<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/NCT01725217</url>
  </required_header>
  <id_info>
    <org_study_id>V59_50</org_study_id>
    <nct_id>NCT01725217</nct_id>
  </id_info>
  <brief_title>Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Children, Adolescents and Adults in Russia</brief_title>
  <official_title>A Phase 3, Multi-center, Open-label Study to Evaluate Immunogenicity and Safety of Novartis Meningococcal ACWY Conjugate Vaccine (MenACWY-CRM) in Healthy Children, Adolescents and Adults in Russia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novartis Vaccines</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novartis</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the immune response and safety following a single dose of Novartis Meningococcal&#xD;
      ACWY conjugate vaccine (MenACWY-CRM) in healthy children, adolescents and adults in Russia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentages of Overall Subjects With Seroresponse After MenACWY-CRM Vaccination</measure>
    <time_frame>Day 29</time_frame>
    <description>Immunogenicity was measured as the percentages of overall subjects with hSBA (human serum bactericidal assay) seroresponse, directed against Neisseria meningitidis (N meningitidis) serogroups A, C, W and Y, 28 days after one vaccination of MenACWY-CRM (day 29).&#xD;
The seroresponse is defined as the percentages of subjects achieving hSBA ≥1:8 postvaccination with a prevaccination hSBA &lt;1:4 and the percentages of subjects achieving at least four-fold increases in postvaccination hSBA from day 1 in subjects with a baseline hSBA ≥1:4</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentages of Subjects With Seroresponse After MenACWY-CRM Vaccination, by Age Group</measure>
    <time_frame>Day 29</time_frame>
    <description>Immunogenicity was measured as the percentages of subjects stratified by age group with hSBA response, directed against N meningitidis serogroups A, C, W and Y, 28 days after one vaccination of MenACWY-CRM</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination</measure>
    <time_frame>Days 1 and 29</time_frame>
    <description>Immunogenicity was measured as hSBA GMTs, against N meningitidis serogroups A, C, W and Y, at baseline (day 1) and 28 days after MenACWY-CRM vaccination (day 29), overall and by age group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination</measure>
    <time_frame>Days 1 and 29</time_frame>
    <description>Immunogenicity was measured as the percentages of subjects with hSBA titer ≥1:8, at baseline (day 1) and 28 days after MenACWY-CRM vaccination (day 29), overall and by age group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentages of Subjects Aged 2 Through 5 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination</measure>
    <time_frame>Within days 1 through 7 postvaccination</time_frame>
    <description>Safety was assessed as the percentages of subjects aged 2 through 5 years who reported solicited local and systemic AEs within days 1 through 7 after MenACWY-CRM vaccination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination</measure>
    <time_frame>Within days 1 through 7 postvaccination</time_frame>
    <description>Safety was assessed as the percentages of subjects aged ≥6 years who reported solicited local and systemic AEs within days 1 through 7 after MenACWY-CRM vaccination, overall and by age group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentages of Subjects Reporting Unsolicited Adverse Events (AEs) After MenACWY-CRM Vaccination</measure>
    <time_frame>AEs occurring from day 1 through 7, medically attended AEs, SAEs and AEs resulting in premature withdrawal, from day 1 through 29</time_frame>
    <description>Safety was assessed in terms of percentages of subjects who reported all the adverse events (AEs) occurring from day 1 through 7, medically attended AEs, SAEs and AEs resulting in premature withdrawal, from day 1 through 29, after MenACWY-CRM vaccination, overall and by age group</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">198</enrollment>
  <condition>Meningococcal Disease</condition>
  <arm_group>
    <arm_group_label>MenACWY-CRM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MenACWY-CRM</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>MenACWY-CRM</intervention_name>
    <description>1 vaccination at visit 1, conjugate vaccine, Intramuscular (IM) injection</description>
    <arm_group_label>MenACWY-CRM</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Individuals eligible for enrollment in this study were those:&#xD;
&#xD;
          1. Who were of any gender, from the age of 2 years and above at the time of visit 1, and&#xD;
             to whom the nature of the study had been described and:&#xD;
&#xD;
               -  the parent/legal representative had provided written informed consent (≥2 to &lt;18&#xD;
                  years of age),&#xD;
&#xD;
               -  had provided written assent (≥11 to &lt;18 years of age),&#xD;
&#xD;
               -  had provided written informed consent (≥18 years of age onwards).&#xD;
&#xD;
          2. Who the investigator believed that the subject and/or his or her parent/legal&#xD;
             representative could and would comply with the requirements of the protocol (e.g.,&#xD;
             completion of the Diary Card, return for follow-up visit).&#xD;
&#xD;
          3. Who were in good health as determined by&#xD;
&#xD;
               -  medical history&#xD;
&#xD;
               -  physical exam&#xD;
&#xD;
               -  clinical judgment of the investigator&#xD;
&#xD;
          4. Who had a negative urine pregnancy test for female subjects from 11 years of age.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Individuals not eligible to be enrolled in the study were those:&#xD;
&#xD;
          1. Who were unwilling or unable to give written informed assent or consent to participate&#xD;
             in the study.&#xD;
&#xD;
