<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/NCT02986854</url>
  </required_header>
  <id_info>
    <org_study_id>205352</org_study_id>
    <secondary_id>V59_77</secondary_id>
    <secondary_id>2016-003186-25</secondary_id>
    <nct_id>NCT02986854</nct_id>
  </id_info>
  <brief_title>Study to Assess the Safety and Immunogenicity of a Single Dose of GlaxoSmithKline's (GSK) Meningococcal MenACWY-CRM Vaccine (Menveo), Administered to Subjects 15 Through 55 Years of Age, Approximately 4-6 Years After Primary ACWY Vaccination</brief_title>
  <official_title>A Phase 3b, Controlled, Open-Label, Multi-Center Study to Evaluate Safety and Immunogenicity of a Single Dose of GlaxoSmithKline's Meningococcal ACWY Conjugate Vaccine (Menveo), Administered to Healthy Individuals 15 Through 55 Years of Age, Approximately 4-6 Years After Primary ACWY Vaccination</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose/aim of this study is to assess the safety and antibody response to vaccination&#xD;
      with a booster dose of Menveo given 4-6 years after primary MenACWY vaccination and to assess&#xD;
      the safety and antibody response to a single dose of Menveo given to vaccine-naïve subjects&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a phase 3b, controlled, open-label, multi-center study to evaluate safety and&#xD;
      immunogenicity of Menveo after a single vaccination in healthy individuals who were&#xD;
      vaccinated with Menveo or Menactra 4 to 6 years before and in vaccine-naive individuals.&#xD;
      Vaccine-naive subjects: subjects who have not received any meningococcal vaccine prior to&#xD;
      participation to this clinical trial.&#xD;
&#xD;
      Subjects will be randomised into one of the two different blood draw schedules according to a&#xD;
      1:1 ratio.&#xD;
&#xD;
        -  Blood draws at Day 1, Day 4 and Day 29&#xD;
&#xD;
        -  Blood draws at Day 1, Day 6 and Day 29&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 8, 2016</start_date>
  <completion_date type="Actual">December 7, 2017</completion_date>
  <primary_completion_date type="Actual">July 17, 2017</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y.</measure>
    <time_frame>At Day 29</time_frame>
    <description>Seroresponse was defined as follows:for subjects with pre-vaccination hSBA titers&lt; 4,postvaccination hSBA titers≥16;for subjects with pre-vaccination hSBA titers≥4,post vaccination hSBA titers of atleast 4 times the pre-vaccination titers.Criteria to demonstrate primary objectives:Immune response sufficiency was tested sequentially;first in the group of subjects who received primary vaccination with Menveo &amp;,if met,also in group of subjects who received primary vaccination with Menactra.Immune response is considered sufficient if lower limit of the 1-sided 97.5% CI for percentage of subjects with hSBA seroresponse against serogroups A, C, W &amp; Y is greater than 75%.Study is considered successful if immune response sufficiency is demonstrated atleast in group of subjects who received primary vaccination with Menveo.This outcome measure was assessed only on subjects from Menveo-Menveo &amp; Menactra-Menveo groups.Data from pooled and Naive groups are presented as part of secondary objectives</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)</measure>
    <time_frame>Within 30 minutes after vaccination</time_frame>
    <description>An AE can be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom , or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product. An unsolicited adverse event is an adverse event that was not solicited using a subject diary and that was spontaneously communicated by a subject and/or parent(s)/legal guardian(s) who has signed the informed consent.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Solicited Local and Systemic AEs</measure>
    <time_frame>From Day 1 (6 hours) through Day 7 after vaccination</time_frame>
    <description>Assessed solicited local symptoms were injection site pain, erythema, induration. Assessed solicited systemic symptoms were fatigue, headache, myalgia, arthralgia, loss of appetite, nausea, chills and fever [defined and measured by a body temperature ≥37.5 degrees Celsius (ºC)]. Threshold for Erythema and Induration: Grade 0 (&lt;25 mm), Any (&gt;= 25 mm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Other Indicators of Reactogenicity</measure>
    <time_frame>From Day 1 (6 hours) through Day 7 after vaccination</time_frame>
    <description>Assessed indicators of reactogenicity were use of analgesics/antipyretics for prophylaxis, use of analgesics/antipyretics for treatment, body temperature (described as 0.5 °C increments from ≥ 36.0ºC)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting All Unsolicited AEs</measure>
    <time_frame>From Day 1 through Day 29 after vaccination</time_frame>
    <description>An AE can be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom , or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product. An unsolicited adverse event was an adverse event that was not solicited using a subject diary and that was spontaneously communicated by a subject and/or parent(s)/legal guardian(s) who has signed the informed consent.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Medically-attended AEs (MAAEs), AEs Leading to Withdrawal and Serious AEs (SAEs)</measure>
    <time_frame>From Day 1 through Day 181 (entire study period)</time_frame>
    <description>Medically attended AEs were defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider.&#xD;
SAE was defined as any untoward medical occurrence that at any dose resulted in: death, was life-threatening, required or prolonged hospitalization, persistent or significant disability/incapacity, congenital anomaly/or birth defect, an important and significant medical event that might not have been immediately life threatening or resulting in death or hospitalization but, based upon appropriate medical judgment, might jeopardized the subject or might required intervention to prevent one of the other outcomes listed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup A</measure>
    <time_frame>At Day 1 (pre-vaccination), Day 4, Day 6 and Day 29</time_frame>
    <description>For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup C</measure>
    <time_frame>At day 1(pre-vaccination) , day 4, day 6 and day 29</time_frame>
    <description>For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup W</measure>
    <time_frame>At day 1(pre-vaccination), day 4, day 6 and day 29</time_frame>
    <description>For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup Y</measure>
    <time_frame>At day 1(pre-vaccination), day 4, day 6 and day 29</time_frame>
    <description>For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup A</measure>
    <time_frame>At day 1(pre-vaccination), day 4, day 6 and day 29</time_frame>
    <description>For each study group and in the pooled group, percentages of subjects with hSBA titer ≥16 and associated two-sided 95%CIs were calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup C</measure>
    <time_frame>At day 1(pre-vaccination) , day 4, day 6 and day 29</time_frame>
    <description>Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup W</measure>
    <time_frame>At day 1(pre-vaccination), day 4, day 6 and day 29</time_frame>
    <description>For each study group and in the pooled group, percentages of subjects with hSBA titer ≥16 and associated two-sided 95%CIs were calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup Y</measure>
    <time_frame>At day 1(pre-vaccination) , day 4, day 6 and day 29</time_frame>
    <description>For each study group and in the pooled group, percentages of subjects with hSBA titer ≥16 and associated two-sided 95%CIs were calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y</measure>
    <time_frame>At Day 4 and Day 6</time_frame>
    <description>Seroresponse is defined for this study as follows: For subjects with pre-vaccination titers &lt;4, postvaccination titers ≥ 16; for subjects with pre-vaccination titers ≥4, post vaccination titers at least 4 times the pre-vaccination titers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y.</measure>
    <time_frame>At Day 1 (pre-vaccination), Day 4, Day 6 and Day 29</time_frame>
    <description>For each N. meningitidis serogroup A, C, W and Y, unadjusted GMTs were calculated, with their associated two-sided 95% Confidence Interval.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Within Group hSBA Geometric Mean Ratios (GMRs)</measure>
    <time_frame>At Day 4, Day 6, Day 29 compared to Day 1</time_frame>
    <description>Within each study group and for each serogroup, GMRs were calculated,at: Visit Day 4 versus at Visit Day 1; Visit Day 6 versus at Visit Day 1; and Visit Day 29 versus at Visit Day 1. The unadjusted GMRs and 95% CIs are constructed by exponentiating the mean within-group differences in log-transformed titers and the corresponding 95% CIs.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">704</enrollment>
  <condition>Infections, Meningococcal</condition>
  <arm_group>
    <arm_group_label>Menveo-Menveo Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Approximately 300 subjects, who were vaccinated with a single dose of Menveo 4 to 6 years before, will receive one dose of MenACWY-CRM at Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Menactra-Menveo Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Approximately 300 subjects, who were vaccinated with a single dose of Menactra 4 to 6 years before, will receive one dose of MenACWY-CRM at Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Naive Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Aproximately 100 subjects, of similar age to subjects enrolled in other primed groups, who have not received any meningococcal vaccination, will receive one dose of MenACWY-CRM at Day 1.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Meningococcal (groups A, C, W and Y) oligosaccharide diphtheria CRM-197 conjugate Vaccine (Menveo)</intervention_name>
    <description>One intramuscular injection of MenACWY at Day 1.</description>
    <arm_group_label>Menactra-Menveo Group</arm_group_label>
    <arm_group_label>Menveo-Menveo Group</arm_group_label>
    <arm_group_label>Naive Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Individuals of 15 through 55 years of age on the day of informed consent or assent.&#xD;
&#xD;
          2. Individuals who received Menveo 4 to 6 years prior to enrolment at an age of 11 years&#xD;
             or older OR Individuals who received Menactra 4 to 6 years prior to enrolment at an&#xD;
             age of 11 years or older OR Individuals who have not received any previous&#xD;
             meningococcal vaccine.&#xD;
&#xD;
          3. Individuals who have voluntarily given written informed consent after the nature of&#xD;
             the study has been explained according to local regulatory requirements, prior to&#xD;
             study entry. If the subject is under age 18 at the time of enrolment, the&#xD;
             parent(s)/legal guardian(s) of the subject should have voluntarily given written&#xD;
             informed consent.&#xD;
&#xD;
          4. Individuals who can comply with study procedures including follow-up.&#xD;
&#xD;
          5. Males Or Females of non-childbearing potential Or&#xD;
&#xD;
               -  Females of childbearing potential who are using an effective birth control method&#xD;
                  which they intend to use for at least 30 days after the study vaccination.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Each subject must not have:&#xD;
&#xD;
          1. History of any meningococcal vaccine administration other than the single vaccination&#xD;
             given 4 to 6 years before OR History of any meningococcal vaccine administration.&#xD;
&#xD;
          2. Current or previous, confirmed or suspected disease caused by N. meningitidis.&#xD;
&#xD;
          3. Household contact with and/or intimate exposure to an individual with any laboratory&#xD;
             confirmed N. meningitidis infection within 60 days prior to study vaccination.&#xD;
&#xD;
          4. Progressive, unstable or uncontrolled clinical conditions.&#xD;
&#xD;
          5. Hypersensitivity, including allergy, to any component of vaccines, medicinal products&#xD;
             or medical equipment whose use is foreseen in this study.&#xD;
&#xD;
          6. Clinical conditions representing a contraindication to intramuscular vaccination (IM)&#xD;
             and blood draws.&#xD;
&#xD;
          7. Abnormal function of the immune system resulting from:&#xD;
&#xD;
               1. Clinical conditions.&#xD;
&#xD;
               2. Systemic administration of corticosteroids for more than 14 consecutive days&#xD;
                  within 90 days prior to study vaccination.&#xD;
&#xD;
               3. Administration of antineoplastic and immunomodulating agents or radiotherapy&#xD;
                  within 90 days prior to study vaccination.&#xD;
&#xD;
          8. Received immunoglobulins or any blood products within 180 days prior to informed&#xD;
             consent.&#xD;
&#xD;
          9. Received systemic antibiotic treatment within 3 days prior to study vaccination or&#xD;
             blood draw.&#xD;
&#xD;
         10. Received an investigational or non-registered medicinal product within 30 days prior&#xD;
             to study vaccination.&#xD;
&#xD;
         11. Study personnel as an immediate family or household member.&#xD;
&#xD;
         12. Individuals who have received any other vaccines within 7 days or 14 days prior to&#xD;
             vaccination in this study or who are planning to receive any vaccine within 28 days&#xD;
             from the study vaccination.&#xD;
&#xD;
         13. Individuals who have experienced a moderate or severe acute infection and/or fever&#xD;
             defined as a temperature ≥38°C (100.4°F) within 3 days prior to study vaccination.&#xD;
&#xD;
         14. Any other clinical condition that, in the opinion of the investigator, might pose&#xD;
             additional risk to the subject due to participation in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>55 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>35211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35802</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Chandler</city>
        <state>Arizona</state>
        <zip>85224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Roseville</city>
        <state>California</state>
        <zip>95661</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95815</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95864</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>San Jose</city>
        <state>California</state>
        <zip>95119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Centennial</city>
        <state>Colorado</state>
        <zip>80112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Littleton</city>
        <state>Colorado</state>
        <zip>80128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Pinellas Park</city>
        <state>Florida</state>
        <zip>33781</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33409</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <zip>83712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67205-1138</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bardstown</city>
        <state>Kentucky</state>
        <zip>40004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68114</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>Omaha</city>
        <state>Nebraska</state>
        <zip>68144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Binghamton</city>
        <state>New York</state>
        <zip>13901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</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>Charleston</city>
        <state>South Carolina</state>
        <zip>29407</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>Plano</city>
        <state>Texas</state>
        <zip>75024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>San Angelo</city>
        <state>Texas</state>
        <zip>76904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tomball</city>
        <state>Texas</state>
        <zip>77375</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Draper</city>
        <state>Utah</state>
        <zip>84020</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>South Jordan</city>
        <state>Utah</state>
        <zip>84095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ponce</city>
        <zip>00716</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Puerto Rico</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217381&amp;amp;parentIdentifier=205352&amp;amp;attachmentIdentifier=4b9c0f0f-df12-453e-bed2-1e14b1b278a1&amp;amp;fileName=gsk-205352-clinical-study-report-redact.pdf&amp;amp;versionIdentifier=</url>
    <description>Full CSR posting on GSK</description>
  </link>
  <reference>
    <citation>Tipton M, Daly W, Senders S, Block SL, Lattanzi M, Mzolo T, Barbi S, Pellegrini M, Keshavan P. MenACWY-CRM conjugate vaccine booster dose given 4-6 years after priming: Results from a phase IIIb, multicenter, open label study in adolescents and adults. Vaccine. 2019 Sep 30;37(42):6171-6179. doi: 10.1016/j.vaccine.2019.08.065. Epub 2019 Sep 5.</citation>
    <PMID>31495595</PMID>
  </reference>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <results_first_submitted>July 4, 2018</results_first_submitted>
  <results_first_submitted_qc>August 2, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">August 3, 2018</results_first_posted>
  <last_update_submitted>November 14, 2019</last_update_submitted>
  <last_update_submitted_qc>November 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Meningococcal disease</keyword>
  <keyword>Booster vaccination</keyword>
  <keyword>Meningitis</keyword>
  <keyword>Antibody persistence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Meningococcal Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>IPD is available via the Clinical Study Data Request site (click on the link provided below)</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>IPD is available via the Clinical Study Data Request site (click on the link provided below)</ipd_time_frame>
    <ipd_access_criteria>Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.</ipd_access_criteria>
    <ipd_url>https://clinicalstudydatarequest.com/Posting.aspx?ID=20103</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 24, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/54/NCT02986854/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 19, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/54/NCT02986854/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were recruited from 1 center in Puerto Rico and 37 centers in Unites States.</recruitment_details>
      <pre_assignment_details>704 subjects were enrolled in this study. Out of the 704 enrolled, 701 received the study vaccine</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Menveo-Menveo Group</title>
          <description>Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.</description>
        </group>
        <group group_id="P2">
          <title>Menactra-Menveo Group</title>
          <description>Healthy subjects,15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.</description>
        </group>
        <group group_id="P3">
          <title>Naive Group</title>
          <description>Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="301"/>
                <participants group_id="P2" count="300"/>
                <participants group_id="P3" count="100"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="298"/>
                <participants group_id="P2" count="288"/>
                <participants group_id="P3" count="97"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Menveo-Menveo Group</title>
          <description>Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.</description>
        </group>
        <group group_id="B2">
          <title>Menactra-Menveo Group</title>
          <description>Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.</description>
        </group>
        <group group_id="B3">
          <title>Naive Group</title>
          <description>Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1.</description>
        </group>
        <group group_id="B4">
          <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="301"/>
            <count group_id="B2" value="300"/>
            <count group_id="B3" value="100"/>
            <count group_id="B4" value="701"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17.1" spread="3.66"/>
                    <measurement group_id="B2" value="17.9" spread="4.54"/>
                    <measurement group_id="B3" value="38.8" spread="10.47"/>
                    <measurement group_id="B4" value="20.5" spread="9.25"/>
                  </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="144"/>
                    <measurement group_id="B2" value="156"/>
                    <measurement group_id="B3" value="68"/>
                    <measurement group_id="B4" value="368"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="157"/>
                    <measurement group_id="B2" value="144"/>
                    <measurement group_id="B3" value="32"/>
                    <measurement group_id="B4" value="333"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>American Indian or Alaska Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native Hawaiian or other Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unspecified</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="251"/>
                    <measurement group_id="B2" value="233"/>
                    <measurement group_id="B3" value="79"/>
                    <measurement group_id="B4" value="563"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y.</title>
        <description>Seroresponse was defined as follows:for subjects with pre-vaccination hSBA titers&lt; 4,postvaccination hSBA titers≥16;for subjects with pre-vaccination hSBA titers≥4,post vaccination hSBA titers of atleast 4 times the pre-vaccination titers.Criteria to demonstrate primary objectives:Immune response sufficiency was tested sequentially;first in the group of subjects who received primary vaccination with Menveo &amp;,if met,also in group of subjects who received primary vaccination with Menactra.Immune response is considered sufficient if lower limit of the 1-sided 97.5% CI for percentage of subjects with hSBA seroresponse against serogroups A, C, W &amp; Y is greater than 75%.Study is considered successful if immune response sufficiency is demonstrated atleast in group of subjects who received primary vaccination with Menveo.This outcome measure was assessed only on subjects from Menveo-Menveo &amp; Menactra-Menveo groups.Data from pooled and Naive groups are presented as part of secondary objectives</description>
        <time_frame>At Day 29</time_frame>
        <population>Analysis was performed on the per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis who received the study vaccination &amp; provided evaluable serum samples at Day 29 with results available for atleast one serogroup</population>
        <group_list>
          <group group_id="O1">
            <title>Menveo-Menveo Group</title>
            <description>Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Menactra-Menveo Group</title>
            <description>Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Pooled Group (Menveo-Menveo and Menactra-Menveo)</title>
            <description>Pooled subjects from both Menveo-Menveo and Menactra-Menveo Groups</description>
          </group>
          <group group_id="O4">
            <title>Naive Group</title>
            <description>Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y.</title>
          <description>Seroresponse was defined as follows:for subjects with pre-vaccination hSBA titers&lt; 4,postvaccination hSBA titers≥16;for subjects with pre-vaccination hSBA titers≥4,post vaccination hSBA titers of atleast 4 times the pre-vaccination titers.Criteria to demonstrate primary objectives:Immune response sufficiency was tested sequentially;first in the group of subjects who received primary vaccination with Menveo &amp;,if met,also in group of subjects who received primary vaccination with Menactra.Immune response is considered sufficient if lower limit of the 1-sided 97.5% CI for percentage of subjects with hSBA seroresponse against serogroups A, C, W &amp; Y is greater than 75%.Study is considered successful if immune response sufficiency is demonstrated atleast in group of subjects who received primary vaccination with Menveo.This outcome measure was assessed only on subjects from Menveo-Menveo &amp; Menactra-Menveo groups.Data from pooled and Naive groups are presented as part of secondary objectives</description>
          <population>Analysis was performed on the per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis who received the study vaccination &amp; provided evaluable serum samples at Day 29 with results available for atleast one serogroup</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="290"/>
                <count group_id="O2" value="282"/>
                <count group_id="O3" value="571"/>
                <count group_id="O4" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>hSBA-Men A, Pre &lt; 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="246"/>
                    <count group_id="O2" value="234"/>
                    <count group_id="O3" value="480"/>
                    <count group_id="O4" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.97" lower_limit="95.32" upper_limit="99.34"/>
