<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/NCT01732627</url>
  </required_header>
  <id_info>
    <org_study_id>MET44</org_study_id>
    <secondary_id>U1111-1127-6804</secondary_id>
    <nct_id>NCT01732627</nct_id>
  </id_info>
  <brief_title>Study of a Quadrivalent Meningococcal Conjugate Vaccine in Subjects Aged 56 and Older</brief_title>
  <official_title>Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered in Subjects 56 Years of Age and Older</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sanofi Pasteur, a Sanofi Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sanofi</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary objectives:&#xD;
&#xD;
        -  To describe the antibody responses to meningococcal serogroups A, C, Y, and W 135,&#xD;
           measured by serum bactericidal assay using human complement (hSBA) and baby rabbit&#xD;
           complement (rSBA), induced by a single dose of Meningococcal Polysaccharide (A, C, Y,&#xD;
           and W 135) Tetanus Protein (MenACYW) Conjugate vaccine or Menomune® - A/C/Y/W 135.&#xD;
&#xD;
        -  To describe the safety profile of a single dose of MenACYW Conjugate vaccine or&#xD;
           Menomune® - A/C/Y/W 135.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All participants received a single dose of their assigned vaccine on Day 0. They were&#xD;
      assessed for immunogenicity on Day 0 and Day 30, and monitored for safety throughout the&#xD;
      study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 12, 2012</start_date>
  <completion_date type="Actual">January 17, 2013</completion_date>
  <primary_completion_date type="Actual">January 17, 2013</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine</measure>
    <time_frame>Day 0 (pre-vaccination)</time_frame>
    <description>Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine</measure>
    <time_frame>Day 30 (post-vaccination)</time_frame>
    <description>Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine</measure>
    <time_frame>Day 30 (post-vaccination)</time_frame>
    <description>Vaccine seroresponse for serogroups A, C, Y, and W 135 was measured by hSBA assay method. Seroresponse was defined as post-vaccination hSBA titers ≥1:8 for participants with pre-vaccination hSBA titers less than (&lt;) 1:8, or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers ≥1:8.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by hSBA Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine</measure>
    <time_frame>Day 0 (pre-vaccination)</time_frame>
    <description>GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine</measure>
    <time_frame>Day 30 (post-vaccination)</time_frame>
    <description>GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune®</measure>
    <time_frame>Day 0 (pre-vaccination)</time_frame>
    <description>Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by rSBA assay method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune®</measure>
    <time_frame>Day 30 (post-vaccination)</time_frame>
    <description>Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by rSBA assay method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Vaccine Seroresponse Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine</measure>
    <time_frame>Day 30 (post-vaccination)</time_frame>
    <description>Vaccine seroresponse for serogroups A, C, Y, and W 135 was measured by rSBA assay method. Seroresponse was defined as post-vaccination rSBA titers ≥1:8 for participants with pre-vaccination rSBA titers &lt;1:8, or at least a 4-fold increase in rSBA titers from pre- to post-vaccination for participants with pre-vaccination rSBA titers ≥1:8.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by rSBA Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine</measure>
    <time_frame>Day 0 (pre-vaccination)</time_frame>
    <description>GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 antibody titers were measured by rSBA assay method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine</measure>
    <time_frame>Day 30 (post-vaccination)</time_frame>
    <description>GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 antibody titers were measured by rSBA assay method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Immediate Unsolicited Adverse Events (AEs) After Vaccination</measure>
    <time_frame>Within 30 minutes after vaccination</time_frame>
    <description>An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report form (CRF) in terms of symptom and/or onset post-vaccination. Unsolicited AEs includes both serious and non-serious unsolicited AEs. A serious adverse event (SAE) was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRF.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Solicited Injection Site Reactions and Systemic Reactions After Vaccination</measure>
    <time_frame>Within 7 days after vaccination</time_frame>
    <description>A solicited reaction (SR) was an adverse reaction (AR) observed and reported under the conditions (symptom and onset) prelisted in the CRF. Solicited injection site reactions included: pain, erythema, and swelling. Solicited systemic reactions included: fever, headache, malaise and, myalgia.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Unsolicited Adverse Events After Vaccination</measure>
    <time_frame>Within 30 days after vaccination</time_frame>
    <description>An unsolicited AE was an observed AE that does not fulfill the conditions prelisted in the CRF in terms of symptom and/or onset post-vaccination. Unsolicited AEs included both serious and non-serious unsolicited AEs. An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. Non-serious AE (AE excluding SAE) which was significant and prevented daily activity was considered as Grade 3 unsolicited non-serious AE.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">301</enrollment>
  <condition>Meningitis</condition>
  <condition>Meningococcal Meningitis</condition>
  <condition>Meningococcal Infections</condition>
  <condition>Invasive Meningococcal Disease</condition>
  <arm_group>
    <arm_group_label>Group 1: MenACYW Conjugate Vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adult participants aged greater than or equal to (≥) 56 years received a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W 135) Tetanus Toxoid (MenACYW) Conjugate vaccine on Day 0.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2: Menomune® A/C/Y/W 135 vaccine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Adult participants aged ≥56 years received a single dose of Meningococcal Polysaccharide Vaccine, Groups A, C, Y, and W 135 Combined (Menomune®) vaccine on Day 0.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Meningococcal Polysaccharide (A, C, Y, and W 135) Tetanus Protein Conjugate Vaccine</intervention_name>
    <description>0.5 milliliter (mL), Intramuscular (IM)</description>
    <arm_group_label>Group 1: MenACYW Conjugate Vaccine</arm_group_label>
    <other_name>MenACYW Conjugate Vaccine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W 135 Combined</intervention_name>
    <description>0.5 mL, Subcutaneous (SC)</description>
    <arm_group_label>Group 2: Menomune® A/C/Y/W 135 vaccine</arm_group_label>
    <other_name>Menomune® A/C/Y/W 135</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 56 or older on the day of inclusion.&#xD;
&#xD;
          -  Informed consent form had been signed and dated.&#xD;
&#xD;
          -  Able to attend all scheduled visits and complied with all trial procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participant was pregnant, or lactating, or of childbearing potential (were considered&#xD;
             of non-childbearing potential, a female must be post-menopausal for at least 1 year,&#xD;
             surgically sterile, or used an effective method of contraception or abstinence from at&#xD;
