWY-CRM.</description>
          <population>Analysis was done on the persistence PP dataset</population>
          <units>percentages of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="136"/>
                <count group_id="O2" value="144"/>
                <count group_id="O3" value="153"/>
                <count group_id="O4" value="142"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>MenA(N=122,131,142,130)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30" lower_limit="22" upper_limit="39"/>
                    <measurement group_id="O2" value="11" lower_limit="6" upper_limit="17"/>
                    <measurement group_id="O3" value="30" lower_limit="22" upper_limit="38"/>
                    <measurement group_id="O4" value="20" lower_limit="14" upper_limit="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MenC(N=123,128,141,130)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61" lower_limit="52" upper_limit="70"/>
                    <measurement group_id="O2" value="41" lower_limit="32" upper_limit="50"/>
                    <measurement group_id="O3" value="81" lower_limit="73" upper_limit="87"/>
                    <measurement group_id="O4" value="55" lower_limit="46" upper_limit="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MenW(N=121,127,139,130)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92" lower_limit="85" upper_limit="96"/>
                    <measurement group_id="O2" value="91" lower_limit="84" upper_limit="95"/>
                    <measurement group_id="O3" value="94" lower_limit="89" upper_limit="97"/>
                    <measurement group_id="O4" value="90" lower_limit="84" upper_limit="95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MenY(N=121,122,140,130)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67" lower_limit="58" upper_limit="75"/>
                    <measurement group_id="O2" value="57" lower_limit="48" upper_limit="66"/>
                    <measurement group_id="O3" value="75" lower_limit="67" upper_limit="82"/>
                    <measurement group_id="O4" value="65" lower_limit="57" upper_limit="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM</title>
        <description>Immunogenicity was measured as hSBA GMTs and 95% CI against N. meningitidis serogroups A, C, W and Y at one year after one vaccination or two vaccinations of MenACWY-CRM.</description>
        <time_frame>One year after one vaccination or two vaccinations (day 422).</time_frame>
        <population>Analysis was done on the persistence PP dataset</population>
        <group_list>
          <group group_id="O1">
            <title>2 Through 5 Years (2 Vac)</title>
            <description>Subjects 2-5 years of age received two MenACWY-CRM vaccinations</description>
          </group>
          <group group_id="O2">
            <title>2 Through 5 Years (1 Vac)</title>
            <description>Subjects 2-5 years of age received one MenACWY-CRM vaccination</description>
          </group>
          <group group_id="O3">
            <title>6 Through 10 Years (2 Vac)</title>
            <description>Subjects 6-10 years of age received two MenACWY-CRM vaccinations</description>
          </group>
          <group group_id="O4">
            <title>6 Through 10 Years (1 Vac)</title>
            <description>Subjects 6-10 years of age received one MenACWY-CRM vaccination</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM</title>
          <description>Immunogenicity was measured as hSBA GMTs and 95% CI against N. meningitidis serogroups A, C, W and Y at one year after one vaccination or two vaccinations of MenACWY-CRM.</description>
          <population>Analysis was done on the persistence PP dataset</population>
          <units>Titers</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="136"/>
                <count group_id="O2" value="144"/>
                <count group_id="O3" value="153"/>
                <count group_id="O4" value="142"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>MenA(N=122,131,142,130)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.72" lower_limit="3.91" upper_limit="5.71"/>
                    <measurement group_id="O2" value="2.66" lower_limit="2.22" upper_limit="3.19"/>
                    <measurement group_id="O3" value="4.66" lower_limit="3.75" upper_limit="5.81"/>
                    <measurement group_id="O4" value="3.56" lower_limit="2.84" upper_limit="4.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MenC(N=123,128,141,130)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10" lower_limit="8.34" upper_limit="13"/>
                    <measurement group_id="O2" value="7.03" lower_limit="5.63" upper_limit="8.76"/>
                    <measurement group_id="O3" value="24" lower_limit="18" upper_limit="31"/>
                    <measurement group_id="O4" value="15" lower_limit="12" upper_limit="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MenW(N=121,127,139,130)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49" lower_limit="39" upper_limit="62"/>
                    <measurement group_id="O2" value="39" lower_limit="31" upper_limit="49"/>
                    <measurement group_id="O3" value="64" lower_limit="52" upper_limit="79"/>
                    <measurement group_id="O4" value="47" lower_limit="38" upper_limit="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MenY(N=121,122,140,130)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14" lower_limit="11" upper_limit="17"/>
                    <measurement group_id="O2" value="9.88" lower_limit="7.8" upper_limit="13"/>
                    <measurement group_id="O3" value="20" lower_limit="15" upper_limit="25"/>
                    <measurement group_id="O4" value="13" lower_limit="9.96" upper_limit="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of 2 to 5 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination</title>
        <description>Safety was assessed as the number of 2 to 5 years-old subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after one or two vaccination(s) of MenACWY-CRM</description>
        <time_frame>From Days 1-7 after each vaccination</time_frame>
