<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/NCT03295318</url>
  </required_header>
  <id_info>
    <org_study_id>ACYWX-002</org_study_id>
    <secondary_id>CVIA-058</secondary_id>
    <nct_id>NCT03295318</nct_id>
  </id_info>
  <brief_title>Clinical Study of Meningococcal ACYWX Conjugate Vaccine, in 12-16 Month Olds</brief_title>
  <official_title>A Phase 2, Observer-blind, Randomized, Controlled Study to Evaluate the Safety and Immunogenicity of Two Formulations of Investigational Meningococcal Groups ACYWX Conjugate Vaccine, Administered to Healthy Malian Children 12-16 Months of Age</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Serum Institute of India Pvt. Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>PATH</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Serum Institute of India Pvt. Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Out of the 13 identified serogroups of Neisseria meningitidis (Nm) the six serogroups (A, B,&#xD;
      C, W, Y and X) are responsible for majority of infections. Presently available vaccines&#xD;
      effectively protect against A, B, C, W and Y serogroups; but no vaccine that is protective&#xD;
      against serogroup X is available yet.&#xD;
&#xD;
      Serum Institute of India Private Limited (SIIPL) has developed a conjugate vaccine against&#xD;
      serogroups A, C, Y, W and X (NmCV-5).&#xD;
&#xD;
      The first-in-human Phase 1 study was among 60 healthy adults in USA did not show no any&#xD;
      safety issues.&#xD;
&#xD;
      This phase 2 study is designed to evaluate safety and immunogenicity of the non-adjuvanted&#xD;
      and adjuvanted formulations of NmCV-5 in healthy children 12-16 months of age, in comparison&#xD;
      with the licensed quadrivalent meningococcal conjugate vaccine (Menactra®).&#xD;
&#xD;
      Both vaccines will be administered in two dose schedule 3 months apart. among vaccine-naïve&#xD;
      healthy subjects in Mali. Safety will be assessed by collecting solicited reactions till day&#xD;
      7 post each dose whereas adverse events will be collected throughout the study. Each subject&#xD;
      will be followed up for 84 days post each vaccine dose.&#xD;
&#xD;
      The vaccine immunogenicity will measured using a rabbit complement serum bactericidal&#xD;
      activity assay (rSBA).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 15, 2017</start_date>
  <completion_date type="Actual">August 31, 2018</completion_date>
  <primary_completion_date type="Actual">August 31, 2018</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Observer blind wherein the pharmacist and other study staff involved in vaccine administration will be aware of the treatment allocation.&#xD;
The other study staff involved in safety assessments will be masked to treatment arm. The laboratory involved in immunogenicity analysis will also be blinded to the treatment allocation.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Severe Solicited Adverse Event</measure>
    <time_frame>7 days post each vaccination</time_frame>
    <description>Percentage of subjects with at least one severe solicited AE within 7 days after any study vaccination (Days 0-6 and Days 84-90)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Seroprotective rSBA Titres</measure>
    <time_frame>112 days</time_frame>
    <description>Percentage of subjects with rSBA titer ≥ 8 against serogroups A, C, W, Y and X at Visits Day 0 (Baseline), Day 28 (28 days after dose 1), Day 84 (prior to dose 2) and Day 112 (28 days after dose 2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Long Term Protective rSBA Titres</measure>
    <time_frame>112 days</time_frame>
    <description>Percentage of subjects with rSBA titer ≥ 128 against serogroups A, C, W, Y and X at Visits Day 0, Day 28, Day 84 and Day 112</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rise in rSBA Titres</measure>
    <time_frame>112 days</time_frame>
    <description>Percentage of subjects with fourfold rise in rSBA titers against serogroups A, C, W, Y and X at Visits Day 28 and Day 112.&#xD;
For subjects with a pre-vaccination rSBA titer &lt; 8, a post-vaccination titer of ≥ 32;&#xD;
For subjects with a pre-vaccination rSBA titer ≥ 8, an increase in rSBA titer of at least 4 times the pre-vaccination titer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean of rSBA Titres</measure>
    <time_frame>112 Days</time_frame>
    <description>rSBA GMT for serogroups A, C, W, Y and X at Visits Day 0, Day 28, Day 84 and Day 112</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Solicited Reactions</measure>
    <time_frame>7 days post each vaccination</time_frame>
    <description>Solicited local and systemic AEs reported during the 7 days after each vaccination (Days 0-6 and Days 84-90);</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>112 Days</time_frame>
    <description>Unsolicited AEs reported during 28 days after each vaccination (Days 0-27 and Days 84-111);</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other Adverse Events</measure>
    <time_frame>168 Days</time_frame>
    <description>AEs leading to premature withdrawal during the entire study period;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serious Adverse Events</measure>
    <time_frame>168 Days</time_frame>
    <description>SAEs reported during the entire study period</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">375</enrollment>
  <condition>Meningitis, Meningococcal</condition>
  <arm_group>
    <arm_group_label>Adjuvanted study formulation NmCV-5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W &amp; X.&#xD;
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-adjuvanted study formulation NmCV-5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W &amp; X.&#xD;