             least 4 weeks prior to vaccination and until at least 4 weeks after vaccination).&#xD;
&#xD;
          -  Participation at the time of study enrollment (or in the 4 weeks preceding the trial&#xD;
             vaccination) or planned participation during the present trial period in another&#xD;
             clinical trial investigating a vaccine, drug, medical device, or medical procedure.&#xD;
&#xD;
          -  Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned&#xD;
             receipt of any vaccine in the 4 weeks following the trial vaccination except for&#xD;
             influenza vaccination, which might be received at least 2 weeks before or after the&#xD;
             study vaccines.&#xD;
&#xD;
          -  Previous vaccination against meningococcal disease with either a trial vaccine or&#xD;
             another vaccine.&#xD;
&#xD;
          -  Receipt of immune globulins, blood or blood-derived products in the past 3 months.&#xD;
&#xD;
          -  Known or suspected congenital or acquired immunodeficiency; or receipt of&#xD;
             immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy,&#xD;
             within the preceding 6 months; or long-term systemic corticosteroid therapy&#xD;
             (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).&#xD;
&#xD;
          -  History of meningococcal infection, confirmed either clinically, serologically, or&#xD;
             microbiologically.&#xD;
&#xD;
          -  At high risk for meningococcal infection during the trial.&#xD;
&#xD;
          -  Known systemic hypersensitivity to latex or any of the vaccine components, or history&#xD;
             of a severe reaction to the vaccines used in the trial or to a vaccine containing any&#xD;
             of the same substances.&#xD;
&#xD;
          -  Personal history of Guillain-Barré syndrome.&#xD;
&#xD;
          -  Personal history of an Arthus-like reaction after vaccination with a tetanus&#xD;
             toxoid-containing vaccine within at least 10 years of the proposed study vaccination.&#xD;
&#xD;
          -  Self-reported thrombocytopenia, contraindicating IM vaccination.&#xD;
&#xD;
          -  Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,&#xD;
             contraindicating IM vaccination.&#xD;
&#xD;
          -  Deprived of freedom by an administrative or court order, or in an emergency setting,&#xD;
             or hospitalized involuntarily.&#xD;
&#xD;
          -  Current alcohol abuse or drug addiction.&#xD;
&#xD;
          -  Chronic illness that, in the opinion of the investigator, was at a stage where it&#xD;
             might interfere with trial conduct or completion.&#xD;
&#xD;
          -  Moderate or severe acute illness/infection (according to investigator judgment) on the&#xD;
             day of vaccination or febrile illness (temperature ≥ 100.4°Fahrenheit [≥&#xD;
             38.0°Celsius]). A prospective participant should not be included in the study until&#xD;
             the condition had resolved or the febrile event had subsided.&#xD;
&#xD;
          -  Receipt of oral or injectable antibiotic therapy within 3 days prior to any blood&#xD;
             draw. Should a participant receive oral or injectable antibiotic therapy within 3 days&#xD;
             prior to any blood draw, the Investigator would postpone the blood draw until it had&#xD;
             been 3 days since the participant last received oral or injectable antibiotic therapy.&#xD;
             Postponement must still be within the timeframe for blood draw indicated in the Table&#xD;
             of Study Procedures, when possible.&#xD;
&#xD;
          -  Identified as an Investigator or employee of the Investigator or study center with&#xD;
             direct involvement in the proposed study, or identified as an immediate family member&#xD;
             (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with&#xD;
             direct involvement in the proposed study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>56 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Sanofi Pasteur Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Chandler</city>
        <state>Arizona</state>
        <zip>85224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85251</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Milford</city>
        <state>Connecticut</state>
        <zip>06460</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Edina</city>
        <state>Minnesota</state>
        <zip>55435</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Anderson</city>
        <state>South Carolina</state>
        <zip>29621</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>West Jordan</city>
        <state>Utah</state>
        <zip>84088</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22911</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Kirstein J, Pina M, Pan J, Jordanov E, Dhingra MS. Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) in adults 56 years of age and older: a Phase II randomized study. Hum Vaccin Immunother. 2020 Jun 2;16(6):1299-1305. doi: 10.1080/21645515.2020.1733868. Epub 2020 Apr 1.</citation>
    <PMID>32233961</PMID>
  </results_reference>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>November 13, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 26, 2012</study_first_posted>
  <results_first_submitted>May 19, 2020</results_first_submitted>
  <results_first_submitted_qc>May 19, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">June 9, 2020</results_first_posted>
  <disposition_first_submitted>November 11, 2013</disposition_first_submitted>
  <disposition_first_submitted_qc>November 11, 2013</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">December 4, 2013</disposition_first_posted>
  <last_update_submitted>March 24, 2022</last_update_submitted>
  <last_update_submitted_qc>March 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Meningitis</keyword>
  <keyword>Meningococcal Meningitis</keyword>
  <keyword>Menactra®</keyword>
  <keyword>Menomune® A/C/Y/W 135</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Meningococcal Infections</mesh_term>
    <mesh_term>Meningitis, Meningococcal</mesh_term>
    <mesh_term>Meningitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaccines</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Study was conducted from 12-November-2012 to 17-January-2013 at 12 sites in the United States.</recruitment_details>
      <pre_assignment_details>A total of 301 participants were enrolled and vaccinated in the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Group 1: MenACYW Conjugate Vaccine</title>
          <description>Adult participants aged greater than or equal to (≥) 56 years received a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W 135) Tetanus Toxoid (MenACYW) Conjugate vaccine on Day 0.</description>
        </group>
        <group group_id="P2">
          <title>Group 2: Menomune® A/C/Y/W 135 Vaccine</title>
          <description>Adult participants aged ≥56 years received a single dose of Meningococcal Polysaccharide Vaccine, Groups A, C, Y, and W 135 Combined (Menomune®) vaccine on Day 0.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="201"/>
                <participants group_id="P2" count="100"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Analysis Set (SafAS)</title>
              <participants_list>
                <participants group_id="P1" count="199"/>
                <participants group_id="P2" count="100"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="200"/>
                <participants group_id="P2" count="100"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Analysis was performed on all randomized participants.</population>
      <group_list>
        <group group_id="B1">