          2. Who were perceived to be unreliable or unavailable for the duration of the study&#xD;
             period.&#xD;
&#xD;
          3. Who had a previous confirmed or suspected disease caused by N meningitidis.&#xD;
&#xD;
          4. Who had household contact with and/or intimate exposure to an individual with&#xD;
             culture-proven N meningitidis infection within 60 days prior to enrollment.&#xD;
&#xD;
          5. Who had previously been immunized with a meningococcal vaccine or vaccine containing&#xD;
             meningococcal antigen(s) (licensed or investigational).&#xD;
&#xD;
          6. Who were pregnant or breast feeding (female subjects).&#xD;
&#xD;
          7. Who had received any investigational or non-registered product (drug or vaccine)&#xD;
             within 28 days prior to enrollment or who expected to receive an investigational drug&#xD;
             or vaccine prior to the completion of the study.&#xD;
&#xD;
          8. Who had received any vaccines within 14 days (for inactivated vaccines) or 28 days&#xD;
             (for live vaccines) prior to enrollment in this study or who were planning to receive&#xD;
             any vaccine within 30 days from the study vaccines.&#xD;
&#xD;
             (Exception: Influenza vaccine might be administered up to 15 days prior to study&#xD;
             vaccination and at least 15 days after study vaccination).&#xD;
&#xD;
          9. Who had experienced within the 7 days prior to enrollment significant acute infection&#xD;
             (for example requiring systemic antibiotic treatment or antiviral therapy) or had&#xD;
             experienced fever (defined as body temperature ≥ 38°C) within 3 days prior to&#xD;
             enrollment.&#xD;
&#xD;
         10. Who had any serious acute, chronic or progressive disease (e.g., any history of&#xD;
             neoplasm, cancer, diabetes, cardiac disease, autoimmune disease, Human&#xD;
             immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS),&#xD;
             or blood dyscrasias, with signs of cardiac or renal failure or severe malnutrition).&#xD;
             Who had epilepsy or any progressive neurological disease or history of Guillain-Barre&#xD;
             syndrome.&#xD;
&#xD;
         11. Who had a history of any anaphylaxis, serious vaccine reactions, or allergy to any&#xD;
             vaccine components including diphtheria toxin (CRM-197) and latex in the syringe.&#xD;
&#xD;
         12. Who had a known or suspected impairment/alteration of immune function, either&#xD;
             congenital or acquired or resulting from (for example):&#xD;
&#xD;
               -  receipt of immunosuppressive therapy within 30 days prior to enrollment (any&#xD;
                  systemic corticosteroid administered for more than 5 days, or in a daily dose &gt; 1&#xD;
                  mg/kg/day prednisone or equivalent during any of 30 days prior to enrollment, or&#xD;
                  cancer chemotherapy)&#xD;
&#xD;
               -  receipt of immunostimulants&#xD;
&#xD;
               -  receipt of parenteral immunoglobulin preparation, blood products, and/or plasma&#xD;
                  derivatives within 90 days prior to enrollment and for the full length of the&#xD;
                  study&#xD;
&#xD;
         13. Who were known to have a bleeding diathesis, or any condition that may be associated&#xD;
             with a prolonged bleeding time.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Novartis Vaccines and Diagnostics</last_name>
    <role>Study Chair</role>
    <affiliation>Novartis Vaccines</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Federal State Budgetary Institution 'State Scientific Center 'Institution of Immunology' of the Russian Federal Biomedical Agency'</name>
      <address>
        <city>Kashirskoye Highway</city>
        <state>Moscow</state>
        <zip>115478</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institution of the Russian Academy of Sciences &quot;Scientific Center for Children Health RAMS&quot;</name>
      <address>
        <city>Lomonosovskiy Avenue</city>
        <state>Moscow</state>
        <zip>119991</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Federal Budgetary Institution of Science 'St-Petersburg Scientific-Research Institution of Epidemiology and Microbiology by name of Pasteur'</name>
      <address>
        <city>Mira Street</city>
        <state>St-Petersburg</state>
        <zip>197101</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Federal State Institution 'Scientific-Research Institution of Children's Infections of the Russian Federal Biomedical Agency'</name>
      <address>
        <city>Prof.Popova Street</city>
        <state>St-Petersburg</state>
        <zip>197022</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <reference>
    <citation>Trotter CL, Andrews NJ, Kaczmarski EB, Miller E, Ramsay ME. Effectiveness of meningococcal serogroup C conjugate vaccine 4 years after introduction. Lancet. 2004 Jul 24-30;364(9431):365-7. doi: 10.1016/S0140-6736(04)16725-1.</citation>
    <PMID>15276396</PMID>
  </reference>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>November 8, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 12, 2012</study_first_posted>
  <results_first_submitted>February 3, 2014</results_first_submitted>
  <results_first_submitted_qc>February 3, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">March 18, 2014</results_first_posted>
  <last_update_submitted>April 27, 2023</last_update_submitted>
  <last_update_submitted_qc>April 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Meningitis</keyword>
  <keyword>children</keyword>
  <keyword>adolescents</keyword>
  <keyword>adults</keyword>
  <keyword>MenACWY</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Meningococcal Infections</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were enrolled at 5 centers in Russia</recruitment_details>