                    <measurement group_id="O2" value="97.01" lower_limit="93.93" upper_limit="98.79"/>
                    <measurement group_id="O3" value="97.50" lower_limit="95.67" upper_limit="98.70"/>
                    <measurement group_id="O4" value="64.71" lower_limit="53.59" upper_limit="74.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men A, Pre ≥ 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="48"/>
                    <count group_id="O3" value="91"/>
                    <count group_id="O4" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.37" lower_limit="74.92" upper_limit="96.11"/>
                    <measurement group_id="O2" value="93.75" lower_limit="82.8" upper_limit="98.69"/>
                    <measurement group_id="O3" value="91.21" lower_limit="83.41" upper_limit="96.13"/>
                    <measurement group_id="O4" value="75.00" lower_limit="34.91" upper_limit="96.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men A, Total seroresponse</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="289"/>
                    <count group_id="O2" value="282"/>
                    <count group_id="O3" value="571"/>
                    <count group_id="O4" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.54" lower_limit="93.73" upper_limit="98.33"/>
                    <measurement group_id="O2" value="96.45" lower_limit="93.58" upper_limit="98.29"/>
                    <measurement group_id="O3" value="96.50" lower_limit="94.64" upper_limit="97.85"/>
                    <measurement group_id="O4" value="65.59" lower_limit="55.02" upper_limit="75.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men C, Pre &lt; 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="103"/>
                    <count group_id="O3" value="188"/>
                    <count group_id="O4" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="95.75" upper_limit="100"/>
                    <measurement group_id="O2" value="100" lower_limit="96.48" upper_limit="100"/>
                    <measurement group_id="O3" value="100" lower_limit="98.06" upper_limit="100"/>
                    <measurement group_id="O4" value="55.81" lower_limit="39.88" upper_limit="70.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men C, Pre ≥ 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="203"/>
                    <count group_id="O2" value="177"/>
                    <count group_id="O3" value="380"/>
                    <count group_id="O4" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.6" lower_limit="89.3" upper_limit="96.55"/>
                    <measurement group_id="O2" value="93.79" lower_limit="89.15" upper_limit="96.86"/>
                    <measurement group_id="O3" value="93.68" lower_limit="90.75" upper_limit="95.91"/>
                    <measurement group_id="O4" value="58.00" lower_limit="43.21" upper_limit="71.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men C, Total seroresponse</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="288"/>
                    <count group_id="O2" value="280"/>
                    <count group_id="O3" value="568"/>
                    <count group_id="O4" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.49" lower_limit="92.4" upper_limit="97.57"/>
                    <measurement group_id="O2" value="96.07" lower_limit="93.08" upper_limit="98.02"/>
                    <measurement group_id="O3" value="95.77" lower_limit="93.78" upper_limit="97.27"/>
                    <measurement group_id="O4" value="56.99" lower_limit="46.31" upper_limit="67.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men W, Pre &lt; 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="58"/>
                    <count group_id="O3" value="110"/>
                    <count group_id="O4" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="93.15" upper_limit="100"/>
                    <measurement group_id="O2" value="100" lower_limit="93.84" upper_limit="100"/>
                    <measurement group_id="O3" value="100" lower_limit="96.70" upper_limit="100"/>
                    <measurement group_id="O4" value="54.55" lower_limit="36.35" upper_limit="71.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men W, Pre ≥ 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="237"/>
                    <count group_id="O2" value="223"/>
                    <count group_id="O3" value="460"/>
                    <count group_id="O4" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.94" lower_limit="91.32" upper_limit="97.36"/>
                    <measurement group_id="O2" value="91.48" lower_limit="87.01" upper_limit="94.79"/>
                    <measurement group_id="O3" value="93.26" lower_limit="90.57" upper_limit="95.38"/>
                    <measurement group_id="O4" value="25.42" lower_limit="14.98" upper_limit="38.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men W, Total seroresponse</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="289"/>
                    <count group_id="O2" value="281"/>
                    <count group_id="O3" value="570"/>
                    <count group_id="O4" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.85" lower_limit="92.86" upper_limit="97.84"/>
                    <measurement group_id="O2" value="93.24" lower_limit="89.64" upper_limit="95.88"/>
                    <measurement group_id="O3" value="94.56" lower_limit="92.37" upper_limit="96.28"/>
                    <measurement group_id="O4" value="35.87" lower_limit="26.13" upper_limit="46.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men Y, Pre &lt; 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="115"/>
                    <count group_id="O2" value="123"/>
                    <count group_id="O3" value="238"/>
                    <count group_id="O4" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="96.84" upper_limit="100"/>
                    <measurement group_id="O2" value="97.56" lower_limit="93.04" upper_limit="99.49"/>
                    <measurement group_id="O3" value="98.74" lower_limit="96.36" upper_limit="99.74"/>
                    <measurement group_id="O4" value="55.56" lower_limit="41.40" upper_limit="69.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men Y, Pre ≥ 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="172"/>
                    <count group_id="O2" value="157"/>
                    <count group_id="O3" value="329"/>
                    <count group_id="O4" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.77" lower_limit="90.3" upper_limit="97.58"/>
                    <measurement group_id="O2" value="91.72" lower_limit="86.26" upper_limit="95.52"/>
                    <measurement group_id="O3" value="93.31" lower_limit="90.05" upper_limit="95.76"/>
                    <measurement group_id="O4" value="46.15" lower_limit="30.09" upper_limit="62.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men Y, Total seroresponse</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="287"/>
                    <count group_id="O2" value="280"/>
                    <count group_id="O3" value="567"/>
                    <count group_id="O4" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.86" lower_limit="94.13" upper_limit="98.56"/>
                    <measurement group_id="O2" value="94.29" lower_limit="90.89" upper_limit="96.7"/>
                    <measurement group_id="O3" value="95.59" lower_limit="93.56" upper_limit="97.13"/>
                    <measurement group_id="O4" value="51.61" lower_limit="41.01" upper_limit="62.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup A-day 29-Total seroresponse (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Difference in percentages</param_type>
            <param_value>30.95</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>21.76</ci_lower_limit>
            <ci_upper_limit>41.25</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup A-day 29-Total seroresponse (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Difference in percentages</param_type>
            <param_value>30.86</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>21.66</ci_lower_limit>
            <ci_upper_limit>41.17</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup A-day 29-Total seroresponse (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Difference in percentages</param_type>
            <param_value>30.91</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>21.89</ci_lower_limit>
            <ci_upper_limit>41.12</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup A- DAY 29 : Total seroresponse (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method.</non_inferiority_desc>
            <param_type>Difference in percentages</param_type>
            <param_value>0.09</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.15</ci_lower_limit>
            <ci_upper_limit>3.36</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup C-day 29-Total seroresponse (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Difference in percentages</param_type>
            <param_value>38.50</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>28.54</ci_lower_limit>
            <ci_upper_limit>48.90</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup C-day 29-Total seroresponse (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Difference in percentages</param_type>
            <param_value>39.08</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>29.16</ci_lower_limit>
            <ci_upper_limit>49.46</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup C-day 29-Total seroresponse (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Difference in percentages</param_type>
            <param_value>38.79</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>29.03</ci_lower_limit>
            <ci_upper_limit>49.06</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup C-DAY 29 : Total seroresponse (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Difference in percentages</param_type>
            <param_value>-0.59</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.12</ci_lower_limit>
            <ci_upper_limit>2.92</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup W-day 29-Total seroresponse (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Difference in percentages</param_type>
            <param_value>59.98</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>49.49</ci_lower_limit>
            <ci_upper_limit>69.32</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup W-day 29-Total seroresponse (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Difference in percentages</param_type>
            <param_value>57.37</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>46.71</ci_lower_limit>
            <ci_upper_limit>66.88</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup W-day 29-Total seroresponse (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Difference in percentages</param_type>
            <param_value>58.69</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>48.32</ci_lower_limit>
            <ci_upper_limit>67.94</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup W-DAY 29 : Total seroresponse (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Difference in percentages</param_type>
            <param_value>2.61</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>6.62</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y-day 29-Total seroresponse (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Difference in percentages</param_type>
            <param_value>45.25</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>35.11</ci_lower_limit>
            <ci_upper_limit>55.47</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y-day 29-Total seroresponse (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Difference in percentages</param_type>
            <param_value>42.67</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>32.34</ci_lower_limit>
            <ci_upper_limit>53.04</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y-day 29-Total seroresponse (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Difference in percentages</param_type>
            <param_value>43.98</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>33.92</ci_lower_limit>
            <ci_upper_limit>54.14</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y- DAY 29 : Total seroresponse (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Difference in percentages</param_type>
            <param_value>2.58</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.86</ci_lower_limit>
            <ci_upper_limit>6.3</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)</title>
        <description>An AE can be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom , or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product. An unsolicited adverse event is an adverse event that was not solicited using a subject diary and that was spontaneously communicated by a subject and/or parent(s)/legal guardian(s) who has signed the informed consent.</description>
        <time_frame>Within 30 minutes after vaccination</time_frame>
        <population>Analysis was performed on the unsolicited safety set which included all subjects who provided informed consent and demographic and/or baseline screening assessments, regardless of the subject's randomization and treatment status in the study, received a subject ID and reported any unsolicited adverse event.</population>
        <group_list>
          <group group_id="O1">
            <title>Menveo-Menveo Group</title>
            <description>Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Menactra-Menveo Group</title>
            <description>Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Pooled Group (Menveo-Menveo and Menactra-Menveo)</title>
            <description>Pooled subjects from both Menveo-Menveo and Menactra-Menveo Groups.</description>
          </group>
          <group group_id="O4">
            <title>Naive Group</title>
            <description>Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)</title>
          <description>An AE can be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom , or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product. An unsolicited adverse event is an adverse event that was not solicited using a subject diary and that was spontaneously communicated by a subject and/or parent(s)/legal guardian(s) who has signed the informed consent.</description>
          <population>Analysis was performed on the unsolicited safety set which included all subjects who provided informed consent and demographic and/or baseline screening assessments, regardless of the subject's randomization and treatment status in the study, received a subject ID and reported any unsolicited adverse event.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="301"/>
                <count group_id="O2" value="300"/>
                <count group_id="O3" value="601"/>
                <count group_id="O4" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting Solicited Local and Systemic AEs</title>
        <description>Assessed solicited local symptoms were injection site pain, erythema, induration. Assessed solicited systemic symptoms were fatigue, headache, myalgia, arthralgia, loss of appetite, nausea, chills and fever [defined and measured by a body temperature ≥37.5 degrees Celsius (ºC)]. Threshold for Erythema and Induration: Grade 0 (&lt;25 mm), Any (&gt;= 25 mm)</description>
        <time_frame>From Day 1 (6 hours) through Day 7 after vaccination</time_frame>
        <population>Analysis was performed on the solicited safety set which included all subjects who provided informed consent and demographic and/or baseline screening assessments, regardless of the subject's randomization and treatment status in the study, received a subject ID and reported any solicited adverse event.</population>
        <group_list>
          <group group_id="O1">
            <title>Menveo-Menveo Group</title>
            <description>Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Menactra-Menveo Group</title>
            <description>Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Pooled Group (Menveo-Menveo and Menactra-Menveo)</title>
            <description>Pooled subjects from both Menveo-Menveo and Menactra-Menveo Groups</description>
          </group>
          <group group_id="O4">
            <title>Naive Group</title>
            <description>Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Solicited Local and Systemic AEs</title>
          <description>Assessed solicited local symptoms were injection site pain, erythema, induration. Assessed solicited systemic symptoms were fatigue, headache, myalgia, arthralgia, loss of appetite, nausea, chills and fever [defined and measured by a body temperature ≥37.5 degrees Celsius (ºC)]. Threshold for Erythema and Induration: Grade 0 (&lt;25 mm), Any (&gt;= 25 mm)</description>
          <population>Analysis was performed on the solicited safety set which included all subjects who provided informed consent and demographic and/or baseline screening assessments, regardless of the subject's randomization and treatment status in the study, received a subject ID and reported any solicited adverse event.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="296"/>
                <count group_id="O2" value="296"/>
                <count group_id="O3" value="592"/>
                <count group_id="O4" value="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any Local symptom</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="296"/>
                    <count group_id="O2" value="296"/>
                    <count group_id="O3" value="592"/>
                    <count group_id="O4" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="119"/>
                    <measurement group_id="O2" value="97"/>
                    <measurement group_id="O3" value="216"/>
                    <measurement group_id="O4" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Systemic symptom</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="296"/>
                    <count group_id="O2" value="296"/>
                    <count group_id="O3" value="592"/>
                    <count group_id="O4" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="162"/>
                    <measurement group_id="O2" value="148"/>
                    <measurement group_id="O3" value="310"/>
                    <measurement group_id="O4" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Induration</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="286"/>
                    <count group_id="O2" value="286"/>
                    <count group_id="O3" value="572"/>
                    <count group_id="O4" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="24"/>
                    <measurement group_id="O4" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Erythema</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="286"/>
                    <count group_id="O2" value="287"/>
                    <count group_id="O3" value="573"/>
                    <count group_id="O4" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="20"/>
                    <measurement group_id="O4" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Pain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="292"/>
                    <count group_id="O2" value="296"/>
                    <count group_id="O3" value="588"/>
                    <count group_id="O4" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="114"/>
                    <measurement group_id="O2" value="96"/>
                    <measurement group_id="O3" value="210"/>
                    <measurement group_id="O4" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Nausea</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="294"/>
                    <count group_id="O2" value="294"/>
                    <count group_id="O3" value="588"/>
                    <count group_id="O4" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                    <measurement group_id="O2" value="44"/>
                    <measurement group_id="O3" value="92"/>
                    <measurement group_id="O4" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Fatigue</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="295"/>
                    <count group_id="O2" value="296"/>
                    <count group_id="O3" value="591"/>
                    <count group_id="O4" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="113"/>
                    <measurement group_id="O2" value="110"/>
                    <measurement group_id="O3" value="223"/>
                    <measurement group_id="O4" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Myalgia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="294"/>
                    <count group_id="O2" value="296"/>
                    <count group_id="O3" value="590"/>
                    <count group_id="O4" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55"/>
                    <measurement group_id="O2" value="54"/>
                    <measurement group_id="O3" value="109"/>
                    <measurement group_id="O4" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Arthralgia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="294"/>
                    <count group_id="O2" value="295"/>
                    <count group_id="O3" value="589"/>
                    <count group_id="O4" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44"/>
                    <measurement group_id="O2" value="38"/>
                    <measurement group_id="O3" value="82"/>
                    <measurement group_id="O4" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Headache</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="294"/>
                    <count group_id="O2" value="295"/>
                    <count group_id="O3" value="589"/>
                    <count group_id="O4" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="82"/>
                    <measurement group_id="O3" value="182"/>
                    <measurement group_id="O4" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any loss of apetite</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="294"/>
                    <count group_id="O2" value="296"/>
                    <count group_id="O3" value="590"/>
                    <count group_id="O4" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                    <measurement group_id="O2" value="46"/>
                    <measurement group_id="O3" value="83"/>
                    <measurement group_id="O4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any chills</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="294"/>
                    <count group_id="O2" value="295"/>
                    <count group_id="O3" value="589"/>
                    <count group_id="O4" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="35"/>
                    <measurement group_id="O3" value="69"/>
                    <measurement group_id="O4" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="296"/>
                    <count group_id="O2" value="296"/>
                    <count group_id="O3" value="592"/>
                    <count group_id="O4" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting Other Indicators of Reactogenicity</title>
        <description>Assessed indicators of reactogenicity were use of analgesics/antipyretics for prophylaxis, use of analgesics/antipyretics for treatment, body temperature (described as 0.5 °C increments from ≥ 36.0ºC)</description>
        <time_frame>From Day 1 (6 hours) through Day 7 after vaccination</time_frame>
        <population>Analysis was performed on the solicited safety set which included all subjects who provided informed consent and demographic and/or baseline screening assessments, regardless of the subject's randomization and treatment status in the study, received a subject ID and reported any solicited adverse event.</population>
        <group_list>
          <group group_id="O1">
            <title>Menveo-Menveo Group</title>
            <description>Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Menactra-Menveo Group</title>
            <description>Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Pooled Group (Menveo-Menveo and Menactra-Menveo)</title>
            <description>Pooled subjects from both Menveo-Menveo and Menactra-Menveo Groups</description>
          </group>
          <group group_id="O4">
            <title>Naive Group</title>
            <description>Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Other Indicators of Reactogenicity</title>
          <description>Assessed indicators of reactogenicity were use of analgesics/antipyretics for prophylaxis, use of analgesics/antipyretics for treatment, body temperature (described as 0.5 °C increments from ≥ 36.0ºC)</description>
          <population>Analysis was performed on the solicited safety set which included all subjects who provided informed consent and demographic and/or baseline screening assessments, regardless of the subject's randomization and treatment status in the study, received a subject ID and reported any solicited adverse event.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="296"/>
                <count group_id="O2" value="296"/>
                <count group_id="O3" value="592"/>
                <count group_id="O4" value="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Analgesics/antipyretics for prophylaxis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="294"/>
                    <count group_id="O2" value="295"/>
                    <count group_id="O3" value="589"/>