          <title>Group 1: MenACYW Conjugate Vaccine</title>
          <description>Adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0.</description>
        </group>
        <group group_id="B2">
          <title>Group 2: Menomune® A/C/Y/W 135 Vaccine</title>
          <description>Adult participants aged ≥56 years received a single dose of Menomune® vaccine on Day 0.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="201"/>
            <count group_id="B2" value="100"/>
            <count group_id="B3" value="301"/>
          </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="66.0" spread="7.15"/>
                    <measurement group_id="B2" value="65.8" spread="6.58"/>
                    <measurement group_id="B3" value="65.9" spread="6.96"/>
                  </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="121"/>
                    <measurement group_id="B2" value="55"/>
                    <measurement group_id="B3" value="176"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="80"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="125"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="190"/>
                    <measurement group_id="B2" value="97"/>
                    <measurement group_id="B3" value="287"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine</title>
        <description>Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.</description>
        <time_frame>Day 0 (pre-vaccination)</time_frame>
        <population>Analysis was performed on Per-Protocol Analysis Set (PPAS) population which included participants who received at least one dose of the study vaccine, had any valid serology result, and no protocol deviations.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: MenACYW Conjugate Vaccine</title>
            <description>Adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Menomune® A/C/Y/W 135 Vaccine</title>
            <description>Adult participants aged ≥56 years received a single dose of Menomune® vaccine on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine</title>
          <description>Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.</description>
          <population>Analysis was performed on Per-Protocol Analysis Set (PPAS) population which included participants who received at least one dose of the study vaccine, had any valid serology result, and no protocol deviations.</population>
          <units>percentage of participants</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="195"/>
                <count group_id="O2" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serogroup A: ≥1:4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.9" lower_limit="92.1" upper_limit="98.2"/>
                    <measurement group_id="O2" value="96.8" lower_limit="91.0" upper_limit="99.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup A: ≥1:8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.4" lower_limit="69.8" upper_limit="82.2"/>
                    <measurement group_id="O2" value="79.8" lower_limit="70.2" upper_limit="87.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup C: ≥1:4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.7" lower_limit="21.5" upper_limit="34.5"/>
                    <measurement group_id="O2" value="30.9" lower_limit="21.7" upper_limit="41.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup C: ≥1:8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.4" lower_limit="12.4" upper_limit="23.5"/>
                    <measurement group_id="O2" value="10.6" lower_limit="5.2" upper_limit="18.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup Y: ≥1:4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.1" lower_limit="16.4" upper_limit="28.5"/>
                    <measurement group_id="O2" value="26.6" lower_limit="18.0" upper_limit="36.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup Y: ≥1:8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.3" lower_limit="8.9" upper_limit="18.9"/>
                    <measurement group_id="O2" value="24.5" lower_limit="16.2" upper_limit="34.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup W 135: ≥1:4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.2" lower_limit="20.1" upper_limit="32.9"/>
                    <measurement group_id="O2" value="26.6" lower_limit="18.0" upper_limit="36.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup W 135: ≥1:8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.3" lower_limit="8.9" upper_limit="18.9"/>
                    <measurement group_id="O2" value="8.5" lower_limit="3.7" upper_limit="16.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine</title>
        <description>Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.</description>
        <time_frame>Day 30 (post-vaccination)</time_frame>
        <population>Analysis was performed on PPAS population.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: MenACYW Conjugate Vaccine</title>
            <description>Adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Menomune® A/C/Y/W 135 Vaccine</title>
            <description>Adult participants aged ≥56 years received a single dose of Menomune® vaccine on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine</title>
          <description>Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.</description>
          <population>Analysis was performed on PPAS population.</population>
          <units>percentage of participants</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="195"/>
                <count group_id="O2" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serogroup A: ≥1:4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.4" lower_limit="94.1" upper_limit="99.2"/>
                    <measurement group_id="O2" value="93.6" lower_limit="86.6" upper_limit="97.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup A: ≥1:8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.8" lower_limit="89.5" upper_limit="96.8"/>
                    <measurement group_id="O2" value="85.1" lower_limit="76.3" upper_limit="91.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup C: ≥1:4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.6" lower_limit="79.9" upper_limit="90.2"/>
                    <measurement group_id="O2" value="79.8" lower_limit="70.2" upper_limit="87.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup C: ≥1:8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.9" lower_limit="68.2" upper_limit="80.8"/>
                    <measurement group_id="O2" value="62.8" lower_limit="52.2" upper_limit="72.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup Y: ≥1:4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.2" lower_limit="81.7" upper_limit="91.5"/>
                    <measurement group_id="O2" value="73.4" lower_limit="63.3" upper_limit="82.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup Y: ≥1:8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.5" lower_limit="74.2" upper_limit="85.8"/>
                    <measurement group_id="O2" value="59.6" lower_limit="49.0" upper_limit="69.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup W 135: ≥1:4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.7" lower_limit="83.4" upper_limit="92.8"/>
                    <measurement group_id="O2" value="77.7" lower_limit="67.9" upper_limit="85.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup W 135: ≥1:8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.5" lower_limit="73.1" upper_limit="84.9"/>
                    <measurement group_id="O2" value="60.6" lower_limit="50.0" upper_limit="70.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine</title>
        <description>Vaccine seroresponse for serogroups A, C, Y, and W 135 was measured by hSBA assay method. Seroresponse was defined as post-vaccination hSBA titers ≥1:8 for participants with pre-vaccination hSBA titers less than (&lt;) 1:8, or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers ≥1:8.</description>