      <pre_assignment_details>All enrolled subjects were included in the study</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>≥2 to ≤10 Years</title>
          <description>Subjects ≥2 to ≤10 years of age who received one vaccination of MenACWY-CRM</description>
        </group>
        <group group_id="P2">
          <title>≥11 to ≤17 Years</title>
          <description>Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM</description>
        </group>
        <group group_id="P3">
          <title>≥18 Years</title>
          <description>Subjects ≥18 years of age who received one vaccination of MenACWY-CRM</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="66"/>
                <participants group_id="P2" count="66"/>
                <participants group_id="P3" count="66"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="65"/>
                <participants group_id="P2" count="66"/>
                <participants group_id="P3" count="66"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_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 group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>≥2 to ≤10 Years</title>
          <description>Subjects ≥2 to ≤10 years of age who received one vaccination of MenACWY-CRM</description>
        </group>
        <group group_id="B2">
          <title>≥11 to ≤17 Years</title>
          <description>Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM</description>
        </group>
        <group group_id="B3">
          <title>≥18 Years</title>
          <description>Subjects ≥18 years of age who received one vaccination of MenACWY-CRM</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="66"/>
            <count group_id="B2" value="66"/>
            <count group_id="B3" value="66"/>
            <count group_id="B4" value="198"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>year</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.0" spread="2.7"/>
                    <measurement group_id="B2" value="13.8" spread="2.1"/>
                    <measurement group_id="B3" value="38.8" spread="12.5"/>
                    <measurement group_id="B4" value="19.6" spread="15.9"/>
                  </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="35"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="44"/>
                    <measurement group_id="B4" value="108"/>
                  </measurement_list>
                </category>
                <category>
                  <title>MALE</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="22"/>
                    <measurement group_id="B4" value="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentages of Overall Subjects With Seroresponse After MenACWY-CRM Vaccination</title>
        <description>Immunogenicity was measured as the percentages of overall subjects with hSBA (human serum bactericidal assay) seroresponse, directed against Neisseria meningitidis (N meningitidis) serogroups A, C, W and Y, 28 days after one vaccination of MenACWY-CRM (day 29).&#xD;
The seroresponse is defined as the percentages of subjects achieving hSBA ≥1:8 postvaccination with a prevaccination hSBA &lt;1:4 and the percentages of subjects achieving at least four-fold increases in postvaccination hSBA from day 1 in subjects with a baseline hSBA ≥1:4</description>
        <time_frame>Day 29</time_frame>
        <population>Analysis was done on Full Analysis Set (FAS), i.e., all subjects in the exposed population who provided one evaluable serum sample whose assay result is available for at least one serogroup at baseline and at day 29</population>
        <group_list>
          <group group_id="O1">
            <title>Overall (≥2 Years)</title>
            <description>All subjects ≥2 years of age who received one vaccination of MenACWY-CRM</description>
          </group>
        </group_list>
        <measure>
          <title>Percentages of Overall Subjects With Seroresponse After MenACWY-CRM Vaccination</title>
          <description>Immunogenicity was measured as the percentages of overall subjects with hSBA (human serum bactericidal assay) seroresponse, directed against Neisseria meningitidis (N meningitidis) serogroups A, C, W and Y, 28 days after one vaccination of MenACWY-CRM (day 29).&#xD;
The seroresponse is defined as the percentages of subjects achieving hSBA ≥1:8 postvaccination with a prevaccination hSBA &lt;1:4 and the percentages of subjects achieving at least four-fold increases in postvaccination hSBA from day 1 in subjects with a baseline hSBA ≥1:4</description>
          <population>Analysis was done on Full Analysis Set (FAS), i.e., all subjects in the exposed population who provided one evaluable serum sample whose assay result is available for at least one serogroup at baseline and at day 29</population>
          <units>Percentage of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="193"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>MenA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85" lower_limit="79" upper_limit="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MenC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74" lower_limit="67" upper_limit="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MenW</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60" lower_limit="53" upper_limit="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MenY</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83" lower_limit="77" upper_limit="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentages of Subjects With Seroresponse After MenACWY-CRM Vaccination, by Age Group</title>
        <description>Immunogenicity was measured as the percentages of subjects stratified by age group with hSBA response, directed against N meningitidis serogroups A, C, W and Y, 28 days after one vaccination of MenACWY-CRM</description>
        <time_frame>Day 29</time_frame>
        <population>Analysis was done on FAS dataset</population>
        <group_list>
          <group group_id="O1">
            <title>≥2 to ≤10 Years</title>