                    <count group_id="O4" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="28"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Analgesics/antipyretics for treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="293"/>
                    <count group_id="O2" value="295"/>
                    <count group_id="O3" value="588"/>
                    <count group_id="O4" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="24"/>
                    <measurement group_id="O3" value="42"/>
                    <measurement group_id="O4" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Body temperature (36.0 - 36.4 ºC)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="296"/>
                    <count group_id="O2" value="296"/>
                    <count group_id="O3" value="592"/>
                    <count group_id="O4" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68"/>
                    <measurement group_id="O2" value="57"/>
                    <measurement group_id="O3" value="125"/>
                    <measurement group_id="O4" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Body temperature (36.5 - 36.9 ºC)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="296"/>
                    <count group_id="O2" value="296"/>
                    <count group_id="O3" value="592"/>
                    <count group_id="O4" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="135"/>
                    <measurement group_id="O2" value="141"/>
                    <measurement group_id="O3" value="276"/>
                    <measurement group_id="O4" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Body temperature (37.0 - 37.4 ºC)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="296"/>
                    <count group_id="O2" value="296"/>
                    <count group_id="O3" value="592"/>
                    <count group_id="O4" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83"/>
                    <measurement group_id="O2" value="77"/>
                    <measurement group_id="O3" value="160"/>
                    <measurement group_id="O4" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Body temperature (37.5 - 37.9 ºC)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="296"/>
                    <count group_id="O2" value="296"/>
                    <count group_id="O3" value="592"/>
                    <count group_id="O4" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="15"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Body temperature (38.0 - 38.4 ºC)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="296"/>
                    <count group_id="O2" value="296"/>
                    <count group_id="O3" value="592"/>
                    <count group_id="O4" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Body temperature (38.5 - 38.9 ºC)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="296"/>
                    <count group_id="O2" value="296"/>
                    <count group_id="O3" value="592"/>
                    <count group_id="O4" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Body temperature (39.0 - 39.4 ºC)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="296"/>
                    <count group_id="O2" value="296"/>
                    <count group_id="O3" value="592"/>
                    <count group_id="O4" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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>Body temperature (39.5 - 39.9 ºC)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="296"/>
                    <count group_id="O2" value="296"/>
                    <count group_id="O3" value="592"/>
                    <count group_id="O4" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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>Body temperature (&gt;=40ºC)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="296"/>
                    <count group_id="O2" value="296"/>
                    <count group_id="O3" value="592"/>
                    <count group_id="O4" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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 Reporting All Unsolicited AEs</title>
        <description>An AE can be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom , or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product. An unsolicited adverse event was an adverse event that was not solicited using a subject diary and that was spontaneously communicated by a subject and/or parent(s)/legal guardian(s) who has signed the informed consent.</description>
        <time_frame>From Day 1 through Day 29 after vaccination</time_frame>
        <population>Analysis was performed on the unsolicited safety set which included all subjects who provided informed consent and demographic and/or baseline screening assessments, regardless of the subject's randomization and treatment status in the study, received a subject ID and reported any unsolicited adverse event.</population>
        <group_list>
          <group group_id="O1">
            <title>Menveo-Menveo Group</title>
            <description>Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Menactra-Menveo Group</title>
            <description>Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Pooled Group (Menveo-Menveo and Menactra-Menveo)</title>
            <description>Pooled subjects from both Menveo-Menveo and Menactra-Menveo Groups</description>
          </group>
          <group group_id="O4">
            <title>Naive Group</title>
            <description>Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting All Unsolicited AEs</title>
          <description>An AE can be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom , or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product. An unsolicited adverse event was an adverse event that was not solicited using a subject diary and that was spontaneously communicated by a subject and/or parent(s)/legal guardian(s) who has signed the informed consent.</description>
          <population>Analysis was performed on the unsolicited safety set which included all subjects who provided informed consent and demographic and/or baseline screening assessments, regardless of the subject's randomization and treatment status in the study, received a subject ID and reported any unsolicited adverse event.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="301"/>
                <count group_id="O2" value="300"/>
                <count group_id="O3" value="601"/>
                <count group_id="O4" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74"/>
                    <measurement group_id="O2" value="78"/>
                    <measurement group_id="O3" value="152"/>
                    <measurement group_id="O4" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting Medically-attended AEs (MAAEs), AEs Leading to Withdrawal and Serious AEs (SAEs)</title>
        <description>Medically attended AEs were defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider.&#xD;
SAE was defined as any untoward medical occurrence that at any dose resulted in: death, was life-threatening, required or prolonged hospitalization, persistent or significant disability/incapacity, congenital anomaly/or birth defect, an important and significant medical event that might not have been immediately life threatening or resulting in death or hospitalization but, based upon appropriate medical judgment, might jeopardized the subject or might required intervention to prevent one of the other outcomes listed.</description>
        <time_frame>From Day 1 through Day 181 (entire study period)</time_frame>
        <population>Analysis was performed on the unsolicited safety set which included all subjects who provided informed consent and demographic and/or baseline screening assessments, regardless of the subject's randomization and treatment status in the study, received a subject ID and reported any unsolicited adverse event.</population>
        <group_list>
          <group group_id="O1">
            <title>Menveo-Menveo Group</title>
            <description>Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Menactra-Menveo Group</title>
            <description>Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Pooled Group (Menveo-Menveo and Menactra-Menveo)</title>
            <description>Pooled subjects from both Menveo-Menveo and Menactra-Menveo Groups</description>
          </group>
          <group group_id="O4">
            <title>Naive Group</title>
            <description>Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Medically-attended AEs (MAAEs), AEs Leading to Withdrawal and Serious AEs (SAEs)</title>
          <description>Medically attended AEs were defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider.&#xD;
SAE was defined as any untoward medical occurrence that at any dose resulted in: death, was life-threatening, required or prolonged hospitalization, persistent or significant disability/incapacity, congenital anomaly/or birth defect, an important and significant medical event that might not have been immediately life threatening or resulting in death or hospitalization but, based upon appropriate medical judgment, might jeopardized the subject or might required intervention to prevent one of the other outcomes listed.</description>
          <population>Analysis was performed on the unsolicited safety set which included all subjects who provided informed consent and demographic and/or baseline screening assessments, regardless of the subject's randomization and treatment status in the study, received a subject ID and reported any unsolicited adverse event.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="301"/>
                <count group_id="O2" value="300"/>
                <count group_id="O3" value="601"/>
                <count group_id="O4" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any MAAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="102"/>
                    <measurement group_id="O2" value="79"/>
                    <measurement group_id="O3" value="181"/>
                    <measurement group_id="O4" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any AEs leading to 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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup A</title>
        <description>For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated.</description>
        <time_frame>At Day 1 (pre-vaccination), Day 4, Day 6 and Day 29</time_frame>
        <population>Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup</population>
        <group_list>
          <group group_id="O1">
            <title>Menveo-Menveo Group</title>
            <description>Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Menactra-Menveo Group</title>
            <description>Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Pooled Group (Menveo-Menveo and Menactra-Menveo)</title>
            <description>Pooled subjects from both Menveo-Menveo and Menactra-Menveo Groups</description>
          </group>
          <group group_id="O4">
            <title>Naive Group</title>
            <description>Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup A</title>
          <description>For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated.</description>
          <population>Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup</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="290"/>
                <count group_id="O2" value="282"/>
                <count group_id="O3" value="572"/>
                <count group_id="O4" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>hSBA-Men A ≥ 8, Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="289"/>
                    <count group_id="O2" value="282"/>
                    <count group_id="O3" value="571"/>
                    <count group_id="O4" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.46" lower_limit="8.88" upper_limit="16.83"/>
                    <measurement group_id="O2" value="14.89" lower_limit="10.95" upper_limit="19.59"/>
                    <measurement group_id="O3" value="13.66" lower_limit="10.95" upper_limit="16.75"/>
                    <measurement group_id="O4" value="4.3" lower_limit="1.18" upper_limit="10.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men A ≥ 8, Day 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="144"/>
                    <count group_id="O2" value="138"/>
                    <count group_id="O3" value="282"/>
                    <count group_id="O4" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.11" lower_limit="6.49" upper_limit="17.42"/>
                    <measurement group_id="O2" value="13.04" lower_limit="7.92" upper_limit="19.83"/>
                    <measurement group_id="O3" value="12.06" lower_limit="8.5" upper_limit="16.44"/>
                    <measurement group_id="O4" value="4.17" lower_limit="0.51" upper_limit="14.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men A ≥ 8, Day 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="146"/>
                    <count group_id="O2" value="140"/>
                    <count group_id="O3" value="286"/>
                    <count group_id="O4" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.42" lower_limit="44.99" upper_limit="61.71"/>
                    <measurement group_id="O2" value="47.14" lower_limit="38.66" upper_limit="55.75"/>
                    <measurement group_id="O3" value="50.35" lower_limit="44.4" upper_limit="56.29"/>
                    <measurement group_id="O4" value="9.09" lower_limit="2.53" upper_limit="21.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men A ≥ 8, Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="290"/>
                    <count group_id="O2" value="282"/>
                    <count group_id="O3" value="572"/>
                    <count group_id="O4" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.62" lower_limit="96.51" upper_limit="99.62"/>
                    <measurement group_id="O2" value="98.94" lower_limit="96.92" upper_limit="99.78"/>
                    <measurement group_id="O3" value="98.78" lower_limit="97.49" upper_limit="99.51"/>
                    <measurement group_id="O4" value="70.97" lower_limit="60.64" upper_limit="79.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>8.16</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.23</ci_lower_limit>
            <ci_upper_limit>13.41</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method.</non_inferiority_desc>
            <param_type>Between group differences in percentage</param_type>
            <param_value>10.59</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.54</ci_lower_limit>
            <ci_upper_limit>16.14</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 1- (Pooled Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method.</non_inferiority_desc>
            <param_type>Between group differences in percentage</param_type>
            <param_value>9.36</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.72</ci_lower_limit>
            <ci_upper_limit>13.58</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method.</non_inferiority_desc>
            <param_type>Between group differences in percentage</param_type>
            <param_value>-2.44</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.17</ci_lower_limit>
            <ci_upper_limit>3.24</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>6.94</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.57</ci_lower_limit>
            <ci_upper_limit>14.15</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>8.88</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.77</ci_lower_limit>
            <ci_upper_limit>16.52</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>7.89</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.34</ci_lower_limit>
            <ci_upper_limit>13.48</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>-1.93</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.84</ci_lower_limit>
            <ci_upper_limit>5.82</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>44.33</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>30.25</ci_lower_limit>
            <ci_upper_limit>54.60</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>38.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>23.93</ci_lower_limit>
            <ci_upper_limit>48.58</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>41.26</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>28.15</ci_lower_limit>
            <ci_upper_limit>49.72</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>6.28</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.31</ci_lower_limit>
            <ci_upper_limit>17.71</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>27.65</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>19.25</ci_lower_limit>
            <ci_upper_limit>37.65</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>27.97</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>19.60</ci_lower_limit>
            <ci_upper_limit>37.95</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>27.81</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>19.50</ci_lower_limit>
            <ci_upper_limit>37.76</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>-0.32</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.56</ci_lower_limit>
            <ci_upper_limit>1.86</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup C</title>
        <description>For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated.</description>
        <time_frame>At day 1(pre-vaccination) , day 4, day 6 and day 29</time_frame>
        <population>Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup</population>
        <group_list>
          <group group_id="O1">
            <title>Menveo-Menveo Group</title>
            <description>Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Menactra-Menveo Group</title>
            <description>Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Pooled Group (Menveo-Menveo and Menactra-Menveo)</title>
            <description>Pooled subjects from both Menveo-Menveo and Menactra-Menveo Groups</description>
          </group>
          <group group_id="O4">
            <title>Naive Group</title>
            <description>Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup C</title>
          <description>For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated.</description>
          <population>Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup</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="290"/>
                <count group_id="O2" value="281"/>
                <count group_id="O3" value="571"/>
                <count group_id="O4" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>hSBA-Men C ≥ 8, Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="288"/>
                    <count group_id="O2" value="281"/>
                    <count group_id="O3" value="569"/>
                    <count group_id="O4" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.11" lower_limit="55.22" upper_limit="66.77"/>
                    <measurement group_id="O2" value="53.74" lower_limit="47.72" upper_limit="59.68"/>
                    <measurement group_id="O3" value="57.47" lower_limit="53.29" upper_limit="61.57"/>
                    <measurement group_id="O4" value="33.33" lower_limit="23.89" upper_limit="43.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men C ≥ 8, Day 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="144"/>
                    <count group_id="O2" value="138"/>
                    <count group_id="O3" value="282"/>
                    <count group_id="O4" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.83" lower_limit="62.68" upper_limit="78.1"/>
                    <measurement group_id="O2" value="60.14" lower_limit="51.47" upper_limit="68.38"/>
                    <measurement group_id="O3" value="65.6" lower_limit="59.74" upper_limit="71.13"/>
                    <measurement group_id="O4" value="43.75" lower_limit="29.48" upper_limit="58.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men C ≥ 8, Day 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="145"/>
                    <count group_id="O2" value="139"/>
                    <count group_id="O3" value="284"/>
                    <count group_id="O4" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.59" lower_limit="81.09" upper_limit="92.47"/>
                    <measurement group_id="O2" value="92.09" lower_limit="86.28" upper_limit="95.98"/>
                    <measurement group_id="O3" value="89.79" lower_limit="85.66" upper_limit="93.05"/>
                    <measurement group_id="O4" value="43.18" lower_limit="28.35" upper_limit="58.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men C ≥ 8, Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="290"/>
                    <count group_id="O2" value="281"/>
                    <count group_id="O3" value="571"/>
                    <count group_id="O4" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="98.74" upper_limit="100"/>
                    <measurement group_id="O2" value="99.64" lower_limit="98.03" upper_limit="99.99"/>
                    <measurement group_id="O3" value="99.82" lower_limit="99.03" upper_limit="100"/>
                    <measurement group_id="O4" value="87.1" lower_limit="78.55" upper_limit="93.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>27.78</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>16.23</ci_lower_limit>
            <ci_upper_limit>38.27</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>20.40</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>8.78</ci_lower_limit>
            <ci_upper_limit>31.03</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>24.14</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>13.28</ci_lower_limit>
            <ci_upper_limit>33.86</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>7.37</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>15.42</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>27.08</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>11.04</ci_lower_limit>
            <ci_upper_limit>42.14</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>16.39</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.04</ci_lower_limit>
            <ci_upper_limit>31.90</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>21.85</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>6.73</ci_lower_limit>
            <ci_upper_limit>36.11</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>10.69</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.42</ci_lower_limit>
            <ci_upper_limit>21.60</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>44.40</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>28.65</ci_lower_limit>
            <ci_upper_limit>58.93</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>48.90</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>33.45</ci_lower_limit>
            <ci_upper_limit>63.13</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>46.61</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>31.52</ci_lower_limit>
            <ci_upper_limit>60.59</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>-4.50</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-11.84</ci_lower_limit>
            <ci_upper_limit>2.69</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>12.90</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>7.53</ci_lower_limit>
            <ci_upper_limit>21.22</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>12.55</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>7.10</ci_lower_limit>
            <ci_upper_limit>20.89</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>12.73</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>7.34</ci_lower_limit>
            <ci_upper_limit>21.05</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>0.36</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.96</ci_lower_limit>
            <ci_upper_limit>1.99</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup W</title>
        <description>For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated.</description>
        <time_frame>At day 1(pre-vaccination), day 4, day 6 and day 29</time_frame>
        <population>Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup</population>
        <group_list>
          <group group_id="O1">
            <title>Menveo-Menveo Group</title>
            <description>Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Menactra-Menveo Group</title>
            <description>Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Pooled Group (Menveo-Menveo and Menactra-Menveo)</title>
            <description>Pooled subjects from both Menveo-Menveo and Menactra-Menveo Groups</description>
          </group>
          <group group_id="O4">
            <title>Naive Group</title>
            <description>Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup W</title>
          <description>For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated.</description>
          <population>Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup</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="290"/>
                <count group_id="O2" value="282"/>
                <count group_id="O3" value="571"/>
                <count group_id="O4" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>hSBA-Men W ≥ 8, Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="289"/>
                    <count group_id="O2" value="282"/>
                    <count group_id="O3" value="571"/>
                    <count group_id="O4" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.43" lower_limit="70.05" upper_limit="80.29"/>
                    <measurement group_id="O2" value="76.95" lower_limit="71.59" upper_limit="81.74"/>