        <time_frame>Day 30 (post-vaccination)</time_frame>
        <population>Analysis was performed on PPAS population.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: MenACYW Conjugate Vaccine</title>
            <description>Adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Menomune® A/C/Y/W 135 Vaccine</title>
            <description>Adult participants aged ≥56 years received a single dose of Menomune® vaccine on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine</title>
          <description>Vaccine seroresponse for serogroups A, C, Y, and W 135 was measured by hSBA assay method. Seroresponse was defined as post-vaccination hSBA titers ≥1:8 for participants with pre-vaccination hSBA titers less than (&lt;) 1:8, or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers ≥1:8.</description>
          <population>Analysis was performed on PPAS population.</population>
          <units>percentage of participants</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="195"/>
                <count group_id="O2" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serogroup A</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.1" lower_limit="58.0" upper_limit="71.8"/>
                    <measurement group_id="O2" value="46.8" lower_limit="36.4" upper_limit="57.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup C</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.8" lower_limit="63.8" upper_limit="77.0"/>
                    <measurement group_id="O2" value="59.6" lower_limit="49.0" upper_limit="69.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup Y</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.4" lower_limit="68.7" upper_limit="81.3"/>
                    <measurement group_id="O2" value="48.9" lower_limit="38.5" upper_limit="59.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup W 135</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.4" lower_limit="67.6" upper_limit="80.3"/>
                    <measurement group_id="O2" value="55.3" lower_limit="44.7" upper_limit="65.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by hSBA Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine</title>
        <description>GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.</description>
        <time_frame>Day 0 (pre-vaccination)</time_frame>
        <population>Analysis was performed on PPAS population.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: MenACYW Conjugate Vaccine</title>
            <description>Adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Menomune® A/C/Y/W 135 Vaccine</title>
            <description>Adult participants aged ≥56 years received a single dose of Menomune® vaccine on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by hSBA Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine</title>
          <description>GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.</description>
          <population>Analysis was performed on PPAS population.</population>
          <units>titers (1/dilution)</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="195"/>
                <count group_id="O2" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serogroup A</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.73" lower_limit="8.65" upper_limit="10.9"/>
                    <measurement group_id="O2" value="10.4" lower_limit="8.58" upper_limit="12.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup C</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.32" lower_limit="2.87" upper_limit="3.85"/>
                    <measurement group_id="O2" value="2.87" lower_limit="2.49" upper_limit="3.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup Y</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.02" lower_limit="2.63" upper_limit="3.47"/>
                    <measurement group_id="O2" value="3.53" lower_limit="2.84" upper_limit="4.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup W 135</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.83" lower_limit="2.56" upper_limit="3.14"/>
                    <measurement group_id="O2" value="2.83" lower_limit="2.40" upper_limit="3.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine</title>
        <description>GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.</description>
        <time_frame>Day 30 (post-vaccination)</time_frame>
        <population>Analysis was performed on PPAS population.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: MenACYW Conjugate Vaccine</title>
            <description>Adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Menomune® A/C/Y/W 135 Vaccine</title>
            <description>Adult participants aged ≥56 years received a single dose of Menomune® vaccine on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine</title>
          <description>GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.</description>
          <population>Analysis was performed on PPAS population.</population>
          <units>titers (1/dilution)</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="195"/>
                <count group_id="O2" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serogroup A</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.0" lower_limit="40.7" upper_limit="63.9"/>
                    <measurement group_id="O2" value="31.8" lower_limit="22.5" upper_limit="44.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup C</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.3" lower_limit="34.8" upper_limit="67.1"/>
                    <measurement group_id="O2" value="18.5" lower_limit="12.1" upper_limit="28.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup Y</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.9" lower_limit="31.8" upper_limit="55.3"/>
                    <measurement group_id="O2" value="16.6" lower_limit="11.3" upper_limit="24.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup W 135</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.0" lower_limit="22.5" upper_limit="37.3"/>
                    <measurement group_id="O2" value="17.1" lower_limit="11.6" upper_limit="25.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune®</title>
        <description>Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by rSBA assay method.</description>
        <time_frame>Day 0 (pre-vaccination)</time_frame>
        <population>Analysis was performed on PPAS population. Here, 'Number analyzed' = participants with available data for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: MenACYW Conjugate Vaccine</title>
            <description>Adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Menomune® A/C/Y/W 135 Vaccine</title>
            <description>Adult participants aged ≥56 years received a single dose of Menomune® vaccine on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune®</title>
          <description>Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by rSBA assay method.</description>
          <population>Analysis was performed on PPAS population. Here, 'Number analyzed' = participants with available data for each specified category.</population>
          <units>percentage of participants</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="195"/>
                <count group_id="O2" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serogroup A: ≥1:8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="195"/>
                    <count group_id="O2" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.2" lower_limit="22.0" upper_limit="35.1"/>
                    <measurement group_id="O2" value="26.9" lower_limit="18.2" upper_limit="37.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup A: ≥1:128</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="195"/>