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Menactra</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects in this arm will licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, &amp; W viz. Menactra.&#xD;
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Non-adjuvanted study formulation NmCV-5</intervention_name>
    <description>Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&amp;X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&amp;X conjugated to tetanus toxoid and C,Y&amp;W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.</description>
    <arm_group_label>Non-adjuvanted study formulation NmCV-5</arm_group_label>
    <other_name>MenACYWX</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Adjuvanted study formulation NmCV-5</intervention_name>
    <description>Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&amp;X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&amp;X conjugated to tetanus toxoid and C,Y&amp;W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine</description>
    <arm_group_label>Adjuvanted study formulation NmCV-5</arm_group_label>
    <other_name>Adj MenACYWX</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Menactra</intervention_name>
    <description>Menactra is available as ready to used solution containing polysacchride antigens A,C,Y&amp;WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.</description>
    <arm_group_label>Menactra</arm_group_label>
    <other_name>MenACYW-D</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female children between 12 months and 16 months old inclusive (minimum 365&#xD;
             days of age and maximum 16 months plus 29 days of age);&#xD;
&#xD;
          -  For whom parent(s)/legal guardian(s) have given written informed consent after the&#xD;
             nature of the study has been explained according to local regulatory requirements;&#xD;
&#xD;
          -  Who the investigator believes that their parent(s)/ guardian(s) will be available for&#xD;
             all the subject visits and would comply with the requirements of the protocol (e.g.,&#xD;
             timely reporting of adverse events, availability for study site visits and home&#xD;
             visits);&#xD;
&#xD;
          -  Individuals in good health as determined by the outcome of medical history, physical&#xD;
             examination and clinical judgment of the investigator.&#xD;
&#xD;
          -  Individuals who completed their local infant EPI schedule through 9 months of age&#xD;
             (except MenAfriVac dose). A birth dose of OPV is not required)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of any meningococcal vaccine administration.&#xD;
&#xD;
          -  Current or previous, confirmed or suspected disease caused by N. meningitidis.&#xD;
&#xD;
          -  Household contact with and/or intimate exposure to an individual with any laboratory&#xD;
             confirmed N. meningitidis infection within 60 days of enrolment.&#xD;
&#xD;
          -  History of severe allergic reactions after previous vaccinations or hypersensitivity&#xD;
             to any study vaccine component including tetanus, diphtheria and diphtheria toxoid&#xD;
             (CRM197).&#xD;
&#xD;
          -  Acute or chronic, clinically significant pulmonary, cardiovascular, metabolic,&#xD;
             neurological, hepatic, or renal functional abnormality, as determined by medical&#xD;
             history or physical examination.&#xD;
&#xD;
          -  Any confirmed or suspected condition with impaired/altered function of immune system&#xD;
             (immunodeficient or autoimmune conditions).&#xD;
&#xD;
          -  Have any bleeding disorder which is considered as a contraindication to intramuscular&#xD;
             injection or blood draw.&#xD;
&#xD;
          -  Severe acute malnutrition.&#xD;
&#xD;
          -  A family history of congenital or hereditary immunodeficiency.&#xD;
&#xD;
          -  History of either hepatitis B or hepatitis C virus infection or human immunodeficiency&#xD;
             virus infection.&#xD;
&#xD;
          -  Major congenital defects.&#xD;
&#xD;
          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other&#xD;
             immune-modifying drugs within three months prior to the study vaccination or planned&#xD;
             use throughout the study period. (For corticosteroids, this means prednisone, or&#xD;
             equivalent, ≥ 0.5 mg/kg per day. Inhaled, intranasal and topical steroids are&#xD;
             allowed).&#xD;
&#xD;
          -  Administration of blood, blood products and/or plasma derivatives or any parenteral&#xD;
             immunoglobulin preparation in the past 3 months or planned use throughout the study&#xD;
             period.&#xD;
&#xD;
          -  Administration of any vaccine within 28 days prior to enrolment in the study or&#xD;
             planned administration of any vaccine within 14 days before or after any study&#xD;
             vaccination.&#xD;
&#xD;
          -  Use of any investigational or non-registered drug or vaccine within 30 days prior to&#xD;
             the administration of study vaccines or planned during the study.&#xD;
&#xD;
          -  Malaria infection as confirmed by a Rapid Diagnostic Test.&#xD;
&#xD;
          -  Individuals who are close family members of individuals conducting this study.&#xD;
&#xD;
          -  Have experienced a moderate or severe acute infection and/or fever (defined as&#xD;
             temperature ≥ 37.5°C) within 3 days prior to enrolment.&#xD;
&#xD;
          -  Have received systemic antibiotic treatment within 3 days prior to enrolment.&#xD;
&#xD;
          -  Non-residence in the study area or intent to move out within six months.&#xD;
&#xD;
          -  Any condition which, in the opinion of the investigator, might pose additional risk to&#xD;