            <description>Subjects ≥2 to ≤10 years of age who received one vaccination of MenACWY-CRM</description>
          </group>
          <group group_id="O2">
            <title>≥11 to ≤17 Years</title>
            <description>Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM</description>
          </group>
          <group group_id="O3">
            <title>≥18 Years</title>
            <description>Subjects ≥18 years of age who received one vaccination of MenACWY-CRM</description>
          </group>
        </group_list>
        <measure>
          <title>Percentages of Subjects With Seroresponse After MenACWY-CRM Vaccination, by Age Group</title>
          <description>Immunogenicity was measured as the percentages of subjects stratified by age group with hSBA response, directed against N meningitidis serogroups A, C, W and Y, 28 days after one vaccination of MenACWY-CRM</description>
          <population>Analysis was done on FAS dataset</population>
          <units>Percentage of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="65"/>
                <count group_id="O3" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>MenA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89" lower_limit="78" upper_limit="95"/>
                    <measurement group_id="O2" value="89" lower_limit="79" upper_limit="96"/>
                    <measurement group_id="O3" value="77" lower_limit="65" upper_limit="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MenC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69" lower_limit="56" upper_limit="80"/>
                    <measurement group_id="O2" value="82" lower_limit="70" upper_limit="90"/>
                    <measurement group_id="O3" value="71" lower_limit="58" upper_limit="81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MenW</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73" lower_limit="60" upper_limit="83"/>
                    <measurement group_id="O2" value="51" lower_limit="38" upper_limit="63"/>
                    <measurement group_id="O3" value="57" lower_limit="44" upper_limit="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MenY</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77" lower_limit="65" upper_limit="87"/>
                    <measurement group_id="O2" value="88" lower_limit="77" upper_limit="95"/>
                    <measurement group_id="O3" value="85" lower_limit="74" upper_limit="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination</title>
        <description>Immunogenicity was measured as hSBA GMTs, against N meningitidis serogroups A, C, W and Y, at baseline (day 1) and 28 days after MenACWY-CRM vaccination (day 29), overall and by age group</description>
        <time_frame>Days 1 and 29</time_frame>
        <population>Analysis was done on FAS dataset</population>
        <group_list>
          <group group_id="O1">
            <title>Overall (≥2 Years)</title>
            <description>All subjects ≥2 years of age who received one vaccination of MenACWY-CRM</description>
          </group>
          <group group_id="O2">
            <title>≥2 to ≤10 Years</title>
            <description>Subjects ≥2 to ≤10 years of age who received one vaccination of MenACWY-CRM</description>
          </group>
          <group group_id="O3">
            <title>≥11 to ≤17 Years</title>
            <description>Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM</description>
          </group>
          <group group_id="O4">
            <title>≥18 Years</title>
            <description>Subjects ≥18 years of age who received one vaccination of MenACWY-CRM</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination</title>
          <description>Immunogenicity was measured as hSBA GMTs, against N meningitidis serogroups A, C, W and Y, at baseline (day 1) and 28 days after MenACWY-CRM vaccination (day 29), overall and by age group</description>
          <population>Analysis was done on FAS dataset</population>
          <units>human serum bactericidal assay titer</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="193"/>
                <count group_id="O2" value="63"/>
                <count group_id="O3" value="65"/>
                <count group_id="O4" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>MenA (Day 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.35" lower_limit="2.17" upper_limit="2.55"/>
                    <measurement group_id="O2" value="2.17" lower_limit="1.79" upper_limit="2.62"/>
                    <measurement group_id="O3" value="2.43" lower_limit="2.01" upper_limit="2.93"/>
                    <measurement group_id="O4" value="2.61" lower_limit="2.11" upper_limit="3.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MenA (Day 29)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93" lower_limit="73" upper_limit="119"/>
                    <measurement group_id="O2" value="67" lower_limit="38" upper_limit="119"/>
                    <measurement group_id="O3" value="134" lower_limit="77" upper_limit="233"/>
                    <measurement group_id="O4" value="76" lower_limit="41" upper_limit="143"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MenC (Day 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.07" lower_limit="3.45" upper_limit="4.8"/>
                    <measurement group_id="O2" value="3.16" lower_limit="2.18" upper_limit="4.57"/>
                    <measurement group_id="O3" value="3.59" lower_limit="2.5" upper_limit="5.15"/>
                    <measurement group_id="O4" value="6.68" lower_limit="4.43" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MenC (Day 29)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59" lower_limit="43" upper_limit="81"/>
                    <measurement group_id="O2" value="28" lower_limit="14" upper_limit="56"/>
                    <measurement group_id="O3" value="47" lower_limit="24" upper_limit="92"/>