                    <count group_id="O2" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.1" lower_limit="16.4" upper_limit="28.5"/>
                    <measurement group_id="O2" value="22.6" lower_limit="14.6" upper_limit="32.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup C: ≥1:8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="195"/>
                    <count group_id="O2" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.3" lower_limit="8.0" upper_limit="17.8"/>
                    <measurement group_id="O2" value="9.6" lower_limit="4.5" upper_limit="17.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup C: ≥1:128</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="195"/>
                    <count group_id="O2" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.2" lower_limit="4.8" upper_limit="13.0"/>
                    <measurement group_id="O2" value="4.3" lower_limit="1.2" upper_limit="10.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup Y: ≥1:8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="195"/>
                    <count group_id="O2" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.3" lower_limit="43.0" upper_limit="57.5"/>
                    <measurement group_id="O2" value="50.0" lower_limit="39.5" upper_limit="60.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup Y: ≥1:128</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="195"/>
                    <count group_id="O2" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.7" lower_limit="21.5" upper_limit="34.5"/>
                    <measurement group_id="O2" value="20.2" lower_limit="12.6" upper_limit="29.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup W 135: ≥1:8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="195"/>
                    <count group_id="O2" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.0" lower_limit="14.6" upper_limit="26.3"/>
                    <measurement group_id="O2" value="27.7" lower_limit="18.9" upper_limit="37.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup W 135: ≥1:128</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="195"/>
                    <count group_id="O2" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.8" lower_limit="8.5" upper_limit="18.3"/>
                    <measurement group_id="O2" value="14.9" lower_limit="8.4" upper_limit="23.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune®</title>
        <description>Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by rSBA assay method.</description>
        <time_frame>Day 30 (post-vaccination)</time_frame>
        <population>Analysis was performed on PPAS population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: MenACYW Conjugate Vaccine</title>
            <description>Adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Menomune® A/C/Y/W 135 Vaccine</title>
            <description>Adult participants aged ≥56 years received a single dose of Menomune® vaccine on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune®</title>
          <description>Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by rSBA assay method.</description>
          <population>Analysis was performed on PPAS population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.</population>
          <units>percentage of participants</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="193"/>
                <count group_id="O2" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serogroup A: ≥1:8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.9" lower_limit="92.0" upper_limit="98.2"/>
                    <measurement group_id="O2" value="94.7" lower_limit="88.0" upper_limit="98.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup A: ≥1:128</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.3" lower_limit="90.0" upper_limit="97.1"/>
                    <measurement group_id="O2" value="89.4" lower_limit="81.3" upper_limit="94.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup C: ≥1:8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.9" lower_limit="92.0" upper_limit="98.2"/>
                    <measurement group_id="O2" value="87.2" lower_limit="78.8" upper_limit="93.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup C: ≥1:128</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.3" lower_limit="88.8" upper_limit="96.4"/>
                    <measurement group_id="O2" value="77.7" lower_limit="67.9" upper_limit="85.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup Y: ≥1:8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.4" lower_limit="94.1" upper_limit="99.2"/>
                    <measurement group_id="O2" value="94.7" lower_limit="88.0" upper_limit="98.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup Y: ≥1:128</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.1" lower_limit="82.7" upper_limit="92.3"/>
                    <measurement group_id="O2" value="73.4" lower_limit="63.3" upper_limit="82.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup W 135: ≥1:8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.4" lower_limit="95.5" upper_limit="99.7"/>
                    <measurement group_id="O2" value="94.7" lower_limit="88.0" upper_limit="98.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup W 135: ≥1:128</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.3" lower_limit="90.0" upper_limit="97.1"/>
                    <measurement group_id="O2" value="79.8" lower_limit="70.2" upper_limit="87.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Vaccine Seroresponse Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine</title>
        <description>Vaccine seroresponse for serogroups A, C, Y, and W 135 was measured by rSBA assay method. Seroresponse was defined as post-vaccination rSBA titers ≥1:8 for participants with pre-vaccination rSBA titers &lt;1:8, or at least a 4-fold increase in rSBA titers from pre- to post-vaccination for participants with pre-vaccination rSBA titers ≥1:8.</description>
        <time_frame>Day 30 (post-vaccination)</time_frame>
        <population>Analysis was performed on PPAS population. Here, 'Number analyzed' = participants with available data for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: MenACYW Conjugate Vaccine</title>
            <description>Adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Menomune® A/C/Y/W 135 Vaccine</title>
            <description>Adult participants aged ≥56 years received a single dose of Menomune® vaccine on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Vaccine Seroresponse Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine</title>
          <description>Vaccine seroresponse for serogroups A, C, Y, and W 135 was measured by rSBA assay method. Seroresponse was defined as post-vaccination rSBA titers ≥1:8 for participants with pre-vaccination rSBA titers &lt;1:8, or at least a 4-fold increase in rSBA titers from pre- to post-vaccination for participants with pre-vaccination rSBA titers ≥1:8.</description>
          <population>Analysis was performed on PPAS population. Here, 'Number analyzed' = participants with available data for each specified category.</population>
          <units>percentage of participants</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="195"/>
                <count group_id="O2" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serogroup A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="193"/>
                    <count group_id="O2" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.2" lower_limit="85.1" upper_limit="94.0"/>
                    <measurement group_id="O2" value="89.2" lower_limit="81.1" upper_limit="94.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup C</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="193"/>