        <population>Analysis was done on the safety dataset i.e. the subjects in the exposed population who provided postvaccination safety data.</population>
        <group_list>
          <group group_id="O1">
            <title>2 Through 5 Years (2 Vac)</title>
            <description>Subjects 2-5 years of age received two MenACWY-CRM vaccinations</description>
          </group>
          <group group_id="O2">
            <title>2 Through 5 Years (1 Vac)</title>
            <description>Subjects 2-5 years of age received one MenACWY-CRM vaccination</description>
          </group>
        </group_list>
        <measure>
          <title>Number of 2 to 5 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination</title>
          <description>Safety was assessed as the number of 2 to 5 years-old subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after one or two vaccination(s) of MenACWY-CRM</description>
          <population>Analysis was done on the safety dataset i.e. the subjects in the exposed population who provided postvaccination safety data.</population>
          <units>subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="176"/>
                <count group_id="O2" value="182"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Erythema(N=173,175)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Induration(N=173,175)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tenderness (N=174,175)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84"/>
                    <measurement group_id="O2" value="79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change in Eating Habits(N=173,175)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sleepiness(N=173,175)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49"/>
                    <measurement group_id="O2" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Irritability(N=173,175)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51"/>
                    <measurement group_id="O2" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Body Temperature &gt;=38.0(N=174,175)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced erythema in the two doses versus in the one dose of MenACWY-CRM</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>2.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.17</ci_lower_limit>
            <ci_upper_limit>4.53</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced induration in the two doses versus in the one dose of MenACWY-CRM</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>2.75</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.18</ci_lower_limit>
            <ci_upper_limit>6.36</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced tenderness in the two doses versus in the one dose of MenACWY-CRM</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>1.07</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.85</ci_lower_limit>
            <ci_upper_limit>1.34</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced change in eating habits in the two doses versus in the one dose of MenACWY-CRM</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>0.88</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.54</ci_lower_limit>
            <ci_upper_limit>1.42</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced sleepiness in the two doses versus in the one dose of MenACWY-CRM</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>1.08</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.76</ci_lower_limit>
            <ci_upper_limit>1.52</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced irritability in the two doses versus in the one dose of MenACWY-CRM</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>1.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.74</ci_lower_limit>
            <ci_upper_limit>1.43</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced fever (≥38 °C) in the two doses versus in the one dose of MenACWY-CRM</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>0.75</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.33</ci_lower_limit>
            <ci_upper_limit>1.74</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Numbers of 6 to 10 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination</title>
        <description>Safety was assessed as the number of 6 to 10 years-old subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after one or two vaccination(s) of MenACWY-CRM</description>
        <time_frame>From Days 1-7 after each vaccination</time_frame>
        <population>Analysis was done on the safety dataset</population>
        <group_list>
          <group group_id="O1">
            <title>6 Through 10 Years (2 Vac)</title>
            <description>Subjects 6-10 years of age received two MenACWY-CRM vaccinations</description>
          </group>
          <group group_id="O2">
            <title>6 Through 10 Years (1 Vac)</title>
            <description>Subjects 6-10 years of age received one MenACWY-CRM vaccination</description>
          </group>
        </group_list>
        <measure>
          <title>Numbers of 6 to 10 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination</title>
          <description>Safety was assessed as the number of 6 to 10 years-old subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after one or two vaccination(s) of MenACWY-CRM</description>
          <population>Analysis was done on the safety dataset</population>
          <units>Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="180"/>
                <count group_id="O2" value="175"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Erythema(N=178,166)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Induration(N=178,166)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain(N=178,166)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="106"/>
                    <measurement group_id="O2" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Loss of Appetite(N=177,166)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nausea(N=177,165)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue(N=177,166)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia(N=177,165)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63"/>