                    <measurement group_id="O4" value="112" lower_limit="52" upper_limit="243"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MenW (Day 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12" lower_limit="9.42" upper_limit="15"/>
                    <measurement group_id="O2" value="7.93" lower_limit="4.69" upper_limit="13"/>
                    <measurement group_id="O3" value="21" lower_limit="13" upper_limit="36"/>
                    <measurement group_id="O4" value="13" lower_limit="7.16" upper_limit="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MenW (Day 29)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="111" lower_limit="89" upper_limit="139"/>
                    <measurement group_id="O2" value="94" lower_limit="56" upper_limit="155"/>
                    <measurement group_id="O3" value="117" lower_limit="72" upper_limit="191"/>
                    <measurement group_id="O4" value="143" lower_limit="83" upper_limit="248"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MenY (Day 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.93" lower_limit="2.61" upper_limit="3.28"/>
                    <measurement group_id="O2" value="3.02" lower_limit="2.33" upper_limit="3.92"/>
                    <measurement group_id="O3" value="3.73" lower_limit="2.89" upper_limit="4.82"/>
                    <measurement group_id="O4" value="2.74" lower_limit="2.05" upper_limit="3.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MenY (Day 29)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58" lower_limit="46" upper_limit="74"/>
                    <measurement group_id="O2" value="32" lower_limit="18" upper_limit="56"/>
                    <measurement group_id="O3" value="67" lower_limit="39" upper_limit="115"/>
                    <measurement group_id="O4" value="80" lower_limit="43" upper_limit="147"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination</title>
        <description>Immunogenicity was measured as the percentages of subjects with hSBA titer ≥1:8, at baseline (day 1) and 28 days after MenACWY-CRM vaccination (day 29), overall and by age group</description>
        <time_frame>Days 1 and 29</time_frame>
        <population>Analysis was done on FAS dataset</population>
        <group_list>
          <group group_id="O1">
            <title>Overall (≥2 Years)</title>
            <description>All subjects ≥2 years of age who received one vaccination of MenACWY-CRM</description>
          </group>
          <group group_id="O2">
            <title>≥2 to ≤10 Years</title>
            <description>Subjects ≥2 to ≤10 years of age who received one vaccination of MenACWY-CRM</description>
          </group>
          <group group_id="O3">
            <title>≥11 to ≤17 Years</title>
            <description>Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM</description>
          </group>
          <group group_id="O4">
            <title>≥18 Years</title>
            <description>Subjects ≥18 years of age who received one vaccination of MenACWY-CRM</description>
          </group>
        </group_list>
        <measure>
          <title>Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination</title>
          <description>Immunogenicity was measured as the percentages of subjects with hSBA titer ≥1:8, at baseline (day 1) and 28 days after MenACWY-CRM vaccination (day 29), overall and by age group</description>
          <population>Analysis was done on FAS dataset</population>
          <units>Percentage of Subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="193"/>
                <count group_id="O2" value="63"/>
                <count group_id="O3" value="65"/>
                <count group_id="O4" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>MenA (Day 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6" lower_limit="3" upper_limit="10"/>
                    <measurement group_id="O2" value="2" lower_limit="0.04" upper_limit="9"/>
                    <measurement group_id="O3" value="5" lower_limit="1" upper_limit="13"/>
                    <measurement group_id="O4" value="11" lower_limit="4" upper_limit="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MenA (Day 29)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89" lower_limit="83" upper_limit="93"/>
                    <measurement group_id="O2" value="89" lower_limit="78" upper_limit="95"/>
                    <measurement group_id="O3" value="92" lower_limit="83" upper_limit="97"/>
                    <measurement group_id="O4" value="85" lower_limit="74" upper_limit="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MenC (Day 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26" lower_limit="20" upper_limit="33"/>
                    <measurement group_id="O2" value="13" lower_limit="6" upper_limit="23"/>
                    <measurement group_id="O3" value="17" lower_limit="9" upper_limit="28"/>
                    <measurement group_id="O4" value="49" lower_limit="37" upper_limit="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MenC (Day 29)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84" lower_limit="78" upper_limit="89"/>
                    <measurement group_id="O2" value="76" lower_limit="63" upper_limit="86"/>
                    <measurement group_id="O3" value="86" lower_limit="75" upper_limit="93"/>
                    <measurement group_id="O4" value="89" lower_limit="79" upper_limit="96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MenW (Day 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57" lower_limit="50" upper_limit="64"/>
                    <measurement group_id="O2" value="30" lower_limit="19" upper_limit="43"/>
                    <measurement group_id="O3" value="71" lower_limit="58" upper_limit="81"/>
                    <measurement group_id="O4" value="69" lower_limit="57" upper_limit="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MenW (Day 29)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97" lower_limit="93" upper_limit="99"/>
                    <measurement group_id="O2" value="95" lower_limit="87" upper_limit="99"/>