                    <count group_id="O2" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.8" lower_limit="90.7" upper_limit="97.5"/>
                    <measurement group_id="O2" value="86.2" lower_limit="77.5" upper_limit="92.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup Y</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="193"/>
                    <count group_id="O2" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.5" lower_limit="80.9" upper_limit="91.0"/>
                    <measurement group_id="O2" value="75.5" lower_limit="65.6" upper_limit="83.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup W 135</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="193"/>
                    <count group_id="O2" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.3" lower_limit="91.3" upper_limit="97.8"/>
                    <measurement group_id="O2" value="90.4" lower_limit="82.6" upper_limit="95.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by rSBA Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine</title>
        <description>GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 antibody titers were measured by rSBA assay method.</description>
        <time_frame>Day 0 (pre-vaccination)</time_frame>
        <population>Analysis was performed on PPAS population. Here, 'Number analyzed' = participants with available data for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: MenACYW Conjugate Vaccine</title>
            <description>Adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Menomune® A/C/Y/W 135 Vaccine</title>
            <description>Adult participants aged ≥56 years received a single dose of Menomune® vaccine on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by rSBA Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine</title>
          <description>GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 antibody titers were measured by rSBA assay method.</description>
          <population>Analysis was performed on PPAS population. Here, 'Number analyzed' = participants with available data for each specified category.</population>
          <units>titers (1/dilution)</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="195"/>
                <count group_id="O2" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serogroup A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="195"/>
                    <count group_id="O2" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.75" lower_limit="5.65" upper_limit="10.6"/>
                    <measurement group_id="O2" value="7.32" lower_limit="4.62" upper_limit="11.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup C</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="195"/>
                    <count group_id="O2" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.40" lower_limit="2.76" upper_limit="4.18"/>
                    <measurement group_id="O2" value="2.93" lower_limit="2.28" upper_limit="3.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup Y</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="195"/>
                    <count group_id="O2" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.3" lower_limit="11.4" upper_limit="20.7"/>
                    <measurement group_id="O2" value="13.1" lower_limit="8.63" upper_limit="19.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup W 135</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="195"/>
                    <count group_id="O2" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.74" lower_limit="3.68" upper_limit="6.12"/>
                    <measurement group_id="O2" value="6.05" lower_limit="4.11" upper_limit="8.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine</title>
        <description>GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 antibody titers were measured by rSBA assay method.</description>
        <time_frame>Day 30 (post-vaccination)</time_frame>
        <population>Analysis was performed on PPAS population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: MenACYW Conjugate Vaccine</title>
            <description>Adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Menomune® A/C/Y/W 135 Vaccine</title>
            <description>Adult participants aged ≥56 years received a single dose of Menomune® vaccine on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine</title>
          <description>GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 antibody titers were measured by rSBA assay method.</description>
          <population>Analysis was performed on PPAS population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.</population>
          <units>titers (1/dilution)</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="193"/>
                <count group_id="O2" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serogroup A</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1054" lower_limit="825" upper_limit="1346"/>
                    <measurement group_id="O2" value="746" lower_limit="501" upper_limit="1109"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup C</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1559" lower_limit="1140" upper_limit="2131"/>
                    <measurement group_id="O2" value="445" lower_limit="255" upper_limit="776"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup Y</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="591" lower_limit="464" upper_limit="753"/>
                    <measurement group_id="O2" value="260" lower_limit="177" upper_limit="382"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup W 135</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="910" lower_limit="728" upper_limit="1136"/>
                    <measurement group_id="O2" value="493" lower_limit="316" upper_limit="772"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Immediate Unsolicited Adverse Events (AEs) After Vaccination</title>
        <description>An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report form (CRF) in terms of symptom and/or onset post-vaccination. Unsolicited AEs includes both serious and non-serious unsolicited AEs. A serious adverse event (SAE) was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRF.</description>
        <time_frame>Within 30 minutes after vaccination</time_frame>
        <population>Analysis was performed on SafAS population which included participants who received at least one dose of the study or control vaccine and had safety data available.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: MenACYW Conjugate Vaccine</title>
            <description>Adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Menomune® A/C/Y/W 135 Vaccine</title>
            <description>Adult participants aged ≥56 years received a single dose of Menomune® vaccine on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Immediate Unsolicited Adverse Events (AEs) After Vaccination</title>
          <description>An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report form (CRF) in terms of symptom and/or onset post-vaccination. Unsolicited AEs includes both serious and non-serious unsolicited AEs. A serious adverse event (SAE) was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRF.</description>
          <population>Analysis was performed on SafAS population which included participants who received at least one dose of the study or control vaccine and had safety data available.</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="199"/>
                <count group_id="O2" 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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Solicited Injection Site Reactions and Systemic Reactions After Vaccination</title>