                    <measurement group_id="O2" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Arthralgia(N=177,165)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache(N=177,165)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55"/>
                    <measurement group_id="O2" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Body Temperature&gt;=38.0(N=178,166)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="9"/>
                  </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>The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced erythema in the two doses versus in the one dose of MenACWY-CRM</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>1.43</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.77</ci_lower_limit>
            <ci_upper_limit>2.65</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced induration in the two doses versus in the one dose of MenACWY-CRM</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>1.49</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.81</ci_lower_limit>
            <ci_upper_limit>2.74</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced pain in the two doses versus in the one dose of MenACWY-CRM</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>1.27</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.04</ci_lower_limit>
            <ci_upper_limit>1.55</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced loss of appetite in the two doses versus in the one dose of MenACWY-CRM</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>1.81</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.98</ci_lower_limit>
            <ci_upper_limit>3.33</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced nausea in the two doses versus in the one dose of MenACWY-CRM</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>1.29</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.77</ci_lower_limit>
            <ci_upper_limit>2.17</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced fatigue in the two doses versus in the one dose of MenACWY-CRM</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>1.65</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.06</ci_lower_limit>
            <ci_upper_limit>2.57</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced myalgia in the two doses versus in the one dose of MenACWY-CRM</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>1.37</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.99</ci_lower_limit>
            <ci_upper_limit>1.89</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced arthralgia in the two doses versus in the one dose of MenACWY-CRM</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>2.07</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.97</ci_lower_limit>
            <ci_upper_limit>4.42</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced headache in the two doses versus in the one dose of MenACWY-CRM</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>1.83</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.22</ci_lower_limit>
            <ci_upper_limit>2.74</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced fever (≥38 °C) in the two doses versus in the one dose of MenACWY-CRM</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>1.14</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.48</ci_lower_limit>
            <ci_upper_limit>2.68</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Who Reported Selected AEs After Any Vaccination</title>
        <description>Safety was assessed as the number subjects who reported Selected AEs from day 1 up to day 86 after one or two vaccination(s) of MenACWY-CRM</description>
        <time_frame>Day 1 to Day 86</time_frame>
        <population>Analysis was done on Safety Set Unsolicited AEs</population>
        <group_list>
          <group group_id="O1">
            <title>2 Through 5 Years (2 Vac)</title>
            <description>Subjects 2-5 years of age received two MenACWY-CRM vaccinations</description>
          </group>
          <group group_id="O2">
            <title>2 Through 5 Years (1 Vac)</title>
            <description>Subjects 2-5 years of age received one MenACWY-CRM vaccination</description>
          </group>
          <group group_id="O3">
            <title>6 Through 10 Years (2 Vac)</title>
            <description>Subjects 6-10 years of age received two MenACWY-CRM vaccinations</description>
          </group>
          <group group_id="O4">
            <title>6 Through 10 Years (1 Vac)</title>
            <description>Subjects 6-10 years of age received one MenACWY-CRM vaccination</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Who Reported Selected AEs After Any Vaccination</title>
          <description>Safety was assessed as the number subjects who reported Selected AEs from day 1 up to day 86 after one or two vaccination(s) of MenACWY-CRM</description>
          <population>Analysis was done on Safety Set Unsolicited AEs</population>
          <units>Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="179"/>
                <count group_id="O2" value="179"/>
                <count group_id="O3" value="181"/>
                <count group_id="O4" value="174"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <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>At least possibly related SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Medically attended AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50"/>
                    <measurement group_id="O2" value="55"/>
                    <measurement group_id="O3" value="46"/>
                    <measurement group_id="O4" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least possibly related medically attended AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AEs resulting in premature withdrawal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Deaths</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Who Reported Selected AEs After Any Vaccination</title>