                    <measurement group_id="O3" value="76.18" lower_limit="72.47" upper_limit="79.62"/>
                    <measurement group_id="O4" value="61.29" lower_limit="50.62" upper_limit="71.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men W ≥ 8, Day 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="144"/>
                    <count group_id="O2" value="138"/>
                    <count group_id="O3" value="282"/>
                    <count group_id="O4" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.94" lower_limit="74.67" upper_limit="87.85"/>
                    <measurement group_id="O2" value="82.61" lower_limit="75.24" upper_limit="88.53"/>
                    <measurement group_id="O3" value="82.27" lower_limit="77.3" upper_limit="86.54"/>
                    <measurement group_id="O4" value="62.5" lower_limit="47.35" upper_limit="76.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men W ≥ 8, Day 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="146"/>
                    <count group_id="O2" value="140"/>
                    <count group_id="O3" value="286"/>
                    <count group_id="O4" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.84" lower_limit="88.62" upper_limit="97.14"/>
                    <measurement group_id="O2" value="97.86" lower_limit="93.87" upper_limit="99.56"/>
                    <measurement group_id="O3" value="95.8" lower_limit="92.79" upper_limit="97.81"/>
                    <measurement group_id="O4" value="63.64" lower_limit="47.77" upper_limit="77.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men W ≥ 8, Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="290"/>
                    <count group_id="O2" value="281"/>
                    <count group_id="O3" value="571"/>
                    <count group_id="O4" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="98.74" upper_limit="100"/>
                    <measurement group_id="O2" value="100" lower_limit="98.7" upper_limit="100"/>
                    <measurement group_id="O3" value="100" lower_limit="99.36" upper_limit="100"/>
                    <measurement group_id="O4" value="84.78" lower_limit="75.79" upper_limit="91.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>14.14</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.46</ci_lower_limit>
            <ci_upper_limit>25.39</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>15.66</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>5.00</ci_lower_limit>
            <ci_upper_limit>26.89</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>14.89</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>4.91</ci_lower_limit>
            <ci_upper_limit>25.62</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>-1.52</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.51</ci_lower_limit>
            <ci_upper_limit>5.50</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>19.44</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>5.25</ci_lower_limit>
            <ci_upper_limit>34.83</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>20.11</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>5.88</ci_lower_limit>
            <ci_upper_limit>35.50</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>19.77</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>6.53</ci_lower_limit>
            <ci_upper_limit>34.58</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>-0.66</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.67</ci_lower_limit>
            <ci_upper_limit>8.40</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>30.20</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>16.78</ci_lower_limit>
            <ci_upper_limit>45.45</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>34.22</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>21.29</ci_lower_limit>
            <ci_upper_limit>49.20</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>32.17</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>19.30</ci_lower_limit>
            <ci_upper_limit>47.13</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>-4.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.45</ci_lower_limit>
            <ci_upper_limit>0.74</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>15.22</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>9.28</ci_lower_limit>
            <ci_upper_limit>23.95</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>15.22</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>9.28</ci_lower_limit>
            <ci_upper_limit>23.95</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>15.22</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>9.28</ci_lower_limit>
            <ci_upper_limit>23.94</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.31</ci_lower_limit>
            <ci_upper_limit>1.35</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup Y</title>
        <description>For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated.</description>
        <time_frame>At day 1(pre-vaccination), day 4, day 6 and day 29</time_frame>
        <population>Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup</population>
        <group_list>
          <group group_id="O1">
            <title>Menveo-Menveo Group</title>
            <description>Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Menactra-Menveo Group</title>
            <description>Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Pooled Group (Menveo-Menveo and Menactra-Menveo)</title>
            <description>Pooled subjects from both Menveo-Menveo and Menactra-Menveo Groups</description>
          </group>
          <group group_id="O4">
            <title>Naive Group</title>
            <description>Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup Y</title>
          <description>For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated.</description>
          <population>Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup</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="290"/>
                <count group_id="O2" value="281"/>
                <count group_id="O3" value="571"/>
                <count group_id="O4" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>hSBA-Men Y ≥ 8, Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="287"/>
                    <count group_id="O2" value="281"/>
                    <count group_id="O3" value="568"/>
                    <count group_id="O4" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.01" lower_limit="48.05" upper_limit="59.88"/>
                    <measurement group_id="O2" value="46.98" lower_limit="41.02" upper_limit="52.99"/>
                    <measurement group_id="O3" value="50.53" lower_limit="46.33" upper_limit="54.72"/>
                    <measurement group_id="O4" value="32.26" lower_limit="22.93" upper_limit="42.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men Y ≥ 8, Day 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="143"/>
                    <count group_id="O2" value="138"/>
                    <count group_id="O3" value="281"/>
                    <count group_id="O4" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.24" lower_limit="46.71" upper_limit="63.56"/>
                    <measurement group_id="O2" value="55.8" lower_limit="47.1" upper_limit="64.24"/>
                    <measurement group_id="O3" value="55.52" lower_limit="49.5" upper_limit="61.42"/>
                    <measurement group_id="O4" value="33.33" lower_limit="20.4" upper_limit="48.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men Y ≥ 8, Day 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="145"/>
                    <count group_id="O2" value="140"/>
                    <count group_id="O3" value="285"/>
                    <count group_id="O4" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.52" lower_limit="78.72" upper_limit="90.81"/>
                    <measurement group_id="O2" value="87.86" lower_limit="81.27" upper_limit="92.76"/>
                    <measurement group_id="O3" value="86.67" lower_limit="82.16" upper_limit="90.39"/>
                    <measurement group_id="O4" value="45.45" lower_limit="30.39" upper_limit="61.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men Y ≥ 8, Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="290"/>
                    <count group_id="O2" value="281"/>
                    <count group_id="O3" value="571"/>
                    <count group_id="O4" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="98.74" upper_limit="100"/>
                    <measurement group_id="O2" value="99.64" lower_limit="98.03" upper_limit="99.99"/>
                    <measurement group_id="O3" value="99.82" lower_limit="99.03" upper_limit="100"/>
                    <measurement group_id="O4" value="77.42" lower_limit="67.58" upper_limit="85.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>21.75</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>10.19</ci_lower_limit>
            <ci_upper_limit>32.25</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>14.72</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.15</ci_lower_limit>
            <ci_upper_limit>25.29</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>18.27</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>7.44</ci_lower_limit>
            <ci_upper_limit>27.92</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>7.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.20</ci_lower_limit>
            <ci_upper_limit>15.17</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>21.91</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>5.57</ci_lower_limit>
            <ci_upper_limit>36.37</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>22.46</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>6.05</ci_lower_limit>
            <ci_upper_limit>37.00</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>22.18</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>6.89</ci_lower_limit>
            <ci_upper_limit>35.38</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>-0.55</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.11</ci_lower_limit>
            <ci_upper_limit>11.03</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>40.06</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>24.26</ci_lower_limit>
            <ci_upper_limit>54.95</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>42.40</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>26.71</ci_lower_limit>
            <ci_upper_limit>57.17</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>41.21</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>26.12</ci_lower_limit>
            <ci_upper_limit>55.55</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>-2.34</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.41</ci_lower_limit>
            <ci_upper_limit>5.73</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>22.58</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>15.26</ci_lower_limit>
            <ci_upper_limit>32.08</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>22.22</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>14.86</ci_lower_limit>
            <ci_upper_limit>31.74</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>22.41</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>15.08</ci_lower_limit>
            <ci_upper_limit>31.90</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>0.36</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.96</ci_lower_limit>
            <ci_upper_limit>1.99</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup A</title>
        <description>For each study group and in the pooled group, percentages of subjects with hSBA titer ≥16 and associated two-sided 95%CIs were calculated.</description>
        <time_frame>At day 1(pre-vaccination), day 4, day 6 and day 29</time_frame>
        <population>Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup</population>
        <group_list>
          <group group_id="O1">
            <title>Menveo-Menveo Group</title>
            <description>Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Menactra-Menveo Group</title>
            <description>Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Pooled Group (Menveo-Menveo and Menactra-Menveo)</title>
            <description>Pooled subjects from both Menveo-Menveo and Menactra-Menveo Groups</description>
          </group>
          <group group_id="O4">
            <title>Naive Group</title>
            <description>Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup A</title>
          <description>For each study group and in the pooled group, percentages of subjects with hSBA titer ≥16 and associated two-sided 95%CIs were calculated.</description>
          <population>Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup</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="290"/>
                <count group_id="O2" value="282"/>
                <count group_id="O3" value="572"/>
                <count group_id="O4" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>hSBA-Men A ≥ 16, Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="289"/>
                    <count group_id="O2" value="282"/>
                    <count group_id="O3" value="571"/>
                    <count group_id="O4" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.3" lower_limit="5.39" upper_limit="12.1"/>
                    <measurement group_id="O2" value="9.57" lower_limit="6.4" upper_limit="13.62"/>
                    <measurement group_id="O3" value="8.93" lower_limit="6.72" upper_limit="11.58"/>
                    <measurement group_id="O4" value="1.08" lower_limit="0.03" upper_limit="5.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men A ≥ 16, Day 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="144"/>
                    <count group_id="O2" value="138"/>
                    <count group_id="O3" value="282"/>
                    <count group_id="O4" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.33" lower_limit="4.38" upper_limit="14.1"/>
                    <measurement group_id="O2" value="8.7" lower_limit="4.57" upper_limit="14.7"/>
                    <measurement group_id="O3" value="8.51" lower_limit="5.53" upper_limit="12.4"/>
                    <measurement group_id="O4" value="2.08" lower_limit="0.05" upper_limit="11.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men A ≥ 16, Day 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="146"/>
                    <count group_id="O2" value="140"/>
                    <count group_id="O3" value="286"/>
                    <count group_id="O4" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.89" lower_limit="37.62" upper_limit="54.33"/>
                    <measurement group_id="O2" value="41.43" lower_limit="33.17" upper_limit="50.05"/>
                    <measurement group_id="O3" value="43.71" lower_limit="37.87" upper_limit="49.67"/>
                    <measurement group_id="O4" value="4.55" lower_limit="0.56" upper_limit="15.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men A ≥ 16, Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="290"/>
                    <count group_id="O2" value="282"/>
                    <count group_id="O3" value="572"/>
                    <count group_id="O4" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.28" lower_limit="96.02" upper_limit="99.44"/>
                    <measurement group_id="O2" value="97.52" lower_limit="94.95" upper_limit="99"/>
                    <measurement group_id="O3" value="97.9" lower_limit="96.36" upper_limit="98.91"/>
                    <measurement group_id="O4" value="66.67" lower_limit="56.13" upper_limit="76.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>7.23</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.08</ci_lower_limit>
            <ci_upper_limit>11.23</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>8.50</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.28</ci_lower_limit>
            <ci_upper_limit>12.74</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>7.86</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.87</ci_lower_limit>
            <ci_upper_limit>10.78</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>-1.27</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.10</ci_lower_limit>
            <ci_upper_limit>3.49</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>6.25</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.04</ci_lower_limit>
            <ci_upper_limit>12.44</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>6.61</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.71</ci_lower_limit>
            <ci_upper_limit>13.01</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>6.43</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.66</ci_lower_limit>
            <ci_upper_limit>10.90</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>-0.36</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.27</ci_lower_limit>
            <ci_upper_limit>6.43</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>41.34</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>28.85</ci_lower_limit>
            <ci_upper_limit>50.63</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>36.88</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>24.39</ci_lower_limit>
            <ci_upper_limit>46.34</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>39.16</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>27.61</ci_lower_limit>
            <ci_upper_limit>46.33</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>4.46</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.04</ci_lower_limit>
            <ci_upper_limit>15.83</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>31.61</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>22.68</ci_lower_limit>
            <ci_upper_limit>41.79</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>30.85</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>21.85</ci_lower_limit>
            <ci_upper_limit>41.08</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>31.24</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>22.39</ci_lower_limit>
            <ci_upper_limit>41.38</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>0.76</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.81</ci_lower_limit>
            <ci_upper_limit>3.52</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup C</title>
        <description>Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup</description>
        <time_frame>At day 1(pre-vaccination) , day 4, day 6 and day 29</time_frame>
        <population>Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup</population>
        <group_list>
          <group group_id="O1">
            <title>Menveo-Menveo Group</title>
            <description>Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Menactra-Menveo Group</title>
            <description>Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Pooled Group (Menveo-Menveo and Menactra-Menveo)</title>
            <description>Pooled subjects from both Menveo-Menveo and Menactra-Menveo Groups</description>
          </group>
          <group group_id="O4">
            <title>Naive Group</title>
            <description>Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup C</title>
          <description>Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup</description>
          <population>Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup</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="290"/>
                <count group_id="O2" value="281"/>
                <count group_id="O3" value="571"/>
                <count group_id="O4" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>hSBA-Men C ≥ 16, Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="288"/>
                    <count group_id="O2" value="281"/>
                    <count group_id="O3" value="569"/>
                    <count group_id="O4" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.22" lower_limit="41.34" upper_limit="53.16"/>
                    <measurement group_id="O2" value="38.08" lower_limit="32.38" upper_limit="44.04"/>
                    <measurement group_id="O3" value="42.71" lower_limit="38.6" upper_limit="46.89"/>
                    <measurement group_id="O4" value="17.2" lower_limit="10.17" upper_limit="26.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men C ≥ 16, Day 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="144"/>
                    <count group_id="O2" value="138"/>
                    <count group_id="O3" value="282"/>
                    <count group_id="O4" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.17" lower_limit="45.67" upper_limit="62.49"/>
                    <measurement group_id="O2" value="44.93" lower_limit="36.46" upper_limit="53.62"/>
                    <measurement group_id="O3" value="49.65" lower_limit="43.66" upper_limit="55.64"/>
                    <measurement group_id="O4" value="29.17" lower_limit="16.95" upper_limit="44.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men C ≥ 16, Day 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="145"/>
                    <count group_id="O2" value="139"/>
                    <count group_id="O3" value="284"/>
                    <count group_id="O4" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.07" lower_limit="74.84" upper_limit="87.94"/>
                    <measurement group_id="O2" value="81.29" lower_limit="73.81" upper_limit="87.4"/>
                    <measurement group_id="O3" value="81.69" lower_limit="76.69" upper_limit="86.01"/>
                    <measurement group_id="O4" value="31.82" lower_limit="18.61" upper_limit="47.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men C ≥ 16, Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="290"/>
                    <count group_id="O2" value="281"/>
                    <count group_id="O3" value="571"/>
                    <count group_id="O4" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.66" lower_limit="98.09" upper_limit="99.99"/>
                    <measurement group_id="O2" value="99.64" lower_limit="98.03" upper_limit="99.99"/>
                    <measurement group_id="O3" value="99.65" lower_limit="98.74" upper_limit="99.96"/>
                    <measurement group_id="O4" value="69.89" lower_limit="59.5" upper_limit="78.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>30.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>19.55</ci_lower_limit>
            <ci_upper_limit>38.83</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>20.87</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>10.48</ci_lower_limit>
            <ci_upper_limit>29.69</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>25.50</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>15.79</ci_lower_limit>
            <ci_upper_limit>33.21</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>9.14</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.01</ci_lower_limit>
            <ci_upper_limit>17.16</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>25.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>8.82</ci_lower_limit>
            <ci_upper_limit>38.90</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>15.76</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.44</ci_lower_limit>
            <ci_upper_limit>29.86</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>20.48</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>5.32</ci_lower_limit>
            <ci_upper_limit>33.08</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>9.24</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.45</ci_lower_limit>
            <ci_upper_limit>20.68</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>50.25</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>34.09</ci_lower_limit>
            <ci_upper_limit>63.67</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>49.48</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>33.21</ci_lower_limit>
            <ci_upper_limit>63.01</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>49.87</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>34.42</ci_lower_limit>
            <ci_upper_limit>62.60</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>0.77</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.30</ci_lower_limit>
            <ci_upper_limit>9.92</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>29.76</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>21.34</ci_lower_limit>
            <ci_upper_limit>39.75</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>29.75</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>21.32</ci_lower_limit>
            <ci_upper_limit>39.74</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>29.76</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>21.35</ci_lower_limit>
            <ci_upper_limit>39.73</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>0.01</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.60</ci_lower_limit>
            <ci_upper_limit>1.67</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup W</title>
        <description>For each study group and in the pooled group, percentages of subjects with hSBA titer ≥16 and associated two-sided 95%CIs were calculated.</description>
        <time_frame>At day 1(pre-vaccination), day 4, day 6 and day 29</time_frame>
        <population>Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup</population>
        <group_list>
          <group group_id="O1">
            <title>Menveo-Menveo Group</title>
            <description>Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Menactra-Menveo Group</title>