        <description>A solicited reaction (SR) was an adverse reaction (AR) observed and reported under the conditions (symptom and onset) prelisted in the CRF. Solicited injection site reactions included: pain, erythema, and swelling. Solicited systemic reactions included: fever, headache, malaise and, myalgia.</description>
        <time_frame>Within 7 days after vaccination</time_frame>
        <population>Analysis was performed on SafAS population. Here, 'Number analyzed' = participants with available data for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: MenACYW Conjugate Vaccine</title>
            <description>Adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Menomune® A/C/Y/W 135 Vaccine</title>
            <description>Adult participants aged ≥56 years received a single dose of Menomune® vaccine on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Solicited Injection Site Reactions and Systemic Reactions After Vaccination</title>
          <description>A solicited reaction (SR) was an adverse reaction (AR) observed and reported under the conditions (symptom and onset) prelisted in the CRF. Solicited injection site reactions included: pain, erythema, and swelling. Solicited systemic reactions included: fever, headache, malaise and, myalgia.</description>
          <population>Analysis was performed on SafAS population. Here, 'Number analyzed' = participants with available data for each specified category.</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="199"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="199"/>
                    <count group_id="O2" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61"/>
                    <measurement group_id="O2" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="199"/>
                    <count group_id="O2" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="198"/>
                    <count group_id="O2" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="2"/>
                  </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="197"/>
                    <count group_id="O2" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="199"/>
                    <count group_id="O2" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47"/>
                    <measurement group_id="O2" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Malaise</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="199"/>
                    <count group_id="O2" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="199"/>
                    <count group_id="O2" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Unsolicited Adverse Events After Vaccination</title>
        <description>An unsolicited AE was an observed AE that does not fulfill the conditions prelisted in the CRF in terms of symptom and/or onset post-vaccination. Unsolicited AEs included both serious and non-serious unsolicited AEs. An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. Non-serious AE (AE excluding SAE) which was significant and prevented daily activity was considered as Grade 3 unsolicited non-serious AE.</description>
        <time_frame>Within 30 days after vaccination</time_frame>
        <population>Analysis was performed on the SafAS population.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: MenACYW Conjugate Vaccine</title>
            <description>Adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Menomune® A/C/Y/W 135 Vaccine</title>
            <description>Adult participants aged ≥56 years received a single dose of Menomune® vaccine on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Unsolicited Adverse Events After Vaccination</title>
          <description>An unsolicited AE was an observed AE that does not fulfill the conditions prelisted in the CRF in terms of symptom and/or onset post-vaccination. Unsolicited AEs included both serious and non-serious unsolicited AEs. An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. Non-serious AE (AE excluding SAE) which was significant and prevented daily activity was considered as Grade 3 unsolicited non-serious AE.</description>
          <population>Analysis was performed on the SafAS population.</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="199"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Unsolicited AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unsolicited non-serious AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 unsolicited non-serious AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Unsolicited AE data were collected from Day 0 up to Day 30 post-vaccination. The SRs were collected within 7 days post-vaccination. SAE information was collected throughout the trial (up to 30 days post-vaccination).</time_frame>
      <desc>A SR was an AE observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the CRF and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.</desc>
      <group_list>
        <group group_id="E1">
          <title>Group 1: MenACYW Conjugate Vaccine</title>
          <description>Adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0.</description>
        </group>
        <group group_id="E2">
          <title>Group 2: Menomune® A/C/Y/W 135 Vaccine</title>
          <description>Adult participants aged ≥56 years received a single dose of Menomune® vaccine on Day 0.</description>
        </group>
      </group_list>
      <serious_events>
        <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="199"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="199"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 15.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="114" subjects_at_risk="199"/>
                <counts group_id="E2" subjects_affected="54" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection Site Erythema</sub_title>
                <counts group_id="E1" events="23" subjects_affected="23" subjects_at_risk="199"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Injection Site Pain</sub_title>
                <counts group_id="E1" events="61" subjects_affected="61" subjects_at_risk="199"/>
                <counts group_id="E2" events="32" subjects_affected="32" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Injection Site Swelling</sub_title>
                <counts group_id="E1" events="15" subjects_affected="15" subjects_at_risk="199"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="44" subjects_affected="44" subjects_at_risk="199"/>
                <counts group_id="E2" events="15" subjects_affected="15" 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="70" subjects_affected="70" subjects_at_risk="199"/>
                <counts group_id="E2" events="26" subjects_affected="26" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <description>1 Headache event which occurred 7 days post-vaccination was considered as an unsolicited AE.</description>
                <counts group_id="E1" events="48" subjects_affected="47" subjects_at_risk="199"/>
                <counts group_id="E2" events="30" subjects_affected="29" 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>The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable participant matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Trial Transparency Team</name_or_title>
      <organization>Sanofi Pasteur</organization>
      <phone>800-633-1610 ext 1#</phone>
      <email>Contact-US@sanofi.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/NCT01732627
org study id: MET44
secondary id: U1111-1127-6804
nct id: NCT01732627
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Primary objectives:

        -  To describe the antibody responses to meningococcal serogroups A, C, Y, and W 135,
           measured by serum bactericidal assay using human complement (hSBA) and baby rabbit
           complement (rSBA), induced by a single dose of Meningococcal Polysaccharide (A, C, Y,
           and W 135) Tetanus Protein (MenACYW) Conjugate vaccine or Menomune® - A/C/Y/W 135.