        <description>Safety was assessed as the number subjects who reported Selected AEs from day 1 up to day 422 after one or two vaccination(s) of MenACWY-CRM</description>
        <time_frame>Day 1 to Day 422</time_frame>
        <population>Analysis was done on safety set</population>
        <group_list>
          <group group_id="O1">
            <title>2 Through 5 Years (2 Vac)</title>
            <description>Subjects 2-5 years of age received two MenACWY-CRM vaccinations</description>
          </group>
          <group group_id="O2">
            <title>2 Through 5 Years (1 Vac)</title>
            <description>Subjects 2-5 years of age received one MenACWY-CRM vaccination</description>
          </group>
          <group group_id="O3">
            <title>6 Through 10 Years (2 Vac)</title>
            <description>Subjects 6-10 years of age received two MenACWY-CRM vaccinations</description>
          </group>
          <group group_id="O4">
            <title>6 Through 10 Years (1 Vac)</title>
            <description>Subjects 6-10 years of age received one MenACWY-CRM vaccination</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Who Reported Selected AEs After Any Vaccination</title>
          <description>Safety was assessed as the number subjects who reported Selected AEs from day 1 up to day 422 after one or two vaccination(s) of MenACWY-CRM</description>
          <population>Analysis was done on safety set</population>
          <units>Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="179"/>
                <count group_id="O2" value="179"/>
                <count group_id="O3" value="181"/>
                <count group_id="O4" value="174"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Medically attended AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="103"/>
                    <measurement group_id="O2" value="101"/>
                    <measurement group_id="O3" value="95"/>
                    <measurement group_id="O4" value="97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least possibly related medically attended AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AEs resulting in premature withdrawal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Deaths</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Throughout study period</time_frame>
      <desc>Serious adverse events (SAEs) were collected from day 1 to study termination/early termination.</desc>
      <group_list>
        <group group_id="E1">
          <title>2 Through 5 Years (2 Vac)</title>
          <description>Subjects 2-5 years of age received two MenACWY-CRM vaccinations</description>
        </group>
        <group group_id="E2">
          <title>2 Through 5 Years (1 Vac)</title>
          <description>Subjects 2-5 years of age received one MenACWY-CRM vaccination</description>
        </group>
        <group group_id="E3">
          <title>6 Through 10 Years (2 Vac)</title>
          <description>Subjects 6-10 years of age received two MenACWY-CRM vaccinations</description>
        </group>
        <group group_id="E4">
          <title>6 Through 10 Years (1 Vac)</title>
          <description>Subjects 6-10 years of age received one MenACWY-CRM vaccination</description>
        </group>
        <group group_id="E5">
          <title>Total</title>
          <description>Total Population</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 15.0v</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="2" subjects_at_risk="179"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="174"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="713"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>IMMUNE THROMBOCYTOPENIC PURPURA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="713"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>OTITIS MEDIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="713"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>DEHYDRATION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="713"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>PETIT MAL EPILEPSY</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="713"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>INTERMITTENT EXPLOSIVE DISORDER</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="174"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="713"/>
              </event>
              <event>
                <sub_title>OPPOSITIONAL DEFIANT DISORDER</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="174"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="713"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>ASTHMA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="713"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>DERMATITIS ALLERGIC</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="713"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 15.0v</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="148" subjects_at_risk="179"/>
                <counts group_id="E2" subjects_affected="142" subjects_at_risk="179"/>
                <counts group_id="E3" subjects_affected="153" subjects_at_risk="181"/>
                <counts group_id="E4" subjects_affected="133" subjects_at_risk="174"/>
                <counts group_id="E5" subjects_affected="576" subjects_at_risk="713"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>ABDOMINAL PAIN UPPER</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="179"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="179"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="181"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="174"/>
                <counts group_id="E5" subjects_affected="24" subjects_at_risk="713"/>
              </event>
              <event>
                <sub_title>DIARRHOEA</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="179"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="179"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="181"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="174"/>
                <counts group_id="E5" subjects_affected="28" subjects_at_risk="713"/>
              </event>