            <description>Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Pooled Group (Menveo-Menveo and Menactra-Menveo)</title>
            <description>Pooled subjects from both Menveo-Menveo and Menactra-Menveo Groups</description>
          </group>
          <group group_id="O4">
            <title>Naive Group</title>
            <description>Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup W</title>
          <description>For each study group and in the pooled group, percentages of subjects with hSBA titer ≥16 and associated two-sided 95%CIs were calculated.</description>
          <population>Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup</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="290"/>
                <count group_id="O2" value="282"/>
                <count group_id="O3" value="571"/>
                <count group_id="O4" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>hSBA-Men W ≥ 16, Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="289"/>
                    <count group_id="O2" value="282"/>
                    <count group_id="O3" value="571"/>
                    <count group_id="O4" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.74" lower_limit="59.96" upper_limit="71.2"/>
                    <measurement group_id="O2" value="66.31" lower_limit="60.47" upper_limit="71.81"/>
                    <measurement group_id="O3" value="66.02" lower_limit="61.98" upper_limit="69.91"/>
                    <measurement group_id="O4" value="48.39" lower_limit="37.89" upper_limit="58.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men W ≥ 16, Day 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="144"/>
                    <count group_id="O2" value="138"/>
                    <count group_id="O3" value="282"/>
                    <count group_id="O4" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.75" lower_limit="60.5" upper_limit="76.21"/>
                    <measurement group_id="O2" value="76.81" lower_limit="68.87" upper_limit="83.57"/>
                    <measurement group_id="O3" value="72.7" lower_limit="67.1" upper_limit="77.81"/>
                    <measurement group_id="O4" value="54.17" lower_limit="39.17" upper_limit="68.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men W ≥ 16, Day 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="146"/>
                    <count group_id="O2" value="140"/>
                    <count group_id="O3" value="286"/>
                    <count group_id="O4" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.04" lower_limit="82.81" upper_limit="93.6"/>
                    <measurement group_id="O2" value="92.14" lower_limit="86.38" upper_limit="96.01"/>
                    <measurement group_id="O3" value="90.56" lower_limit="86.56" upper_limit="93.69"/>
                    <measurement group_id="O4" value="50" lower_limit="34.56" upper_limit="65.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men W ≥ 16, Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="290"/>
                    <count group_id="O2" value="281"/>
                    <count group_id="O3" value="571"/>
                    <count group_id="O4" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="98.74" upper_limit="100"/>
                    <measurement group_id="O2" value="100" lower_limit="98.7" upper_limit="100"/>
                    <measurement group_id="O3" value="100" lower_limit="99.36" upper_limit="100"/>
                    <measurement group_id="O4" value="80.43" lower_limit="70.85" upper_limit="87.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>17.36</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>5.85</ci_lower_limit>
            <ci_upper_limit>28.67</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>17.92</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>6.39</ci_lower_limit>
            <ci_upper_limit>29.25</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>17.64</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>6.85</ci_lower_limit>
            <ci_upper_limit>28.28</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>-0.57</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.32</ci_lower_limit>
            <ci_upper_limit>7.20</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>14.58</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>30.38</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>22.64</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>7.30</ci_lower_limit>
            <ci_upper_limit>38.16</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>18.53</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>4.14</ci_lower_limit>
            <ci_upper_limit>33.37</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>-8.06</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-18.34</ci_lower_limit>
            <ci_upper_limit>2.38</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>39.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>23.76</ci_lower_limit>
            <ci_upper_limit>54.07</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>42.14</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>27.08</ci_lower_limit>
            <ci_upper_limit>56.98</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>40.56</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>25.91</ci_lower_limit>
            <ci_upper_limit>55.15</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>-3.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.20</ci_lower_limit>
            <ci_upper_limit>3.89</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>19.57</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>12.74</ci_lower_limit>
            <ci_upper_limit>28.83</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>19.57</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>12.74</ci_lower_limit>
            <ci_upper_limit>28.83</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>19.57</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>12.75</ci_lower_limit>
            <ci_upper_limit>28.83</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.31</ci_lower_limit>
            <ci_upper_limit>1.35</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup Y</title>
        <description>For each study group and in the pooled group, percentages of subjects with hSBA titer ≥16 and associated two-sided 95%CIs were calculated.</description>
        <time_frame>At day 1(pre-vaccination) , day 4, day 6 and day 29</time_frame>
        <population>Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup</population>
        <group_list>
          <group group_id="O1">
            <title>Menveo-Menveo Group</title>
            <description>Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Menactra-Menveo Group</title>
            <description>Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Pooled Group (Menveo-Menveo and Menactra-Menveo)</title>
            <description>Pooled subjects from both Menveo-Menveo and Menactra-Menveo Groups</description>
          </group>
          <group group_id="O4">
            <title>Naive Group</title>
            <description>Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup Y</title>
          <description>For each study group and in the pooled group, percentages of subjects with hSBA titer ≥16 and associated two-sided 95%CIs were calculated.</description>
          <population>Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup</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="290"/>
                <count group_id="O2" value="281"/>
                <count group_id="O3" value="571"/>
                <count group_id="O4" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>hSBA-Men Y ≥ 16, Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="287"/>
                    <count group_id="O2" value="281"/>
                    <count group_id="O3" value="568"/>
                    <count group_id="O4" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.02" lower_limit="33.35" upper_limit="44.93"/>
                    <measurement group_id="O2" value="34.88" lower_limit="29.31" upper_limit="40.76"/>
                    <measurement group_id="O3" value="36.97" lower_limit="32.99" upper_limit="41.09"/>
                    <measurement group_id="O4" value="17.2" lower_limit="10.17" upper_limit="26.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men Y ≥ 16, Day 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="143"/>
                    <count group_id="O2" value="138"/>
                    <count group_id="O3" value="281"/>
                    <count group_id="O4" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.16" lower_limit="31.11" upper_limit="47.67"/>
                    <measurement group_id="O2" value="39.13" lower_limit="30.94" upper_limit="47.8"/>
                    <measurement group_id="O3" value="39.15" lower_limit="33.4" upper_limit="45.12"/>
                    <measurement group_id="O4" value="20.83" lower_limit="10.47" upper_limit="34.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men Y ≥ 16, Day 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="145"/>
                    <count group_id="O2" value="140"/>
                    <count group_id="O3" value="285"/>
                    <count group_id="O4" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.69" lower_limit="73.31" upper_limit="86.77"/>
                    <measurement group_id="O2" value="80" lower_limit="72.41" upper_limit="86.28"/>
                    <measurement group_id="O3" value="80.35" lower_limit="75.26" upper_limit="84.8"/>
                    <measurement group_id="O4" value="31.82" lower_limit="18.61" upper_limit="47.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men Y ≥ 16, Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="290"/>
                    <count group_id="O2" value="281"/>
                    <count group_id="O3" value="571"/>
                    <count group_id="O4" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="98.74" upper_limit="100"/>
                    <measurement group_id="O2" value="98.58" lower_limit="96.4" upper_limit="99.61"/>
                    <measurement group_id="O3" value="99.3" lower_limit="98.22" upper_limit="99.81"/>
                    <measurement group_id="O4" value="64.52" lower_limit="53.91" upper_limit="74.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>21.82</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>11.44</ci_lower_limit>
            <ci_upper_limit>30.60</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>17.67</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>7.34</ci_lower_limit>
            <ci_upper_limit>26.43</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>19.77</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>10.09</ci_lower_limit>
            <ci_upper_limit>27.43</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>4.15</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.80</ci_lower_limit>
            <ci_upper_limit>12.04</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>18.33</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.92</ci_lower_limit>
            <ci_upper_limit>30.99</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>18.30</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.83</ci_lower_limit>
            <ci_upper_limit>31.06</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>18.31</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.83</ci_lower_limit>
            <ci_upper_limit>29.39</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>0.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-11.35</ci_lower_limit>
            <ci_upper_limit>11.39</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>48.87</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>32.64</ci_lower_limit>
            <ci_upper_limit>62.38</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>48.18</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>31.87</ci_lower_limit>
            <ci_upper_limit>61.79</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>48.53</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>33.04</ci_lower_limit>
            <ci_upper_limit>61.31</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>0.69</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.60</ci_lower_limit>
            <ci_upper_limit>10.04</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>35.48</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>26.50</ci_lower_limit>
            <ci_upper_limit>45.62</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>34.06</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>24.94</ci_lower_limit>
            <ci_upper_limit>44.28</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>34.78</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>25.78</ci_lower_limit>
            <ci_upper_limit>44.93</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Between groups differences in percentage</param_type>
            <param_value>1.42</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.10</ci_lower_limit>
            <ci_upper_limit>3.60</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y</title>
        <description>Seroresponse is defined for this study as follows: For subjects with pre-vaccination titers &lt;4, postvaccination titers ≥ 16; for subjects with pre-vaccination titers ≥4, post vaccination titers at least 4 times the pre-vaccination titers.</description>
        <time_frame>At Day 4 and Day 6</time_frame>
        <population>Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup</population>
        <group_list>
          <group group_id="O1">
            <title>Menveo-Menveo Group</title>
            <description>Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Menactra-Menveo Group</title>
            <description>Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Pooled Group (Menveo-Menveo and Menactra-Menveo)</title>
            <description>Pooled subjects from both Menveo-Menveo and Menactra-Menveo Groups</description>
          </group>
          <group group_id="O4">
            <title>Naive Group</title>
            <description>Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y</title>
          <description>Seroresponse is defined for this study as follows: For subjects with pre-vaccination titers &lt;4, postvaccination titers ≥ 16; for subjects with pre-vaccination titers ≥4, post vaccination titers at least 4 times the pre-vaccination titers.</description>
          <population>Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup</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="289"/>
                <count group_id="O2" value="282"/>
                <count group_id="O3" value="571"/>
                <count group_id="O4" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>hSBA-Men A, Pre &lt; 4, Day 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="123"/>
                    <count group_id="O2" value="117"/>
                    <count group_id="O3" value="240"/>
                    <count group_id="O4" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.81" lower_limit="0.02" upper_limit="4.45"/>
                    <measurement group_id="O2" value="2.56" lower_limit="0.53" upper_limit="7.31"/>
                    <measurement group_id="O3" value="1.67" lower_limit="0.46" upper_limit="4.21"/>
                    <measurement group_id="O4" value="0" lower_limit="0" upper_limit="7.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men A, Pre ≥ 4, Day 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="42"/>
                    <count group_id="O4" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.76" lower_limit="0.12" upper_limit="23.82"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="16.11"/>
                    <measurement group_id="O3" value="2.38" lower_limit="0.06" upper_limit="12.57"/>
                    <measurement group_id="O4" value="0" lower_limit="0" upper_limit="70.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men A, Total seroresponse, Day 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="144"/>
                    <count group_id="O2" value="138"/>
                    <count group_id="O3" value="282"/>
                    <count group_id="O4" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.39" lower_limit="0.17" upper_limit="4.93"/>
                    <measurement group_id="O2" value="2.17" lower_limit="0.45" upper_limit="6.22"/>
                    <measurement group_id="O3" value="1.77" lower_limit="0.58" upper_limit="4.09"/>
                    <measurement group_id="O4" value="0" lower_limit="0" upper_limit="7.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men A, Pre &lt; 4, Day 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="123"/>
                    <count group_id="O2" value="113"/>
                    <count group_id="O3" value="236"/>
                    <count group_id="O4" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.84" lower_limit="31.12" upper_limit="49.05"/>
                    <measurement group_id="O2" value="33.63" lower_limit="25.01" upper_limit="43.12"/>
                    <measurement group_id="O3" value="36.86" lower_limit="30.7" upper_limit="43.37"/>
                    <measurement group_id="O4" value="2.56" lower_limit="0.06" upper_limit="13.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men A, Pre ≥ 4, Day 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="27"/>
                    <count group_id="O3" value="49"/>
                    <count group_id="O4" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.36" lower_limit="17.2" upper_limit="59.34"/>
                    <measurement group_id="O2" value="22.22" lower_limit="8.62" upper_limit="42.26"/>
                    <measurement group_id="O3" value="28.57" lower_limit="16.58" upper_limit="43.26"/>
                    <measurement group_id="O4" value="20" lower_limit="0.51" upper_limit="71.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men A, Total seroresponse, Day 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="145"/>
                    <count group_id="O2" value="140"/>
                    <count group_id="O3" value="285"/>
                    <count group_id="O4" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.31" lower_limit="31.31" upper_limit="47.76"/>
                    <measurement group_id="O2" value="31.43" lower_limit="23.85" upper_limit="39.81"/>
                    <measurement group_id="O3" value="35.44" lower_limit="29.89" upper_limit="41.3"/>
                    <measurement group_id="O4" value="4.55" lower_limit="0.56" upper_limit="15.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men C, Pre &lt; 4, Day 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="87"/>
                    <count group_id="O4" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="9.74"/>
                    <measurement group_id="O2" value="9.8" lower_limit="3.26" upper_limit="21.41"/>
                    <measurement group_id="O3" value="5.75" lower_limit="1.89" upper_limit="12.9"/>
                    <measurement group_id="O4" value="5" lower_limit="0.13" upper_limit="24.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men C, Pre ≥ 4, Day 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="86"/>
                    <count group_id="O3" value="193"/>
                    <count group_id="O4" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.74" lower_limit="1.03" upper_limit="9.3"/>
                    <measurement group_id="O2" value="8.14" lower_limit="3.34" upper_limit="16.05"/>
                    <measurement group_id="O3" value="5.7" lower_limit="2.88" upper_limit="9.97"/>
                    <measurement group_id="O4" value="7.14" lower_limit="0.88" upper_limit="23.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men C, Total seroresponse, Day 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="143"/>
                    <count group_id="O2" value="137"/>
                    <count group_id="O3" value="280"/>
                    <count group_id="O4" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8" lower_limit="0.77" upper_limit="7.01"/>
                    <measurement group_id="O2" value="8.76" lower_limit="4.61" upper_limit="14.8"/>
                    <measurement group_id="O3" value="5.71" lower_limit="3.3" upper_limit="9.11"/>
                    <measurement group_id="O4" value="6.25" lower_limit="1.31" upper_limit="17.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men C, Pre &lt; 4, Day 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="100"/>
                    <count group_id="O4" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.31" lower_limit="50.36" upper_limit="78.33"/>
                    <measurement group_id="O2" value="64.71" lower_limit="50.07" upper_limit="77.57"/>
                    <measurement group_id="O3" value="65" lower_limit="54.82" upper_limit="74.27"/>
                    <measurement group_id="O4" value="13.04" lower_limit="2.78" upper_limit="33.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men C, Pre ≥ 4, Day 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="95"/>
                    <count group_id="O2" value="88"/>
                    <count group_id="O3" value="183"/>
                    <count group_id="O4" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.21" lower_limit="34.02" upper_limit="54.77"/>
                    <measurement group_id="O2" value="38.64" lower_limit="28.44" upper_limit="49.62"/>
                    <measurement group_id="O3" value="41.53" lower_limit="34.31" upper_limit="49.03"/>
                    <measurement group_id="O4" value="9.52" lower_limit="1.17" upper_limit="30.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men C, Total seroresponse, Day 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="144"/>
                    <count group_id="O2" value="139"/>
                    <count group_id="O3" value="283"/>
                    <count group_id="O4" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.39" lower_limit="42.92" upper_limit="59.8"/>
                    <measurement group_id="O2" value="48.2" lower_limit="39.65" upper_limit="56.83"/>
                    <measurement group_id="O3" value="49.82" lower_limit="43.85" upper_limit="55.8"/>
                    <measurement group_id="O4" value="11.36" lower_limit="3.79" upper_limit="24.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men W, Pre &lt; 4, Day 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="51"/>
                    <count group_id="O4" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.52" lower_limit="1.17" upper_limit="30.38"/>
                    <measurement group_id="O2" value="30" lower_limit="14.73" upper_limit="49.4"/>
                    <measurement group_id="O3" value="21.57" lower_limit="11.29" upper_limit="35.32"/>
                    <measurement group_id="O4" value="11.76" lower_limit="1.46" upper_limit="36.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men W, Pre ≥ 4, Day 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="123"/>
                    <count group_id="O2" value="108"/>
                    <count group_id="O3" value="231"/>
                    <count group_id="O4" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.63" lower_limit="0.2" upper_limit="5.75"/>
                    <measurement group_id="O2" value="4.63" lower_limit="1.52" upper_limit="10.47"/>
                    <measurement group_id="O3" value="3.03" lower_limit="1.23" upper_limit="6.14"/>
                    <measurement group_id="O4" value="3.23" lower_limit="0.08" upper_limit="16.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men W, Total seroresponse, Day 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="144"/>
                    <count group_id="O2" value="138"/>
                    <count group_id="O3" value="282"/>
                    <count group_id="O4" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.78" lower_limit="0.76" upper_limit="6.96"/>
                    <measurement group_id="O2" value="10.14" lower_limit="5.66" upper_limit="16.44"/>
                    <measurement group_id="O3" value="6.38" lower_limit="3.83" upper_limit="9.9"/>
                    <measurement group_id="O4" value="6.25" lower_limit="1.31" upper_limit="17.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men W, Pre &lt; 4, Day 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="31"/>
                    <count group_id="O2" value="28"/>
                    <count group_id="O3" value="59"/>
                    <count group_id="O4" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.52" lower_limit="45.37" upper_limit="80.77"/>
                    <measurement group_id="O2" value="75" lower_limit="55.13" upper_limit="89.31"/>
                    <measurement group_id="O3" value="69.49" lower_limit="56.13" upper_limit="80.81"/>
                    <measurement group_id="O4" value="25" lower_limit="7.27" upper_limit="52.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men W, Pre ≥ 4, Day 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="114"/>
                    <count group_id="O2" value="112"/>
                    <count group_id="O3" value="226"/>
                    <count group_id="O4" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.49" lower_limit="37.1" upper_limit="56.07"/>
                    <measurement group_id="O2" value="42.86" lower_limit="33.55" upper_limit="52.55"/>
                    <measurement group_id="O3" value="44.69" lower_limit="38.09" upper_limit="51.43"/>
                    <measurement group_id="O4" value="3.57" lower_limit="0.09" upper_limit="18.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men W, Total seroresponse, Day 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="145"/>
                    <count group_id="O2" value="140"/>