        -  To describe the safety profile of a single dose of MenACYW Conjugate vaccine or
           Menomune® - A/C/Y/W 135.
All participants received a single dose of their assigned vaccine on Day 0. They were
      assessed for immunogenicity on Day 0 and Day 30, and monitored for safety throughout the
      study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
time frame: Day 0 (pre-vaccination)
description: Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.
measure: Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
time frame: Day 30 (post-vaccination)
description: Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.
measure: Percentage of Participants With Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
time frame: Day 30 (post-vaccination)
description: Vaccine seroresponse for serogroups A, C, Y, and W 135 was measured by hSBA assay method. Seroresponse was defined as post-vaccination hSBA titers ≥1:8 for participants with pre-vaccination hSBA titers less than (<) 1:8, or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers ≥1:8.
measure: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by hSBA Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
time frame: Day 0 (pre-vaccination)
description: GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.
measure: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
time frame: Day 30 (post-vaccination)
description: GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.
measure: Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune®
time frame: Day 0 (pre-vaccination)
description: Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by rSBA assay method.
measure: Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune®
time frame: Day 30 (post-vaccination)
description: Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by rSBA assay method.
measure: Percentage of Participants With Vaccine Seroresponse Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
time frame: Day 30 (post-vaccination)
description: Vaccine seroresponse for serogroups A, C, Y, and W 135 was measured by rSBA assay method. Seroresponse was defined as post-vaccination rSBA titers ≥1:8 for participants with pre-vaccination rSBA titers <1:8, or at least a 4-fold increase in rSBA titers from pre- to post-vaccination for participants with pre-vaccination rSBA titers ≥1:8.
measure: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by rSBA Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
time frame: Day 0 (pre-vaccination)
description: GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 antibody titers were measured by rSBA assay method.
measure: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
time frame: Day 30 (post-vaccination)
description: GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 antibody titers were measured by rSBA assay method.
measure: Number of Participants With Immediate Unsolicited Adverse Events (AEs) After Vaccination
time frame: Within 30 minutes after vaccination
description: An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report form (CRF) in terms of symptom and/or onset post-vaccination. Unsolicited AEs includes both serious and non-serious unsolicited AEs. A serious adverse event (SAE) was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRF.
measure: Number of Participants With Solicited Injection Site Reactions and Systemic Reactions After Vaccination
time frame: Within 7 days after vaccination
description: A solicited reaction (SR) was an adverse reaction (AR) observed and reported under the conditions (symptom and onset) prelisted in the CRF. Solicited injection site reactions included: pain, erythema, and swelling. Solicited systemic reactions included: fever, headache, malaise and, myalgia.
measure: Number of Participants With Unsolicited Adverse Events After Vaccination
time frame: Within 30 days after vaccination
description: An unsolicited AE was an observed AE that does not fulfill the conditions prelisted in the CRF in terms of symptom and/or onset post-vaccination. Unsolicited AEs included both serious and non-serious unsolicited AEs. An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. Non-serious AE (AE excluding SAE) which was significant and prevented daily activity was considered as Grade 3 unsolicited non-serious AE.
arm group label: Group 1: MenACYW Conjugate Vaccine
arm group type: Experimental
description: Adult participants aged greater than or equal to (≥) 56 years received a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W 135) Tetanus Toxoid (MenACYW) Conjugate vaccine on Day 0.
arm group label: Group 2: Menomune® A/C/Y/W 135 vaccine
arm group type: Active Comparator
description: Adult participants aged ≥56 years received a single dose of Meningococcal Polysaccharide Vaccine, Groups A, C, Y, and W 135 Combined (Menomune®) vaccine on Day 0.
intervention type: Biological
intervention name: Meningococcal Polysaccharide (A, C, Y, and W 135) Tetanus Protein Conjugate Vaccine
description: 0.5 milliliter (mL), Intramuscular (IM)
arm group label: Group 1: MenACYW Conjugate Vaccine
other name: MenACYW Conjugate Vaccine
intervention type: Biological
intervention name: Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W 135 Combined
description: 0.5 mL, Subcutaneous (SC)
arm group label: Group 2: Menomune® A/C/Y/W 135 vaccine
other name: Menomune® A/C/Y/W 135
criteria: 
gender: All
minimum age: 56 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Medical Director
role: Study Director
affiliation: Sanofi Pasteur Inc.
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country: United States
citation: Kirstein J, Pina M, Pan J, Jordanov E, Dhingra MS. Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) in adults 56 years of age and older: a Phase II randomized study. Hum Vaccin Immunother. 2020 Jun 2;16(6):1299-1305. doi: 10.1080/21645515.2020.1733868. Epub 2020 Apr 1.
PMID: 32233961
responsible party type: Sponsor
mesh term: Meningococcal Infections
mesh term: Meningitis, Meningococcal
mesh term: Meningitis
mesh term: Vaccines
sharing ipd: Yes
ipd description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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