              <event>
                <sub_title>NAUSEA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E3" subjects_affected="29" subjects_at_risk="181"/>
                <counts group_id="E4" subjects_affected="23" subjects_at_risk="174"/>
                <counts group_id="E5" subjects_affected="52" subjects_at_risk="713"/>
              </event>
              <event>
                <sub_title>VOMITING</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="179"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="179"/>
                <counts group_id="E3" subjects_affected="15" subjects_at_risk="181"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="174"/>
                <counts group_id="E5" subjects_affected="64" subjects_at_risk="713"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>FATIGUE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E3" subjects_affected="47" subjects_at_risk="181"/>
                <counts group_id="E4" subjects_affected="32" subjects_at_risk="174"/>
                <counts group_id="E5" subjects_affected="81" subjects_at_risk="713"/>
              </event>
              <event>
                <sub_title>INJECTION SITE ERYTHEMA</sub_title>
                <counts group_id="E1" subjects_affected="71" subjects_at_risk="179"/>
                <counts group_id="E2" subjects_affected="48" subjects_at_risk="179"/>
                <counts group_id="E3" subjects_affected="64" subjects_at_risk="181"/>
                <counts group_id="E4" subjects_affected="49" subjects_at_risk="174"/>
                <counts group_id="E5" subjects_affected="232" subjects_at_risk="713"/>
              </event>
              <event>
                <sub_title>INJECTION SITE INDURATION</sub_title>
                <counts group_id="E1" subjects_affected="54" subjects_at_risk="179"/>
                <counts group_id="E2" subjects_affected="39" subjects_at_risk="179"/>
                <counts group_id="E3" subjects_affected="60" subjects_at_risk="181"/>
                <counts group_id="E4" subjects_affected="40" subjects_at_risk="174"/>
                <counts group_id="E5" subjects_affected="193" subjects_at_risk="713"/>
              </event>
              <event>
                <sub_title>INJECTION SITE PAIN</sub_title>
                <counts group_id="E1" subjects_affected="93" subjects_at_risk="179"/>
                <counts group_id="E2" subjects_affected="91" subjects_at_risk="179"/>
                <counts group_id="E3" subjects_affected="120" subjects_at_risk="181"/>
                <counts group_id="E4" subjects_affected="88" subjects_at_risk="174"/>
                <counts group_id="E5" subjects_affected="392" subjects_at_risk="713"/>
              </event>
              <event>
                <sub_title>PYREXIA</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="179"/>
                <counts group_id="E2" subjects_affected="34" subjects_at_risk="179"/>
                <counts group_id="E3" subjects_affected="26" subjects_at_risk="181"/>
                <counts group_id="E4" subjects_affected="26" subjects_at_risk="174"/>
                <counts group_id="E5" subjects_affected="115" subjects_at_risk="713"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>CONJUNCTIVITIS</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="179"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="179"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="174"/>
                <counts group_id="E5" subjects_affected="22" subjects_at_risk="713"/>
              </event>
              <event>
                <sub_title>EAR INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="179"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="179"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="181"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="174"/>
                <counts group_id="E5" subjects_affected="29" subjects_at_risk="713"/>
              </event>
              <event>
                <sub_title>NASOPHARYNGITIS</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="179"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="179"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="181"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="174"/>
                <counts group_id="E5" subjects_affected="21" subjects_at_risk="713"/>
              </event>
              <event>
                <sub_title>OTITIS MEDIA</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="179"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="179"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="181"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="174"/>
                <counts group_id="E5" subjects_affected="58" subjects_at_risk="713"/>
              </event>
              <event>
                <sub_title>PHARYNGITIS</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="179"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="179"/>
                <counts group_id="E3" subjects_affected="18" subjects_at_risk="181"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="174"/>
                <counts group_id="E5" subjects_affected="56" subjects_at_risk="713"/>
              </event>
              <event>
                <sub_title>PHARYNGITIS STREPTOCOCCAL</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="179"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="179"/>
                <counts group_id="E3" subjects_affected="17" subjects_at_risk="181"/>
                <counts group_id="E4" subjects_affected="14" subjects_at_risk="174"/>
                <counts group_id="E5" subjects_affected="61" subjects_at_risk="713"/>
              </event>
              <event>
                <sub_title>SINUSITIS</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="179"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="179"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="181"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="174"/>
                <counts group_id="E5" subjects_affected="34" subjects_at_risk="713"/>
              </event>
              <event>