                    <count group_id="O3" value="285"/>
                    <count group_id="O4" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.34" lower_limit="41.93" upper_limit="58.75"/>
                    <measurement group_id="O2" value="49.29" lower_limit="40.74" upper_limit="57.86"/>
                    <measurement group_id="O3" value="49.82" lower_limit="43.87" upper_limit="55.78"/>
                    <measurement group_id="O4" value="11.36" lower_limit="3.79" upper_limit="24.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men Y, Pre &lt; 4, Day 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                    <count group_id="O2" value="60"/>
                    <count group_id="O3" value="122"/>
                    <count group_id="O4" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.06" lower_limit="2.67" upper_limit="17.83"/>
                    <measurement group_id="O2" value="6.67" lower_limit="1.85" upper_limit="16.2"/>
                    <measurement group_id="O3" value="7.38" lower_limit="3.43" upper_limit="13.54"/>
                    <measurement group_id="O4" value="0" lower_limit="0" upper_limit="12.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men Y, Pre ≥ 4, Day 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="157"/>
                    <count group_id="O4" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.5" lower_limit="2.8" upper_limit="15.61"/>
                    <measurement group_id="O2" value="2.6" lower_limit="0.32" upper_limit="9.07"/>
                    <measurement group_id="O3" value="5.1" lower_limit="2.23" upper_limit="9.79"/>
                    <measurement group_id="O4" value="0" lower_limit="0" upper_limit="16.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men Y, Total seroresponse, Day 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="142"/>
                    <count group_id="O2" value="137"/>
                    <count group_id="O3" value="279"/>
                    <count group_id="O4" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.75" lower_limit="3.93" upper_limit="13.44"/>
                    <measurement group_id="O2" value="4.38" lower_limit="1.62" upper_limit="9.29"/>
                    <measurement group_id="O3" value="6.09" lower_limit="3.59" upper_limit="9.58"/>
                    <measurement group_id="O4" value="0" lower_limit="0" upper_limit="7.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men Y, Pre &lt; 4, Day 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="62"/>
                    <count group_id="O3" value="114"/>
                    <count group_id="O4" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.46" lower_limit="48.96" upper_limit="76.38"/>
                    <measurement group_id="O2" value="75.81" lower_limit="63.26" upper_limit="85.78"/>
                    <measurement group_id="O3" value="70.18" lower_limit="60.89" upper_limit="78.38"/>
                    <measurement group_id="O4" value="11.11" lower_limit="2.35" upper_limit="29.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men Y, Pre ≥ 4, Day 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="78"/>
                    <count group_id="O3" value="169"/>
                    <count group_id="O4" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.66" lower_limit="30.48" upper_limit="51.47"/>
                    <measurement group_id="O2" value="42.31" lower_limit="31.19" upper_limit="54.02"/>
                    <measurement group_id="O3" value="41.42" lower_limit="33.91" upper_limit="49.24"/>
                    <measurement group_id="O4" value="5.88" lower_limit="0.15" upper_limit="28.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men Y, Total seroresponse, Day 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="143"/>
                    <count group_id="O2" value="140"/>
                    <count group_id="O3" value="283"/>
                    <count group_id="O4" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.95" lower_limit="40.51" upper_limit="57.44"/>
                    <measurement group_id="O2" value="57.14" lower_limit="48.51" upper_limit="65.47"/>
                    <measurement group_id="O3" value="53" lower_limit="47.01" upper_limit="58.94"/>
                    <measurement group_id="O4" value="9.09" lower_limit="2.53" upper_limit="21.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup A- Day 4- Total seroresponse (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Differences in percentage</param_type>
            <param_value>1.39</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.08</ci_lower_limit>
            <ci_upper_limit>4.94</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup A- Day 4-Total seroresponse - (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Differences in percentage</param_type>
            <param_value>2.17</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.32</ci_lower_limit>
            <ci_upper_limit>6.21</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup A- Day 4-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Differences in percentage</param_type>
            <param_value>1.77</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.68</ci_lower_limit>
            <ci_upper_limit>4.09</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup A- Day 4-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Differences in percentage</param_type>
            <param_value>-0.79</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.98</ci_lower_limit>
            <ci_upper_limit>3.01</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup A- Day 6-Total seroresponse- (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Differences in percentage</param_type>
            <param_value>34.76</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>22.38</ci_lower_limit>
            <ci_upper_limit>44.07</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup A- Day 6-Total seroresponse - (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Differences in percentage</param_type>
            <param_value>26.88</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>14.67</ci_lower_limit>
            <ci_upper_limit>36.13</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup A- Day 6-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Differences in percentage</param_type>
            <param_value>30.89</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>19.42</ci_lower_limit>
            <ci_upper_limit>37.97</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup A- Day 6-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Differences in percentage</param_type>
            <param_value>7.88</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.25</ci_lower_limit>
            <ci_upper_limit>18.81</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup C- Day 4-Total seroresponse- (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Differences in percentage</param_type>
            <param_value>-3.45</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-14.26</ci_lower_limit>
            <ci_upper_limit>2.35</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup C- Day 4-Total seroresponse - (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Differences in percentage</param_type>
            <param_value>2.51</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.70</ci_lower_limit>
            <ci_upper_limit>9.98</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup C- Day 4-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Differences in percentage</param_type>
            <param_value>-0.54</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-11.35</ci_lower_limit>
            <ci_upper_limit>4.90</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup C- Day 4-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Differences in percentage</param_type>
            <param_value>-5.96</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.25</ci_lower_limit>
            <ci_upper_limit>-0.57</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup C- Day 6-Total seroresponse- (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Differences in percentage</param_type>
            <param_value>40.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>25.37</ci_lower_limit>
            <ci_upper_limit>50.92</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup C- Day 6-Total seroresponse - (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Differences in percentage</param_type>
            <param_value>36.84</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>22.14</ci_lower_limit>
            <ci_upper_limit>47.90</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup C- Day 6-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Differences in percentage</param_type>
            <param_value>38.46</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>24.79</ci_lower_limit>
            <ci_upper_limit>47.57</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup C- Day 6-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Differences in percentage</param_type>
            <param_value>3.19</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.44</ci_lower_limit>
            <ci_upper_limit>14.73</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup W- Day 4-Total seroresponse- (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Differences in percentage</param_type>
            <param_value>-3.47</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-14.28</ci_lower_limit>
            <ci_upper_limit>2.31</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup W- Day 4-Total seroresponse - (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Differences in percentage</param_type>
            <param_value>3.89</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.40</ci_lower_limit>
            <ci_upper_limit>11.60</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup W- Day 4-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Differences in percentage</param_type>
            <param_value>0.13</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.70</ci_lower_limit>
            <ci_upper_limit>5.66</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup W- Day 4-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Differences in percentage</param_type>
            <param_value>-7.37</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.89</ci_lower_limit>
            <ci_upper_limit>-1.80</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup W- Day 6-Total seroresponse- (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Differences in percentage</param_type>
            <param_value>38.98</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>24.35</ci_lower_limit>
            <ci_upper_limit>49.88</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup W- Day 6-Total seroresponse - (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Differences in percentage</param_type>
            <param_value>37.92</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>23.23</ci_lower_limit>
            <ci_upper_limit>48.95</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup W- Day 6-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Differences in percentage</param_type>
            <param_value>38.46</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>24.80</ci_lower_limit>
            <ci_upper_limit>47.56</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup W- Day 6-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Differences in percentage</param_type>
            <param_value>1.06</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.51</ci_lower_limit>
            <ci_upper_limit>12.60</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y- Day 4-Total seroresponse- (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Differences in percentage</param_type>
            <param_value>7.75</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.15</ci_lower_limit>
            <ci_upper_limit>13.36</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y- Day 4-Total seroresponse - (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Differences in percentage</param_type>
            <param_value>4.38</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.15</ci_lower_limit>
            <ci_upper_limit>9.24</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y- Day 4-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Differences in percentage</param_type>
            <param_value>6.09</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.41</ci_lower_limit>
            <ci_upper_limit>9.55</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y- Day 4-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Differences in percentage</param_type>
            <param_value>3.37</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.48</ci_lower_limit>
            <ci_upper_limit>9.54</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y- Day 6-Total seroresponse- (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Differences in percentage</param_type>
            <param_value>39.86</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>25.76</ci_lower_limit>
            <ci_upper_limit>50.29</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y- Day 6-Total seroresponse - (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Differences in percentage</param_type>
            <param_value>48.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>33.89</ci_lower_limit>
            <ci_upper_limit>58.34</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y- Day 6-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Differences in percentage</param_type>
            <param_value>43.91</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>30.79</ci_lower_limit>
            <ci_upper_limit>52.37</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y- Day 6-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen &amp; Nurminen score method</non_inferiority_desc>
            <param_type>Differences in percentage</param_type>
            <param_value>-8.19</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-19.61</ci_lower_limit>
            <ci_upper_limit>3.45</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y.</title>
        <description>For each N. meningitidis serogroup A, C, W and Y, unadjusted GMTs were calculated, with their associated two-sided 95% Confidence Interval.</description>
        <time_frame>At Day 1 (pre-vaccination), Day 4, Day 6 and Day 29</time_frame>
        <population>Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup</population>
        <group_list>
          <group group_id="O1">
            <title>Menveo-Menveo Group</title>
            <description>Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Menactra-Menveo Group</title>
            <description>Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Pooled Group (Menveo-Menveo and Menactra-Menveo)</title>
            <description>Pooled subjects from both Menveo-Menveo and Menactra-Menveo Groups</description>
          </group>
          <group group_id="O4">
            <title>Naive Group</title>
            <description>Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y.</title>
          <description>For each N. meningitidis serogroup A, C, W and Y, unadjusted GMTs were calculated, with their associated two-sided 95% Confidence Interval.</description>
          <population>Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup</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="290"/>
                <count group_id="O2" value="282"/>
                <count group_id="O3" value="572"/>
                <count group_id="O4" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>hSBA-Men A, Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="289"/>
                    <count group_id="O2" value="282"/>
                    <count group_id="O3" value="571"/>
                    <count group_id="O4" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.81" lower_limit="2.54" upper_limit="3.11"/>
                    <measurement group_id="O2" value="2.95" lower_limit="2.67" upper_limit="3.27"/>
                    <measurement group_id="O3" value="2.88" lower_limit="2.68" upper_limit="3.09"/>
                    <measurement group_id="O4" value="2.27" lower_limit="1.9" upper_limit="2.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men A, Day 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="144"/>
                    <count group_id="O2" value="138"/>
                    <count group_id="O3" value="282"/>
                    <count group_id="O4" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.83" lower_limit="2.43" upper_limit="3.29"/>
                    <measurement group_id="O2" value="3" lower_limit="2.57" upper_limit="3.51"/>
                    <measurement group_id="O3" value="2.91" lower_limit="2.61" upper_limit="3.25"/>
                    <measurement group_id="O4" value="2.25" lower_limit="1.73" upper_limit="2.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men A, Day 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="146"/>
                    <count group_id="O2" value="140"/>
                    <count group_id="O3" value="286"/>
                    <count group_id="O4" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.87" lower_limit="9.63" upper_limit="17.19"/>
                    <measurement group_id="O2" value="10.17" lower_limit="7.57" upper_limit="13.66"/>
                    <measurement group_id="O3" value="11.47" lower_limit="9.32" upper_limit="14.1"/>
                    <measurement group_id="O4" value="2.48" lower_limit="1.46" upper_limit="4.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men A, Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="290"/>
                    <count group_id="O2" value="282"/>
                    <count group_id="O3" value="572"/>
                    <count group_id="O4" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="210.1" lower_limit="181.07" upper_limit="243.78"/>
                    <measurement group_id="O2" value="236.69" lower_limit="203.56" upper_limit="275.2"/>
                    <measurement group_id="O3" value="222.81" lower_limit="200.43" upper_limit="247.7"/>
                    <measurement group_id="O4" value="32.11" lower_limit="24.7" upper_limit="41.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men C, Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="288"/>
                    <count group_id="O2" value="281"/>
                    <count group_id="O3" value="569"/>
                    <count group_id="O4" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.11" lower_limit="13.28" upper_limit="19.54"/>
                    <measurement group_id="O2" value="10.72" lower_limit="8.82" upper_limit="13.03"/>
                    <measurement group_id="O3" value="13.17" lower_limit="11.48" upper_limit="15.12"/>
                    <measurement group_id="O4" value="5.06" lower_limit="3.6" upper_limit="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men C, Day 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="144"/>
                    <count group_id="O2" value="138"/>
                    <count group_id="O3" value="282"/>
                    <count group_id="O4" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.96" lower_limit="17.31" upper_limit="30.45"/>
                    <measurement group_id="O2" value="14.29" lower_limit="10.71" upper_limit="19.07"/>
                    <measurement group_id="O3" value="18.21" lower_limit="14.86" upper_limit="22.31"/>
                    <measurement group_id="O4" value="6.69" lower_limit="4.1" upper_limit="10.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men C, Day 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="145"/>
                    <count group_id="O2" value="139"/>
                    <count group_id="O3" value="284"/>
                    <count group_id="O4" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.27" lower_limit="68.91" upper_limit="123.56"/>
                    <measurement group_id="O2" value="90.06" lower_limit="66.84" upper_limit="121.35"/>
                    <measurement group_id="O3" value="91.18" lower_limit="74.04" upper_limit="112.3"/>
                    <measurement group_id="O4" value="6.71" lower_limit="3.95" upper_limit="11.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men C, Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="290"/>
                    <count group_id="O2" value="281"/>
                    <count group_id="O3" value="571"/>
                    <count group_id="O4" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1159.93" lower_limit="977.33" upper_limit="1376.63"/>
                    <measurement group_id="O2" value="1057.66" lower_limit="888.74" upper_limit="1258.68"/>
                    <measurement group_id="O3" value="1108.42" lower_limit="981.09" upper_limit="1252.27"/>
                    <measurement group_id="O4" value="59.7" lower_limit="44.12" upper_limit="80.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men W, Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="289"/>
                    <count group_id="O2" value="282"/>
                    <count group_id="O3" value="571"/>
                    <count group_id="O4" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.07" lower_limit="18.54" upper_limit="26.29"/>
                    <measurement group_id="O2" value="23.46" lower_limit="19.66" upper_limit="28"/>
                    <measurement group_id="O3" value="22.75" lower_limit="20.09" upper_limit="25.76"/>
                    <measurement group_id="O4" value="12.21" lower_limit="8.98" upper_limit="16.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men W, Day 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="144"/>
                    <count group_id="O2" value="138"/>
                    <count group_id="O3" value="282"/>
                    <count group_id="O4" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.9" lower_limit="20.13" upper_limit="33.32"/>
                    <measurement group_id="O2" value="33.87" lower_limit="26.18" upper_limit="43.82"/>
                    <measurement group_id="O3" value="29.53" lower_limit="24.66" upper_limit="35.37"/>
                    <measurement group_id="O4" value="13.8" lower_limit="8.92" upper_limit="21.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men W, Day 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="146"/>
                    <count group_id="O2" value="140"/>
                    <count group_id="O3" value="286"/>
                    <count group_id="O4" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="112.49" lower_limit="86.26" upper_limit="146.71"/>
                    <measurement group_id="O2" value="143.75" lower_limit="109.61" upper_limit="188.54"/>
                    <measurement group_id="O3" value="126.84" lower_limit="104.9" upper_limit="153.37"/>
                    <measurement group_id="O4" value="15.98" lower_limit="9.85" upper_limit="25.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men W, Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="290"/>
                    <count group_id="O2" value="281"/>
                    <count group_id="O3" value="571"/>
                    <count group_id="O4" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1394.65" lower_limit="1176.59" upper_limit="1653.11"/>
                    <measurement group_id="O2" value="1883.96" lower_limit="1585.12" upper_limit="2239.15"/>
                    <measurement group_id="O3" value="1617.11" lower_limit="1431.93" upper_limit="1826.23"/>
                    <measurement group_id="O4" value="55.31" lower_limit="40.9" upper_limit="74.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men Y, Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="287"/>
                    <count group_id="O2" value="281"/>
                    <count group_id="O3" value="568"/>
                    <count group_id="O4" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.24" lower_limit="7.81" upper_limit="10.94"/>
                    <measurement group_id="O2" value="8.22" lower_limit="6.93" upper_limit="9.75"/>
                    <measurement group_id="O3" value="8.72" lower_limit="7.74" upper_limit="9.83"/>
                    <measurement group_id="O4" value="4.56" lower_limit="3.39" upper_limit="6.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men Y, Day 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="143"/>
                    <count group_id="O2" value="138"/>
                    <count group_id="O3" value="281"/>
                    <count group_id="O4" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.87" lower_limit="8.26" upper_limit="14.32"/>
                    <measurement group_id="O2" value="12.12" lower_limit="9.16" upper_limit="16.04"/>
                    <measurement group_id="O3" value="11.47" lower_limit="9.43" upper_limit="13.95"/>
                    <measurement group_id="O4" value="4.63" lower_limit="2.88" upper_limit="7.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men Y, Day 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="145"/>
                    <count group_id="O2" value="140"/>
                    <count group_id="O3" value="285"/>
                    <count group_id="O4" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.3" lower_limit="47.73" upper_limit="83.95"/>
                    <measurement group_id="O2" value="61.56" lower_limit="46.18" upper_limit="82.05"/>
                    <measurement group_id="O3" value="62.44" lower_limit="51.06" upper_limit="76.34"/>
                    <measurement group_id="O4" value="6.44" lower_limit="3.86" upper_limit="10.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men Y, Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="290"/>