                    <measurement group_id="O3" value="98" lower_limit="92" upper_limit="100"/>
                    <measurement group_id="O4" value="97" lower_limit="89" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MenY (Day 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16" lower_limit="11" upper_limit="22"/>
                    <measurement group_id="O2" value="10" lower_limit="4" upper_limit="20"/>
                    <measurement group_id="O3" value="15" lower_limit="8" upper_limit="26"/>
                    <measurement group_id="O4" value="22" lower_limit="12" upper_limit="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MenY (Day 29)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88" lower_limit="82" upper_limit="92"/>
                    <measurement group_id="O2" value="79" lower_limit="67" upper_limit="88"/>
                    <measurement group_id="O3" value="94" lower_limit="85" upper_limit="98"/>
                    <measurement group_id="O4" value="89" lower_limit="79" upper_limit="96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentages of Subjects Aged 2 Through 5 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination</title>
        <description>Safety was assessed as the percentages of subjects aged 2 through 5 years who reported solicited local and systemic AEs within days 1 through 7 after MenACWY-CRM vaccination</description>
        <time_frame>Within days 1 through 7 postvaccination</time_frame>
        <population>Analysis was done on safety dataset, i.e. all subjects in the exposed population who provided any post-baseline safety data</population>
        <group_list>
          <group group_id="O1">
            <title>≥2 to ≤5 Years</title>
            <description>Subjects ≥2 to ≤5 years of age who received one vaccination of MenACWY-CRM</description>
          </group>
          <group group_id="O2">
            <title>≥2 to ≤3 Years</title>
            <description>Subjects ≥2 to ≤3 years of age who received one vaccination of MenACWY-CRM</description>
          </group>
        </group_list>
        <measure>
          <title>Percentages of Subjects Aged 2 Through 5 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination</title>
          <description>Safety was assessed as the percentages of subjects aged 2 through 5 years who reported solicited local and systemic AEs within days 1 through 7 after MenACWY-CRM vaccination</description>
          <population>Analysis was done on safety dataset, i.e. all subjects in the exposed population who provided any post-baseline safety data</population>
          <units>Percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Tenderness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                    <measurement group_id="O2" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Induration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change in Eating Habits</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sleepiness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O2" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Irritability</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vomiting</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diarrhea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rash</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever (≥38 °C)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Use of analgesics/antipyretics</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination</title>
        <description>Safety was assessed as the percentages of subjects aged ≥6 years who reported solicited local and systemic AEs within days 1 through 7 after MenACWY-CRM vaccination, overall and by age group</description>
        <time_frame>Within days 1 through 7 postvaccination</time_frame>
        <population>Analysis was done on safety dataset</population>
        <group_list>
          <group group_id="O1">
            <title>Overall (≥6 Years)</title>
            <description>All subjects ≥6 years of age who received one vaccination of MenACWY-CRM</description>
          </group>
          <group group_id="O2">
            <title>≥6 to ≤10 Years</title>
            <description>Subjects ≥6 to ≤10 years of age who received one vaccination of MenACWY-CRM</description>
          </group>
          <group group_id="O3">
            <title>≥11 to ≤17 Years</title>
            <description>Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM</description>
          </group>
          <group group_id="O4">
            <title>≥18 Years</title>
            <description>Subjects ≥18 years of age who received one vaccination of MenACWY-CRM</description>
          </group>
        </group_list>
        <measure>
          <title>Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination</title>
          <description>Safety was assessed as the percentages of subjects aged ≥6 years who reported solicited local and systemic AEs within days 1 through 7 after MenACWY-CRM vaccination, overall and by age group</description>
          <population>Analysis was done on safety dataset</population>
          <units>Percentage of Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="170"/>
                <count group_id="O2" value="38"/>
                <count group_id="O3" value="66"/>
                <count group_id="O4" value="66"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                    <measurement group_id="O2" value="42"/>
                    <measurement group_id="O3" value="50"/>
                    <measurement group_id="O4" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="18"/>
                    <measurement group_id="O3" value="18"/>
                    <measurement group_id="O4" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Induration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="17"/>