                <sub_title>UPPER RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="179"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="179"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="181"/>
                <counts group_id="E4" subjects_affected="16" subjects_at_risk="174"/>
                <counts group_id="E5" subjects_affected="72" subjects_at_risk="713"/>
              </event>
              <event>
                <sub_title>VIRAL INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="179"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="179"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="181"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="174"/>
                <counts group_id="E5" subjects_affected="33" subjects_at_risk="713"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>DECREASED APPETITE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E3" subjects_affected="27" subjects_at_risk="181"/>
                <counts group_id="E4" subjects_affected="16" subjects_at_risk="174"/>
                <counts group_id="E5" subjects_affected="45" subjects_at_risk="713"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>ARTHRALGIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E3" subjects_affected="22" subjects_at_risk="181"/>
                <counts group_id="E4" subjects_affected="13" subjects_at_risk="174"/>
                <counts group_id="E5" subjects_affected="35" subjects_at_risk="713"/>
              </event>
              <event>
                <sub_title>MYALGIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E3" subjects_affected="66" subjects_at_risk="181"/>
                <counts group_id="E4" subjects_affected="48" subjects_at_risk="174"/>
                <counts group_id="E5" subjects_affected="114" subjects_at_risk="713"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>HEADACHE</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="179"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="179"/>
                <counts group_id="E3" subjects_affected="62" subjects_at_risk="181"/>
                <counts group_id="E4" subjects_affected="38" subjects_at_risk="174"/>
                <counts group_id="E5" subjects_affected="114" subjects_at_risk="713"/>
              </event>
              <event>
                <sub_title>SOMNOLENCE</sub_title>
                <counts group_id="E1" subjects_affected="54" subjects_at_risk="179"/>
                <counts group_id="E2" subjects_affected="48" subjects_at_risk="179"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="174"/>
                <counts group_id="E5" subjects_affected="103" subjects_at_risk="713"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>EATING DISORDER</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="179"/>
                <counts group_id="E2" subjects_affected="30" subjects_at_risk="179"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="181"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E5" subjects_affected="56" subjects_at_risk="713"/>
              </event>
              <event>
                <sub_title>IRRITABILITY</sub_title>
                <counts group_id="E1" subjects_affected="55" subjects_at_risk="179"/>
                <counts group_id="E2" subjects_affected="51" subjects_at_risk="179"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="181"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="174"/>
                <counts group_id="E5" subjects_affected="108" subjects_at_risk="713"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>COUGH</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="179"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="179"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="181"/>
                <counts group_id="E4" subjects_affected="15" subjects_at_risk="174"/>
                <counts group_id="E5" subjects_affected="66" subjects_at_risk="713"/>
              </event>
              <event>
                <sub_title>RHINITIS ALLERGIC</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="179"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="179"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="181"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="174"/>
                <counts group_id="E5" subjects_affected="16" subjects_at_risk="713"/>
              </event>
              <event>
                <sub_title>RHINORRHOEA</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="179"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="179"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="181"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="174"/>
                <counts group_id="E5" subjects_affected="31" subjects_at_risk="713"/>
              </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>GSK Response Center</name_or_title>
      <organization>GlaxoSmithKline</organization>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.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/NCT01682876
org study id: 205238
secondary id: V59_57
secondary id: 2011-004421-27
nct id: NCT01682876
lead sponsor: 
has dmc: No
This study was designed to conduct a comparative trial to further evaluate the safety,
      immunogenicity and antibody persistence of two doses of Novartis MenACWY conjugate vaccine,
      given 2 months apart, versus one dose of Novartis MenACWY conjugate vaccine in children 2
      through 10 years of age.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Non-inferiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination
time frame: One Month After Last Vaccination ( day 86)
description: Immunogenicity was measured as the percentage of subjects with overall seroresponse and associated 2-sided 97.5% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y, by serum bactericidal assay using human complement (hSBA) at 1 month after one vaccination or two vaccinations of MenACWY-CRM given two months apart. Seroresponse is defined as: a. postvaccination hSBA titer ≥1:8 for subjects with a prevaccination hSBA titer <1:4; b. for subjects with a prevaccination hSBA ≥1:4, an increase of at least four times of the prevaccination hSBA titer.