                    <count group_id="O2" value="281"/>
                    <count group_id="O3" value="571"/>
                    <count group_id="O4" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1066.66" lower_limit="900.67" upper_limit="1263.25"/>
                    <measurement group_id="O2" value="1007.62" lower_limit="848.53" upper_limit="1196.54"/>
                    <measurement group_id="O3" value="1037.19" lower_limit="919.46" upper_limit="1169.98"/>
                    <measurement group_id="O4" value="37.4" lower_limit="27.75" upper_limit="50.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup A-Vaccine comparison at day 4(Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified</non_inferiority_desc>
            <param_type>Between group GMT ratios</param_type>
            <param_value>1.26</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.93</ci_lower_limit>
            <ci_upper_limit>1.70</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup A-Vaccine comparison at day 4(Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified</non_inferiority_desc>
            <param_type>Between group GMT ratios</param_type>
            <param_value>1.34</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>1.82</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup A-Vaccine comparison at day 4(Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified</non_inferiority_desc>
            <param_type>Between group GMT ratios</param_type>
            <param_value>1.29</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.97</ci_lower_limit>
            <ci_upper_limit>1.72</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup A-Vaccine comparison at day 4 (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified</non_inferiority_desc>
            <param_type>Between group GMT ratios</param_type>
            <param_value>0.94</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.76</ci_lower_limit>
            <ci_upper_limit>1.17</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup A-Vaccine comparison at day 6 (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified</non_inferiority_desc>
            <param_type>Between group GMT ratios</param_type>
            <param_value>5.19</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.84</ci_lower_limit>
            <ci_upper_limit>9.47</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup A-Vaccine comparison at day 6 (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified</non_inferiority_desc>
            <param_type>Between group GMT ratios</param_type>
            <param_value>4.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.24</ci_lower_limit>
            <ci_upper_limit>7.50</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup A-Vaccine comparison at day 6 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified</non_inferiority_desc>
            <param_type>Between group GMT ratios</param_type>
            <param_value>4.62</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.62</ci_lower_limit>
            <ci_upper_limit>8.15</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup A-Vaccine comparison at day 6 (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified</non_inferiority_desc>
            <param_type>Between group GMT ratios</param_type>
            <param_value>1.27</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.84</ci_lower_limit>
            <ci_upper_limit>1.91</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup A-Vaccine comparison at day 29 (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified</non_inferiority_desc>
            <param_type>Between group GMT ratios</param_type>
            <param_value>6.54</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>4.84</ci_lower_limit>
            <ci_upper_limit>8.85</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup A-Vaccine comparison at day 29 (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified</non_inferiority_desc>
            <param_type>Between group GMT ratios</param_type>
            <param_value>7.37</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>5.44</ci_lower_limit>
            <ci_upper_limit>9.98</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup A-Vaccine comparison at day 29 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified</non_inferiority_desc>
            <param_type>Between group GMT ratios</param_type>
            <param_value>6.94</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>5.23</ci_lower_limit>
            <ci_upper_limit>9.21</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup A-Vaccine comparison at day 29 (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified</non_inferiority_desc>
            <param_type>Between group GMT ratios</param_type>
            <param_value>0.89</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.72</ci_lower_limit>
            <ci_upper_limit>1.10</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup C-Vaccine comparison at day 4 (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified</non_inferiority_desc>
            <param_type>between group GMT ratios</param_type>
            <param_value>3.43</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.95</ci_lower_limit>
            <ci_upper_limit>6.04</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup C-Vaccine comparison at day 4 (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified</non_inferiority_desc>
            <param_type>Between group GMT ratios</param_type>
            <param_value>2.14</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.21</ci_lower_limit>
            <ci_upper_limit>3.77</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup C-Vaccine comparison at day 4 - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified</non_inferiority_desc>
            <param_type>Between group GMT ratios</param_type>
            <param_value>2.72</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.60</ci_lower_limit>
            <ci_upper_limit>4.64</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup C-Vaccine comparison at day 4 (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified</non_inferiority_desc>
            <param_type>Between group GMT ratios</param_type>
            <param_value>1.61</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.07</ci_lower_limit>
            <ci_upper_limit>2.40</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup C-Vaccine comparison at day 6 (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified</non_inferiority_desc>
            <param_type>Between group GMT ratios</param_type>
            <param_value>13.75</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>7.51</ci_lower_limit>
            <ci_upper_limit>25.19</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup C-Vaccine comparison at day 6 (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified</non_inferiority_desc>
            <param_type>Between group GMT ratios</param_type>
            <param_value>13.42</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>7.31</ci_lower_limit>
            <ci_upper_limit>24.66</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup C-Vaccine comparison at day 6 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified</non_inferiority_desc>
            <param_type>Between group GMT ratios</param_type>
            <param_value>13.59</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>7.70</ci_lower_limit>
            <ci_upper_limit>24.00</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup C-Vaccine comparison at day 6 (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified</non_inferiority_desc>
            <param_type>Between group GMT ratios</param_type>
            <param_value>1.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.67</ci_lower_limit>
            <ci_upper_limit>1.56</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup C-Vaccine comparison at day 29 (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified</non_inferiority_desc>
            <param_type>Between group GMT ratios</param_type>
            <param_value>19.43</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>13.73</ci_lower_limit>
            <ci_upper_limit>27.51</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup C-Vaccine comparison at day 29 (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified</non_inferiority_desc>
            <param_type>Between group GMT ratios</param_type>
            <param_value>17.72</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>12.50</ci_lower_limit>
            <ci_upper_limit>25.12</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup C-Vaccine comparison at day 29 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified</non_inferiority_desc>
            <param_type>Between group GMT ratios</param_type>
            <param_value>18.57</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>13.40</ci_lower_limit>
            <ci_upper_limit>25.73</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup C-Vaccine comparison at day 29 (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified</non_inferiority_desc>
            <param_type>Between group GMT ratios</param_type>
            <param_value>1.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.86</ci_lower_limit>
            <ci_upper_limit>1.40</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup W-Vaccine comparison at day 4 (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified</non_inferiority_desc>
            <param_type>Between group GMT ratios</param_type>
            <param_value>1.88</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.13</ci_lower_limit>
            <ci_upper_limit>3.11</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup W-Vaccine comparison at day 4 (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified</non_inferiority_desc>
            <param_type>Between group GMT ratios</param_type>
            <param_value>2.46</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.48</ci_lower_limit>
            <ci_upper_limit>4.08</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup W-Vaccine comparison at day 4 - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified</non_inferiority_desc>
            <param_type>Between group GMT ratios</param_type>
            <param_value>2.14</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.33</ci_lower_limit>
            <ci_upper_limit>3.44</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup W-Vaccine comparison at day 4 (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified</non_inferiority_desc>
            <param_type>Between group GMT ratios</param_type>
            <param_value>0.76</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.53</ci_lower_limit>
            <ci_upper_limit>1.10</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup W-Vaccine comparison at day 6 (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified</non_inferiority_desc>
            <param_type>Between group GMT ratios</param_type>
            <param_value>7.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>4.05</ci_lower_limit>
            <ci_upper_limit>12.22</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup W-Vaccine comparison at day 6 (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified</non_inferiority_desc>
            <param_type>Between group GMT ratios</param_type>
            <param_value>8.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>5.16</ci_lower_limit>
            <ci_upper_limit>15.66</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup W-Vaccine comparison at day 6 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified</non_inferiority_desc>
            <param_type>Between group GMT ratios</param_type>
            <param_value>7.94</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>4.72</ci_lower_limit>
            <ci_upper_limit>13.35</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup W-Vaccine comparison at day 6 (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified</non_inferiority_desc>
            <param_type>Between group GMT ratios</param_type>
            <param_value>0.78</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>1.14</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup W-Vaccine comparison at day 29 (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified</non_inferiority_desc>
            <param_type>Between group GMT ratios</param_type>
            <param_value>25.21</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>17.83</ci_lower_limit>
            <ci_upper_limit>35.65</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup W-Vaccine comparison at day 29 (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified</non_inferiority_desc>
            <param_type>Between group GMT ratios</param_type>
            <param_value>34.06</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>24.06</ci_lower_limit>
            <ci_upper_limit>48.23</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup W-Vaccine comparison at day 29 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified</non_inferiority_desc>
            <param_type>Between group GMT ratios</param_type>
            <param_value>29.24</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>21.09</ci_lower_limit>
            <ci_upper_limit>40.52</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup W-Vaccine comparison at day 29 (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified</non_inferiority_desc>
            <param_type>Between group GMT ratios</param_type>
            <param_value>0.74</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.58</ci_lower_limit>
            <ci_upper_limit>0.94</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y-Vaccine comparison at day 4 (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified</non_inferiority_desc>
            <param_type>Between group GMT ratios</param_type>
            <param_value>2.35</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.36</ci_lower_limit>
            <ci_upper_limit>4.07</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y-Vaccine comparison at day 4 (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified</non_inferiority_desc>
            <param_type>Between group GMT ratios</param_type>
            <param_value>2.62</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.51</ci_lower_limit>
            <ci_upper_limit>4.54</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y-Vaccine comparison at day 4 - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified</non_inferiority_desc>
            <param_type>Between group GMT ratios</param_type>
            <param_value>2.48</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.48</ci_lower_limit>
            <ci_upper_limit>4.14</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y-Vaccine comparison at day 4 (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified</non_inferiority_desc>
            <param_type>Between group GMT ratios</param_type>
            <param_value>0.90</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.61</ci_lower_limit>
            <ci_upper_limit>1.33</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y-Vaccine comparison at day 6 (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified</non_inferiority_desc>
            <param_type>Between group GMT ratios</param_type>
            <param_value>9.82</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>5.47</ci_lower_limit>
            <ci_upper_limit>17.64</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y-Vaccine comparison at day 6 (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified</non_inferiority_desc>
            <param_type>Between group GMT ratios</param_type>
            <param_value>9.55</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>5.31</ci_lower_limit>
            <ci_upper_limit>17.19</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y-Vaccine comparison at day 6 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified</non_inferiority_desc>
            <param_type>Between group GMT ratios</param_type>
            <param_value>9.69</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>5.59</ci_lower_limit>
            <ci_upper_limit>16.79</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y-Vaccine comparison at day 6 (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified</non_inferiority_desc>
            <param_type>Between group GMT ratios</param_type>
            <param_value>1.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.69</ci_lower_limit>
            <ci_upper_limit>1.54</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y-Vaccine comparison at day 29 (Menveo-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified</non_inferiority_desc>
            <param_type>Between group GMT ratios</param_type>
            <param_value>28.52</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>20.23</ci_lower_limit>
            <ci_upper_limit>40.20</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y-Vaccine comparison at day 29 (Menactra-Menveo vs. Naive)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified</non_inferiority_desc>
            <param_type>Between group GMT ratios</param_type>
            <param_value>26.94</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>19.09</ci_lower_limit>
            <ci_upper_limit>38.02</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y-Vaccine comparison at day 29 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified</non_inferiority_desc>
            <param_type>Between group GMT ratios</param_type>
            <param_value>27.73</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>20.10</ci_lower_limit>
            <ci_upper_limit>38.26</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y-Vaccine comparison at day 29 (Menveo-Menveo vs. Menactra-Menveo)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified</non_inferiority_desc>
            <param_type>Between group GMT ratios</param_type>
            <param_value>1.06</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.83</ci_lower_limit>
            <ci_upper_limit>1.35</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Within Group hSBA Geometric Mean Ratios (GMRs)</title>
        <description>Within each study group and for each serogroup, GMRs were calculated,at: Visit Day 4 versus at Visit Day 1; Visit Day 6 versus at Visit Day 1; and Visit Day 29 versus at Visit Day 1. The unadjusted GMRs and 95% CIs are constructed by exponentiating the mean within-group differences in log-transformed titers and the corresponding 95% CIs.</description>
        <time_frame>At Day 4, Day 6, Day 29 compared to Day 1</time_frame>
        <population>Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup</population>
        <group_list>
          <group group_id="O1">
            <title>Menveo-Menveo Group</title>
            <description>Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Menactra-Menveo Group</title>
            <description>Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.</description>
          </group>
          <group group_id="O3">
            <title>Pooled Group (Menveo-Menveo and Menactra-Menveo)</title>
            <description>Pooled subjects from both Menveo-Menveo and Menactra-Menveo Groups</description>
          </group>
          <group group_id="O4">
            <title>Naive Group</title>
            <description>Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Within Group hSBA Geometric Mean Ratios (GMRs)</title>
          <description>Within each study group and for each serogroup, GMRs were calculated,at: Visit Day 4 versus at Visit Day 1; Visit Day 6 versus at Visit Day 1; and Visit Day 29 versus at Visit Day 1. The unadjusted GMRs and 95% CIs are constructed by exponentiating the mean within-group differences in log-transformed titers and the corresponding 95% CIs.</description>
          <population>Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup</population>
          <units>Ratios</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="289"/>
                <count group_id="O2" value="282"/>
                <count group_id="O3" value="571"/>
                <count group_id="O4" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>hSBA-Men A, Day 4/Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="144"/>
                    <count group_id="O2" value="138"/>
                    <count group_id="O3" value="282"/>
                    <count group_id="O4" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.02" lower_limit="0.93" upper_limit="1.12"/>
                    <measurement group_id="O2" value="1.07" lower_limit="0.97" upper_limit="1.17"/>
                    <measurement group_id="O3" value="1.04" lower_limit="0.98" upper_limit="1.11"/>
                    <measurement group_id="O4" value="0.99" lower_limit="0.84" upper_limit="1.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men A, Day 6/Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="145"/>
                    <count group_id="O2" value="140"/>
                    <count group_id="O3" value="285"/>
                    <count group_id="O4" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.58" lower_limit="3.49" upper_limit="6"/>
                    <measurement group_id="O2" value="3.25" lower_limit="2.46" upper_limit="4.28"/>
                    <measurement group_id="O3" value="3.87" lower_limit="3.19" upper_limit="4.7"/>
                    <measurement group_id="O4" value="1.09" lower_limit="0.66" upper_limit="1.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men A, Day 29/Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="289"/>
                    <count group_id="O2" value="282"/>
                    <count group_id="O3" value="571"/>
                    <count group_id="O4" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.02" lower_limit="63.87" upper_limit="88.12"/>
                    <measurement group_id="O2" value="80.13" lower_limit="68.09" upper_limit="94.3"/>
                    <measurement group_id="O3" value="77.5" lower_limit="69.12" upper_limit="86.9"/>
                    <measurement group_id="O4" value="14.14" lower_limit="10.65" upper_limit="18.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men C, Day 4/Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="143"/>
                    <count group_id="O2" value="137"/>
                    <count group_id="O3" value="280"/>
                    <count group_id="O4" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.12" lower_limit="0.99" upper_limit="1.28"/>
                    <measurement group_id="O2" value="1.35" lower_limit="1.19" upper_limit="1.54"/>
                    <measurement group_id="O3" value="1.23" lower_limit="1.12" upper_limit="1.35"/>
                    <measurement group_id="O4" value="1.21" lower_limit="0.97" upper_limit="1.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men C, Day 6/Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="144"/>
                    <count group_id="O2" value="139"/>
                    <count group_id="O3" value="283"/>
                    <count group_id="O4" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.25" lower_limit="5.39" upper_limit="9.75"/>
                    <measurement group_id="O2" value="7.94" lower_limit="5.87" upper_limit="10.73"/>
                    <measurement group_id="O3" value="7.58" lower_limit="6.14" upper_limit="9.36"/>
                    <measurement group_id="O4" value="1.45" lower_limit="0.85" upper_limit="2.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men C, Day 29/Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="288"/>
                    <count group_id="O2" value="280"/>
                    <count group_id="O3" value="568"/>
                    <count group_id="O4" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.72" lower_limit="58.88" upper_limit="87.37"/>
                    <measurement group_id="O2" value="97.13" lower_limit="79.51" upper_limit="118.65"/>
                    <measurement group_id="O3" value="83.29" lower_limit="72.34" upper_limit="95.89"/>
                    <measurement group_id="O4" value="11.81" lower_limit="8.34" upper_limit="16.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men W, Day 4/Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="144"/>
                    <count group_id="O2" value="138"/>
                    <count group_id="O3" value="282"/>
                    <count group_id="O4" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.05" lower_limit="0.91" upper_limit="1.23"/>
                    <measurement group_id="O2" value="1.4" lower_limit="1.2" upper_limit="1.63"/>
                    <measurement group_id="O3" value="1.21" lower_limit="1.09" upper_limit="1.35"/>
                    <measurement group_id="O4" value="1.14" lower_limit="0.88" upper_limit="1.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men W, Day 6/Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="145"/>
                    <count group_id="O2" value="140"/>
                    <count group_id="O3" value="285"/>
                    <count group_id="O4" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.71" lower_limit="4.37" upper_limit="7.45"/>
                    <measurement group_id="O2" value="6.27" lower_limit="4.78" upper_limit="8.23"/>
                    <measurement group_id="O3" value="5.98" lower_limit="4.95" upper_limit="7.23"/>
                    <measurement group_id="O4" value="1.32" lower_limit="0.81" upper_limit="2.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men W, Day 29/Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="289"/>
                    <count group_id="O2" value="281"/>
                    <count group_id="O3" value="570"/>