                    <measurement group_id="O4" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chills</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nausea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Malaise</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="16"/>
                    <measurement group_id="O3" value="23"/>
                    <measurement group_id="O4" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="29"/>
                    <measurement group_id="O4" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Arthralgia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="18"/>
                    <measurement group_id="O3" value="27"/>
                    <measurement group_id="O4" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rash</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever (≥38 °C)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Use of analgesic/antipyretics</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="18"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentages of Subjects Reporting Unsolicited Adverse Events (AEs) After MenACWY-CRM Vaccination</title>
        <description>Safety was assessed in terms of percentages of subjects who reported all the adverse events (AEs) occurring from day 1 through 7, medically attended AEs, SAEs and AEs resulting in premature withdrawal, from day 1 through 29, after MenACWY-CRM vaccination, overall and by age group</description>
        <time_frame>AEs occurring from day 1 through 7, medically attended AEs, SAEs and AEs resulting in premature withdrawal, from day 1 through 29</time_frame>
        <population>Analysis was done on safety dataset</population>
        <group_list>
          <group group_id="O1">
            <title>Overall (≥2 Years)</title>
            <description>All subjects ≥2 years of age who received one vaccination of MenACWY-CRM</description>
          </group>
          <group group_id="O2">
            <title>≥2 to ≤10 Years</title>
            <description>Subjects ≥2 to ≤10 years of age who received one vaccination of MenACWY-CRM</description>
          </group>
          <group group_id="O3">
            <title>≥11 to ≤17 Years</title>
            <description>Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM</description>
          </group>
          <group group_id="O4">
            <title>≥18 Years</title>
            <description>Subjects ≥18 years of age who received one vaccination of MenACWY-CRM</description>
          </group>
        </group_list>
        <measure>
          <title>Percentages of Subjects Reporting Unsolicited Adverse Events (AEs) After MenACWY-CRM Vaccination</title>
          <description>Safety was assessed in terms of percentages of subjects who reported all the adverse events (AEs) occurring from day 1 through 7, medically attended AEs, SAEs and AEs resulting in premature withdrawal, from day 1 through 29, after MenACWY-CRM vaccination, overall and by age group</description>
          <population>Analysis was done on safety dataset</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="197"/>
                <count group_id="O2" value="65"/>
                <count group_id="O3" value="66"/>
                <count group_id="O4" value="66"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any AEs(days 1 through 7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="20"/>
                    <measurement group_id="O3" value="12"/>
                    <measurement group_id="O4" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least possibly related AEs (days 1 through 7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAE(days 1 through 29)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least possibly related SAE(days 1 through 29)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Medically attended AE(days 1 through 29)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Premature withdrawal due to AE(days 1 through 29)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From day 1 through day 29</time_frame>
      <desc>Serious adverse events (SAEs) were collected from day 1 through day 29</desc>
      <group_list>
        <group group_id="E1">
          <title>≥2 to ≤10 Years</title>
          <description>Subjects ≥2 to ≤10 years of age who received one vaccination of MenACWY-CRM</description>
        </group>
        <group group_id="E2">
          <title>≥11 to ≤17 Years</title>
          <description>Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM</description>
        </group>
        <group group_id="E3">
          <title>≥18 Years</title>
          <description>Subjects ≥18 years of age who received one vaccination of MenACWY-CRM</description>
        </group>
        <group group_id="E4">
          <title>Overall (≥2 Years)</title>
          <description>All subjects ≥2 years of age who received one vaccination of MenACWY-CRM</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="65"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA v15.0</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="42" subjects_at_risk="65"/>
                <counts group_id="E2" subjects_affected="42" subjects_at_risk="66"/>
                <counts group_id="E3" subjects_affected="44" subjects_at_risk="66"/>
                <counts group_id="E4" subjects_affected="128" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="66"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="66"/>
                <counts group_id="E4" subjects_affected="13" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="65"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="66"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="66"/>
                <counts group_id="E4" subjects_affected="16" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="65"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="66"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="66"/>
                <counts group_id="E4" subjects_affected="35" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Injection site induration</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="65"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="66"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="66"/>