measure: Superiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination
time frame: One Month After Last Vaccination (day 86)
description: Immunogenicity was measured as the percentage of subjects with overall seroresponse and associated 2-sided 95% CI, directed against N. meningitidis serogroups A, C, W and Y, by hSBA at 1 month after one vaccination or two vaccinations of MenACWY-CRM. Seroresponse -postvaccination hSBA titer ≥1:8 for subjects with a prevaccination hSBA titer <1:4 and for subjects with a prevaccination hSBA ≥1:4, an increase of at least four times of the prevaccination hSBA titer.
measure: Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM
time frame: One Month After Last Vaccination (day 86)
description: Immunogenicity was measured as the percentage of subjects who achieved hSBA titer ≥1:8 and associated 95% CI, at one month after one vaccination or two vaccinations of MenACWY-CRM.
measure: Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM
time frame: One Month After Last Vaccination (day 86)
description: Immunogenicity was measured as hSBA geometric mean titers (GMTs) and 95% CI against N. meningitidis serogroups A, C, W and Y, one month after one vaccination or two vaccinations of MenACWY-CRM.
measure: Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM
time frame: One year after one vaccination or two vaccinations (day 422).
description: Immunogenicity was measured as the percentage of subjects with hSBA titer ≥1:8 and associated 95% CI at one year after one vaccination or two vaccinations of MenACWY-CRM.
measure: Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM
time frame: One year after one vaccination or two vaccinations (day 422).
description: Immunogenicity was measured as hSBA GMTs and 95% CI against N. meningitidis serogroups A, C, W and Y at one year after one vaccination or two vaccinations of MenACWY-CRM.
measure: Number of 2 to 5 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
time frame: From Days 1-7 after each vaccination
description: Safety was assessed as the number of 2 to 5 years-old subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after one or two vaccination(s) of MenACWY-CRM
measure: Numbers of 6 to 10 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
time frame: From Days 1-7 after each vaccination
description: Safety was assessed as the number of 6 to 10 years-old subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after one or two vaccination(s) of MenACWY-CRM
measure: Number of Subjects Who Reported Selected AEs After Any Vaccination
time frame: Day 1 to Day 86
description: Safety was assessed as the number subjects who reported Selected AEs from day 1 up to day 86 after one or two vaccination(s) of MenACWY-CRM
measure: Number of Subjects Who Reported Selected AEs After Any Vaccination
time frame: Day 1 to Day 422
description: Safety was assessed as the number subjects who reported Selected AEs from day 1 up to day 422 after one or two vaccination(s) of MenACWY-CRM
arm group label: 2 through 5 years (1 Vac) MenACWY-CRM 1
arm group type: Placebo Comparator
description: Subjects 2 through 5 years received one vaccination of MenACWY-CRM
arm group label: 2 through 5 years (2 Vac) MenACWY-CRM 2
arm group type: Active Comparator
description: Subjects 2 through 5 years received two vaccinations of MenACWY-CRM
arm group label: 6 through 10 years (1 Vac) MenACWY-CRM 3
arm group type: Placebo Comparator
description: Subjects 6 through 10 years received one vaccination of MenACWY-CRM
arm group label: 6 through 10 years (2 Vac) MenACWY-CRM 4
arm group type: Active Comparator
description: Subjects 6 through 10 years received two vaccinations of MenACWY-CRM
intervention type: Biological
intervention name: MenACWY-CRM
description: The investigational meningococcal (groups A, C, Y, and W-135 vaccine) oligosaccharide diphtheria CRM197 conjugate vaccine (MenACWY-CRM) was administered intramuscularly in the nondominant arm
arm group label: 2 through 5 years (1 Vac) MenACWY-CRM 1
arm group label: 2 through 5 years (2 Vac) MenACWY-CRM 2
arm group label: 6 through 10 years (1 Vac) MenACWY-CRM 3
arm group label: 6 through 10 years (2 Vac) MenACWY-CRM 4
criteria: 
gender: All
minimum age: 2 Years
maximum age: 10 Years
healthy volunteers: Accepts Healthy Volunteers
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
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country: United States
responsible party type: Sponsor
mesh term: Meningococcal Infections
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 