                    <count group_id="O4" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.63" lower_limit="51.37" upper_limit="78.81"/>
                    <measurement group_id="O2" value="80.61" lower_limit="64.88" upper_limit="100.14"/>
                    <measurement group_id="O3" value="71.5" lower_limit="61.38" upper_limit="83.27"/>
                    <measurement group_id="O4" value="4.57" lower_limit="3.13" upper_limit="6.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men Y, Day 4/Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="142"/>
                    <count group_id="O2" value="137"/>
                    <count group_id="O3" value="279"/>
                    <count group_id="O4" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.35" lower_limit="1.15" upper_limit="1.59"/>
                    <measurement group_id="O2" value="1.31" lower_limit="1.11" upper_limit="1.54"/>
                    <measurement group_id="O3" value="1.33" lower_limit="1.19" upper_limit="1.49"/>
                    <measurement group_id="O4" value="0.99" lower_limit="0.75" upper_limit="1.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men Y, Day 6/Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="143"/>
                    <count group_id="O2" value="140"/>
                    <count group_id="O3" value="283"/>
                    <count group_id="O4" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.09" lower_limit="4.53" upper_limit="8.19"/>
                    <measurement group_id="O2" value="8.59" lower_limit="6.37" upper_limit="11.59"/>
                    <measurement group_id="O3" value="7.22" lower_limit="5.85" upper_limit="8.92"/>
                    <measurement group_id="O4" value="1.48" lower_limit="0.87" upper_limit="2.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hSBA-Men Y, Day 29/Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="287"/>
                    <count group_id="O2" value="280"/>
                    <count group_id="O3" value="567"/>
                    <count group_id="O4" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="116.58" lower_limit="94.42" upper_limit="143.95"/>
                    <measurement group_id="O2" value="123.41" lower_limit="99.69" upper_limit="152.78"/>
                    <measurement group_id="O3" value="119.91" lower_limit="103.21" upper_limit="139.3"/>
                    <measurement group_id="O4" value="8.21" lower_limit="5.67" upper_limit="11.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Solicited AEs were assessed between 6 hours through Day 7. Unsolicited AEs were assessed between Day 1 trough Day 29. SAEs were assessed during the entire study period (from Day 1 to Day 181).</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Menveo-Menveo Group</title>
          <description>Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.</description>
        </group>
        <group group_id="E2">
          <title>Menactra-Menveo Group</title>
          <description>Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.</description>
        </group>
        <group group_id="E3">
          <title>Naive Group</title>
          <description>Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 20.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="301"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Intentional overdose</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic ketoacidotic hyperglycaemic coma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Abortion spontaneous</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Suicide attempt</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Major depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 20.1</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="243" subjects_at_risk="301"/>
                <counts group_id="E2" subjects_affected="211" subjects_at_risk="300"/>
                <counts group_id="E3" subjects_affected="60" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Tympanic membrane perforation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Cerumen impaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Middle ear effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Oculogyric crisis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Retinal tear</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Conjunctivitis allergic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Eye disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Erythema of eyelid</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="65" subjects_affected="51" subjects_at_risk="301"/>
                <counts group_id="E2" events="55" subjects_affected="44" subjects_at_risk="300"/>
                <counts group_id="E3" events="17" subjects_affected="15" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="301"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="301"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Tooth impacted</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Abdominal tenderness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Food poisoning</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Anal skin tags</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Eosinophilic oesophagitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Salivary gland mucocoele</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Umbilical hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" events="124" subjects_affected="119" subjects_at_risk="301"/>
                <counts group_id="E2" events="113" subjects_affected="106" subjects_at_risk="300"/>
                <counts group_id="E3" events="41" subjects_affected="41" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="146" subjects_affected="116" subjects_at_risk="301"/>
                <counts group_id="E2" events="159" subjects_affected="111" subjects_at_risk="300"/>
                <counts group_id="E3" events="21" subjects_affected="19" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="36" subjects_affected="34" subjects_at_risk="301"/>
                <counts group_id="E2" events="50" subjects_affected="37" subjects_at_risk="300"/>
                <counts group_id="E3" events="10" subjects_affected="10" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Injection site induration</sub_title>
                <counts group_id="E1" events="17" subjects_affected="17" subjects_at_risk="301"/>
                <counts group_id="E2" events="11" subjects_affected="10" subjects_at_risk="300"/>
                <counts group_id="E3" events="9" subjects_affected="8" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" events="16" subjects_affected="14" subjects_at_risk="301"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="300"/>
                <counts group_id="E3" events="14" subjects_affected="11" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="301"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="300"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Injection site pruritus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Medical device site erythema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Medical device site swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Injection site swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Vaccination site pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Axillary pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Injection site bruising</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Biliary dyskinesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Anaphylactic reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Allergy to animal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="16" subjects_affected="13" subjects_at_risk="301"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="300"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="301"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="300"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Acute sinusitis</sub_title>
                <counts group_id="E1" events="13" subjects_affected="11" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="301"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="301"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="300"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Pneumonia mycoplasmal</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="301"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="300"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="301"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="300"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Pharyngitis streptococcal</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="301"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Viral pharyngitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="301"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Otitis media acute</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="301"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="300"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="301"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="300"/>
                <counts group_id="E3" events="4" subjects_affected="2" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Otitis externa</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Tooth abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Bronchitis viral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Croup infectious</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Hordeolum</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Laryngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Pneumonia bacterial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection viral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Viral rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Vulvovaginal candidiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Bacterial vaginosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Bartholin's abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Chlamydial infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Fungal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Infectious mononucleosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Subcutaneous abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Kidney infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Vaginal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Vulvovaginal mycotic infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="301"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Arthropod bite</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Concussion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="301"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Meniscus injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Joint injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Arthropod sting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Ligament rupture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Post procedural complication</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Hand fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Alcohol poisoning</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Conjunctival abrasion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Facial bones fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Joint dislocation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Muscle strain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Pulmonary contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Foot fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Cardiac murmur</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="50" subjects_affected="37" subjects_at_risk="301"/>
                <counts group_id="E2" events="63" subjects_affected="48" subjects_at_risk="300"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Vitamin D deficiency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="63" subjects_affected="57" subjects_at_risk="301"/>
                <counts group_id="E2" events="72" subjects_affected="55" subjects_at_risk="300"/>
                <counts group_id="E3" events="15" subjects_affected="15" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="60" subjects_affected="46" subjects_at_risk="301"/>
                <counts group_id="E2" events="50" subjects_affected="41" subjects_at_risk="300"/>
                <counts group_id="E3" events="13" subjects_affected="13" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Metatarsalgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Myalgia intercostal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Rheumatoid arthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Synovial cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Joint stiffness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Pain in jaw</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Groin pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Muscle tightness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Benign bone neoplasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Skin papilloma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="135" subjects_affected="103" subjects_at_risk="301"/>
                <counts group_id="E2" events="118" subjects_affected="84" subjects_at_risk="300"/>
                <counts group_id="E3" events="27" subjects_affected="23" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="301"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Loss of consciousness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Migraine with aura</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Tension headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="301"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Attention deficit/hyperactivity disorder</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="301"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Major depression</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Sleep disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Disruptive mood dysregulation disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Post-traumatic stress disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Polyuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Menstruation irregular</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Dysmenorrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Metrorrhagia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Pelvic congestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="301"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="300"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="301"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="300"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="301"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="301"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Sinus congestion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Snoring</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Dysphonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Pulmonary congestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Rhonchi</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Upper-airway cough syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="301"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Ecchymosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Rash macular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Lymphangiopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Essential hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="301"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </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>GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>GSK Response Center</name_or_title>
      <organization>GlaxoSmithKline</organization>
      <phone>866-435-7343</phone>
      <email>mb116236@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/NCT02986854
org study id: 205352
secondary id: V59_77
secondary id: 2016-003186-25
nct id: NCT02986854
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
The purpose/aim of this study is to assess the safety and antibody response to vaccination
      with a booster dose of Menveo given 4-6 years after primary MenACWY vaccination and to assess
      the safety and antibody response to a single dose of Menveo given to vaccine-naïve subjects
This is a phase 3b, controlled, open-label, multi-center study to evaluate safety and
      immunogenicity of Menveo after a single vaccination in healthy individuals who were
      vaccinated with Menveo or Menactra 4 to 6 years before and in vaccine-naive individuals.
      Vaccine-naive subjects: subjects who have not received any meningococcal vaccine prior to
      participation to this clinical trial.

      Subjects will be randomised into one of the two different blood draw schedules according to a
      1:1 ratio.

        -  Blood draws at Day 1, Day 4 and Day 29

        -  Blood draws at Day 1, Day 6 and Day 29
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y.
time frame: At Day 29
description: Seroresponse was defined as follows:for subjects with pre-vaccination hSBA titers< 4,postvaccination hSBA titers≥16;for subjects with pre-vaccination hSBA titers≥4,post vaccination hSBA titers of atleast 4 times the pre-vaccination titers.Criteria to demonstrate primary objectives:Immune response sufficiency was tested sequentially;first in the group of subjects who received primary vaccination with Menveo &,if met,also in group of subjects who received primary vaccination with Menactra.Immune response is considered sufficient if lower limit of the 1-sided 97.5% CI for percentage of subjects with hSBA seroresponse against serogroups A, C, W & Y is greater than 75%.Study is considered successful if immune response sufficiency is demonstrated atleast in group of subjects who received primary vaccination with Menveo.This outcome measure was assessed only on subjects from Menveo-Menveo & Menactra-Menveo groups.Data from pooled and Naive groups are presented as part of secondary objectives
measure: Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
time frame: Within 30 minutes after vaccination
description: An AE can be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom , or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product. An unsolicited adverse event is an adverse event that was not solicited using a subject diary and that was spontaneously communicated by a subject and/or parent(s)/legal guardian(s) who has signed the informed consent.
measure: Number of Subjects Reporting Solicited Local and Systemic AEs
time frame: From Day 1 (6 hours) through Day 7 after vaccination
description: Assessed solicited local symptoms were injection site pain, erythema, induration. Assessed solicited systemic symptoms were fatigue, headache, myalgia, arthralgia, loss of appetite, nausea, chills and fever [defined and measured by a body temperature ≥37.5 degrees Celsius (ºC)]. Threshold for Erythema and Induration: Grade 0 (<25 mm), Any (>= 25 mm)
measure: Number of Subjects Reporting Other Indicators of Reactogenicity
time frame: From Day 1 (6 hours) through Day 7 after vaccination
description: Assessed indicators of reactogenicity were use of analgesics/antipyretics for prophylaxis, use of analgesics/antipyretics for treatment, body temperature (described as 0.5 °C increments from ≥ 36.0ºC)
measure: Number of Subjects Reporting All Unsolicited AEs
time frame: From Day 1 through Day 29 after vaccination
description: An AE can be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom , or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product. An unsolicited adverse event was an adverse event that was not solicited using a subject diary and that was spontaneously communicated by a subject and/or parent(s)/legal guardian(s) who has signed the informed consent.
measure: Number of Subjects Reporting Medically-attended AEs (MAAEs), AEs Leading to Withdrawal and Serious AEs (SAEs)
time frame: From Day 1 through Day 181 (entire study period)
description: Medically attended AEs were defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider.
SAE was defined as any untoward medical occurrence that at any dose resulted in: death, was life-threatening, required or prolonged hospitalization, persistent or significant disability/incapacity, congenital anomaly/or birth defect, an important and significant medical event that might not have been immediately life threatening or resulting in death or hospitalization but, based upon appropriate medical judgment, might jeopardized the subject or might required intervention to prevent one of the other outcomes listed.
measure: Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup A
time frame: At Day 1 (pre-vaccination), Day 4, Day 6 and Day 29
description: For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated.
measure: Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup C
time frame: At day 1(pre-vaccination) , day 4, day 6 and day 29
description: For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated.
measure: Percentage of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup W
time frame: At day 1(pre-vaccination), day 4, day 6 and day 29
description: For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated.
measure: Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup Y
time frame: At day 1(pre-vaccination), day 4, day 6 and day 29
description: For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated.
measure: Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup A
time frame: At day 1(pre-vaccination), day 4, day 6 and day 29
description: For each study group and in the pooled group, percentages of subjects with hSBA titer ≥16 and associated two-sided 95%CIs were calculated.
measure: Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup C
time frame: At day 1(pre-vaccination) , day 4, day 6 and day 29
description: Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup
measure: Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup W
time frame: At day 1(pre-vaccination), day 4, day 6 and day 29
description: For each study group and in the pooled group, percentages of subjects with hSBA titer ≥16 and associated two-sided 95%CIs were calculated.
measure: Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup Y
time frame: At day 1(pre-vaccination) , day 4, day 6 and day 29
description: For each study group and in the pooled group, percentages of subjects with hSBA titer ≥16 and associated two-sided 95%CIs were calculated.
measure: Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y
time frame: At Day 4 and Day 6
description: Seroresponse is defined for this study as follows: For subjects with pre-vaccination titers <4, postvaccination titers ≥ 16; for subjects with pre-vaccination titers ≥4, post vaccination titers at least 4 times the pre-vaccination titers.
measure: hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y.
time frame: At Day 1 (pre-vaccination), Day 4, Day 6 and Day 29
description: For each N. meningitidis serogroup A, C, W and Y, unadjusted GMTs were calculated, with their associated two-sided 95% Confidence Interval.
measure: Within Group hSBA Geometric Mean Ratios (GMRs)
time frame: At Day 4, Day 6, Day 29 compared to Day 1
description: Within each study group and for each serogroup, GMRs were calculated,at: Visit Day 4 versus at Visit Day 1; Visit Day 6 versus at Visit Day 1; and Visit Day 29 versus at Visit Day 1. The unadjusted GMRs and 95% CIs are constructed by exponentiating the mean within-group differences in log-transformed titers and the corresponding 95% CIs.
arm group label: Menveo-Menveo Group
arm group type: Experimental
description: Approximately 300 subjects, who were vaccinated with a single dose of Menveo 4 to 6 years before, will receive one dose of MenACWY-CRM at Day 1.
arm group label: Menactra-Menveo Group
arm group type: Experimental
description: Approximately 300 subjects, who were vaccinated with a single dose of Menactra 4 to 6 years before, will receive one dose of MenACWY-CRM at Day 1.
arm group label: Naive Group
arm group type: Active Comparator
description: Aproximately 100 subjects, of similar age to subjects enrolled in other primed groups, who have not received any meningococcal vaccination, will receive one dose of MenACWY-CRM at Day 1.
intervention type: Biological
intervention name: Meningococcal (groups A, C, W and Y) oligosaccharide diphtheria CRM-197 conjugate Vaccine (Menveo)
description: One intramuscular injection of MenACWY at Day 1.
arm group label: Menactra-Menveo Group
arm group label: Menveo-Menveo Group
arm group label: Naive Group
criteria: 
gender: All
minimum age: 15 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Puerto Rico
country: United States
url: https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217381&amp;parentIdentifier=205352&amp;attachmentIdentifier=4b9c0f0f-df12-453e-bed2-1e14b1b278a1&amp;fileName=gsk-205352-clinical-study-report-redact.pdf&amp;versionIdentifier=
description: Full CSR posting on GSK
citation: Tipton M, Daly W, Senders S, Block SL, Lattanzi M, Mzolo T, Barbi S, Pellegrini M, Keshavan P. MenACWY-CRM conjugate vaccine booster dose given 4-6 years after priming: Results from a phase IIIb, multicenter, open label study in adolescents and adults. Vaccine. 2019 Sep 30;37(42):6171-6179. doi: 10.1016/j.vaccine.2019.08.065. Epub 2019 Sep 5.
PMID: 31495595
responsible party type: Sponsor
mesh term: Meningococcal Infections
sharing ipd: Yes
ipd description: IPD is available via the Clinical Study Data Request site (click on the link provided below)
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
ipd access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
ipd url: https://clinicalstudydatarequest.com/Posting.aspx?ID=20103
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 