                <counts group_id="E4" subjects_affected="27" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="65"/>
                <counts group_id="E2" subjects_affected="33" subjects_at_risk="66"/>
                <counts group_id="E3" subjects_affected="33" subjects_at_risk="66"/>
                <counts group_id="E4" subjects_affected="93" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="65"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="65"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="66"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="66"/>
                <counts group_id="E4" subjects_affected="34" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Rhinitis</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="65"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="65"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="66"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="66"/>
                <counts group_id="E4" subjects_affected="15" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="65"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="66"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="66"/>
                <counts group_id="E4" subjects_affected="33" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="65"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="66"/>
                <counts group_id="E3" subjects_affected="18" subjects_at_risk="66"/>
                <counts group_id="E4" subjects_affected="44" subjects_at_risk="197"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="65"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="66"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="197"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Posting Director</name_or_title>
      <organization>Novartis Vaccines and Diagnostics</organization>
      <email>RegistryContactVaccinesUS@novartis.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/NCT01725217
org study id: V59_50
nct id: NCT01725217
lead sponsor: 
has dmc: No
To evaluate the immune response and safety following a single dose of Novartis Meningococcal
      ACWY conjugate vaccine (MenACWY-CRM) in healthy children, adolescents and adults in Russia.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Percentages of Overall Subjects With Seroresponse After MenACWY-CRM Vaccination
time frame: Day 29
description: Immunogenicity was measured as the percentages of overall subjects with hSBA (human serum bactericidal assay) seroresponse, directed against Neisseria meningitidis (N meningitidis) serogroups A, C, W and Y, 28 days after one vaccination of MenACWY-CRM (day 29).
The seroresponse is defined as the percentages of subjects achieving hSBA ≥1:8 postvaccination with a prevaccination hSBA <1:4 and the percentages of subjects achieving at least four-fold increases in postvaccination hSBA from day 1 in subjects with a baseline hSBA ≥1:4
measure: Percentages of Subjects With Seroresponse After MenACWY-CRM Vaccination, by Age Group
time frame: Day 29
description: Immunogenicity was measured as the percentages of subjects stratified by age group with hSBA response, directed against N meningitidis serogroups A, C, W and Y, 28 days after one vaccination of MenACWY-CRM
measure: Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination
time frame: Days 1 and 29
description: Immunogenicity was measured as hSBA GMTs, against N meningitidis serogroups A, C, W and Y, at baseline (day 1) and 28 days after MenACWY-CRM vaccination (day 29), overall and by age group
measure: Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination
time frame: Days 1 and 29
description: Immunogenicity was measured as the percentages of subjects with hSBA titer ≥1:8, at baseline (day 1) and 28 days after MenACWY-CRM vaccination (day 29), overall and by age group
measure: Percentages of Subjects Aged 2 Through 5 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination
time frame: Within days 1 through 7 postvaccination
description: Safety was assessed as the percentages of subjects aged 2 through 5 years who reported solicited local and systemic AEs within days 1 through 7 after MenACWY-CRM vaccination
measure: Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination
time frame: Within days 1 through 7 postvaccination
description: Safety was assessed as the percentages of subjects aged ≥6 years who reported solicited local and systemic AEs within days 1 through 7 after MenACWY-CRM vaccination, overall and by age group
measure: Percentages of Subjects Reporting Unsolicited Adverse Events (AEs) After MenACWY-CRM Vaccination
time frame: AEs occurring from day 1 through 7, medically attended AEs, SAEs and AEs resulting in premature withdrawal, from day 1 through 29
description: Safety was assessed in terms of percentages of subjects who reported all the adverse events (AEs) occurring from day 1 through 7, medically attended AEs, SAEs and AEs resulting in premature withdrawal, from day 1 through 29, after MenACWY-CRM vaccination, overall and by age group
arm group label: MenACWY-CRM
arm group type: Experimental
description: MenACWY-CRM
intervention type: Biological
intervention name: MenACWY-CRM
description: 1 vaccination at visit 1, conjugate vaccine, Intramuscular (IM) injection
arm group label: MenACWY-CRM
criteria: 
gender: All
minimum age: 2 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Novartis Vaccines and Diagnostics
role: Study Chair
affiliation: Novartis Vaccines
facility: 
facility: 
facility: 
facility: 
country: Russian Federation
citation: Trotter CL, Andrews NJ, Kaczmarski EB, Miller E, Ramsay ME. Effectiveness of meningococcal serogroup C conjugate vaccine 4 years after introduction. Lancet. 2004 Jul 24-30;364(9431):365-7. doi: 10.1016/S0140-6736(04)16725-1.
PMID: 15276396
responsible party type: Sponsor
mesh term: Meningococcal Infections
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 