             the subject due to participation in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Months</minimum_age>
    <maximum_age>16 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Centre pour le Développement des Vaccins du Mali, ex-Institut Marchoux, Ministry of Health, BP251</name>
      <address>
        <city>Bamako</city>
        <zip>BP251</zip>
        <country>Mali</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mali</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <results_first_submitted>August 10, 2021</results_first_submitted>
  <results_first_submitted_qc>August 10, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">September 5, 2021</results_first_posted>
  <last_update_submitted>August 10, 2021</last_update_submitted>
  <last_update_submitted_qc>August 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Neisseria meningitidis</keyword>
  <keyword>conjugate meningococcal vaccine</keyword>
  <keyword>meningococcal serogroup X</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Meningitis, Meningococcal</mesh_term>
    <mesh_term>Meningitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 11, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/18/NCT03295318/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 29, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/18/NCT03295318/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>A total of 515 toddlers were consented to withhold Mali EPI MenAfriVac vaccination at 9 months and were invited to return at 12 months for a second consent and final eligibility assessment. Among these, 136 were subsequently not consented, of which 127 received MenAfriVac to align with their EPI schedule. 379 participants were subsequently consented and assessed for eligibility, of which 2 did not meet eligibility criteria and 1 withdrew consent prior to randomization, leading to 376 randomized.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Non-adjuvanted Study Formulation NmCV-5</title>
          <description>Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W &amp; X.&#xD;
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.&#xD;
Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&amp;X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&amp;X conjugated to tetanus toxoid and C,Y&amp;W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.</description>
        </group>
        <group group_id="P2">
          <title>Adjuvanted Study Formulation NmCV-5</title>
          <description>Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W &amp; X.&#xD;
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.&#xD;
Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&amp;X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&amp;X conjugated to tetanus toxoid and C,Y&amp;W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine</description>
        </group>
        <group group_id="P3">
          <title>Menactra</title>
          <description>Subjects in this arm will licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, &amp; W viz. Menactra.&#xD;
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.&#xD;
Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y&amp;WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="150"/>
                <participants group_id="P2" count="150"/>
                <participants group_id="P3" count="76"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received First Vaccination</title>
              <participants_list>
                <participants group_id="P1" count="149">1 subject withdrew consent after randomization, but prior to vaccination.</participants>
                <participants group_id="P2" count="150"/>
                <participants group_id="P3" count="76"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Second Vaccination</title>
              <participants_list>
                <participants group_id="P1" count="144"/>
                <participants group_id="P2" count="145"/>
                <participants group_id="P3" count="73"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="144"/>
                <participants group_id="P2" count="145"/>
                <participants group_id="P3" count="71"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject prior to initial vaccination</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>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Subject discontinued due to travel</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <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>Non-adjuvanted Study Formulation NmCV-5</title>
          <description>Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W &amp; X.&#xD;
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.&#xD;
Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&amp;X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&amp;X conjugated to tetanus toxoid and C,Y&amp;W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.</description>
        </group>
        <group group_id="B2">
          <title>Adjuvanted Study Formulation NmCV-5</title>
          <description>Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W &amp; X.&#xD;
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.&#xD;
Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&amp;X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&amp;X conjugated to tetanus toxoid and C,Y&amp;W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine</description>
        </group>
        <group group_id="B3">
          <title>Menactra</title>
          <description>Subjects in this arm will licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, &amp; W viz. Menactra.&#xD;
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.&#xD;
Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y&amp;WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.</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="149"/>
            <count group_id="B2" value="150"/>
            <count group_id="B3" value="76"/>
            <count group_id="B4" value="375"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12.1" spread="0.60"/>
                    <measurement group_id="B2" value="12.1" spread="0.53"/>
                    <measurement group_id="B3" value="12.1" spread="0.44"/>
                    <measurement group_id="B4" value="12.1" spread="0.54"/>
                  </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="73"/>
                    <measurement group_id="B2" value="68"/>
                    <measurement group_id="B3" value="36"/>
                    <measurement group_id="B4" value="177"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="76"/>
                    <measurement group_id="B2" value="82"/>
                    <measurement group_id="B3" value="40"/>
                    <measurement group_id="B4" value="198"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="149"/>
                    <measurement group_id="B2" value="150"/>
                    <measurement group_id="B3" value="76"/>
                    <measurement group_id="B4" value="375"/>
                  </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 group_id="B4" value="0"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </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 group_id="B4" 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 group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="149"/>
                    <measurement group_id="B2" value="150"/>
                    <measurement group_id="B3" value="76"/>
                    <measurement group_id="B4" value="375"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </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 group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Length (cm)</title>
          <units>centimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="72.94" spread="2.533"/>
                    <measurement group_id="B2" value="73.03" spread="2.858"/>
                    <measurement group_id="B3" value="72.59" spread="2.460"/>
                    <measurement group_id="B4" value="72.91" spread="2.652"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight (kg)</title>
          <units>kilograms</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.81" spread="1.002"/>
                    <measurement group_id="B2" value="8.89" spread="1.140"/>
                    <measurement group_id="B3" value="8.77" spread="1.007"/>
                    <measurement group_id="B4" value="8.83" spread="1.059"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Temperature (°C)</title>
          <units>Celsius</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36.25" spread="0.266"/>
                    <measurement group_id="B2" value="36.24" spread="0.299"/>
                    <measurement group_id="B3" value="36.24" spread="0.270"/>
                    <measurement group_id="B4" value="36.25" spread="0.279"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Heart Rate (beats/min)</title>
          <units>Beats/minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="110.8" spread="5.80"/>
                    <measurement group_id="B2" value="111.3" spread="5.74"/>
                    <measurement group_id="B3" value="110.8" spread="6.09"/>
                    <measurement group_id="B4" value="111.0" spread="5.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Respiratory Rate (breaths per minute)</title>
          <units>Breaths per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31.8" spread="3.00"/>
                    <measurement group_id="B2" value="31.7" spread="2.67"/>
                    <measurement group_id="B3" value="32.6" spread="3.05"/>
                    <measurement group_id="B4" value="31.9" spread="2.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Severe Solicited Adverse Event</title>
        <description>Percentage of subjects with at least one severe solicited AE within 7 days after any study vaccination (Days 0-6 and Days 84-90)</description>
        <time_frame>7 days post each vaccination</time_frame>
        <population>Analysis population different for severe solicited AEs within 7 days after 2nd study vaccination, as number of subjects who received the 2nd dose was less than those that received the first dose. Reasons outlined in Participant Flow.</population>
        <group_list>
          <group group_id="O1">
            <title>Adjuvanted Study Formulation NmCV-5</title>
            <description>Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W &amp; X.&#xD;
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.&#xD;
Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&amp;X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&amp;X conjugated to tetanus toxoid and C,Y&amp;W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine</description>
          </group>
          <group group_id="O2">
            <title>Non-adjuvanted Study Formulation NmCV-5</title>
            <description>Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W &amp; X.&#xD;
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.&#xD;
Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&amp;X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&amp;X conjugated to tetanus toxoid and C,Y&amp;W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.</description>
          </group>
          <group group_id="O3">
            <title>Menactra</title>
            <description>Subjects in this arm will licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, &amp; W viz. Menactra.&#xD;
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.&#xD;
Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y&amp;WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.</description>
          </group>
        </group_list>
        <measure>
          <title>Severe Solicited Adverse Event</title>
          <description>Percentage of subjects with at least one severe solicited AE within 7 days after any study vaccination (Days 0-6 and Days 84-90)</description>
          <population>Analysis population different for severe solicited AEs within 7 days after 2nd study vaccination, as number of subjects who received the 2nd dose was less than those that received the first dose. Reasons outlined in Participant Flow.</population>
          <units>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="149"/>
                <count group_id="O2" value="150"/>
                <count group_id="O3" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Number of subjects with at least one severe solicited AE reported within 7 days after 1st dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="150"/>
                    <count group_id="O3" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0.00" upper_limit="2.45"/>
                    <measurement group_id="O2" value="0" lower_limit="0.00" upper_limit="2.43"/>
                    <measurement group_id="O3" value="0" lower_limit="0.00" upper_limit="4.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of subjects with at least one severe solicited AE reported within 7 days after 2nd dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="144"/>
                    <count group_id="O2" value="145"/>
                    <count group_id="O3" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0.00" upper_limit="2.53"/>
                    <measurement group_id="O2" value="0" lower_limit="0.00" upper_limit="2.51"/>
                    <measurement group_id="O3" value="0" lower_limit="0.00" upper_limit="4.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Seroprotective rSBA Titres</title>
        <description>Percentage of subjects with rSBA titer ≥ 8 against serogroups A, C, W, Y and X at Visits Day 0 (Baseline), Day 28 (28 days after dose 1), Day 84 (prior to dose 2) and Day 112 (28 days after dose 2)</description>
        <time_frame>112 days</time_frame>
        <population>per protocol population</population>
        <group_list>
          <group group_id="O1">
            <title>Non-adjuvanted Study Formulation NmCV-5</title>
            <description>Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W &amp; X.&#xD;
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.&#xD;
Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&amp;X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&amp;X conjugated to tetanus toxoid and C,Y&amp;W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.</description>
          </group>
          <group group_id="O2">
            <title>Adjuvanted Study Formulation NmCV-5</title>
            <description>Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W &amp; X.&#xD;
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.&#xD;
Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&amp;X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&amp;X conjugated to tetanus toxoid and C,Y&amp;W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine</description>
          </group>
          <group group_id="O3">
            <title>Menactra</title>
            <description>Subjects in this arm will licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, &amp; W viz. Menactra.&#xD;
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.&#xD;
Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y&amp;WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.</description>
          </group>
        </group_list>
        <measure>
          <title>Seroprotective rSBA Titres</title>
          <description>Percentage of subjects with rSBA titer ≥ 8 against serogroups A, C, W, Y and X at Visits Day 0 (Baseline), Day 28 (28 days after dose 1), Day 84 (prior to dose 2) and Day 112 (28 days after dose 2)</description>
          <population>per protocol 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="144"/>
                <count group_id="O2" value="144"/>
                <count group_id="O3" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serogroup A Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="19"/>
                    <measurement group_id="O3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup A Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="144"/>
                    <measurement group_id="O2" value="144"/>
                    <measurement group_id="O3" value="71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup A Day 84</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="144"/>
                    <measurement group_id="O2" value="144"/>
                    <measurement group_id="O3" value="71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup A Day 112</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="144"/>
                    <measurement group_id="O2" value="144"/>
                    <measurement group_id="O3" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup C Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup C Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="143"/>
                    <measurement group_id="O2" value="143"/>
                    <measurement group_id="O3" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup C Day 84</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="141"/>
                    <measurement group_id="O2" value="139"/>
                    <measurement group_id="O3" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup C Day 112</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="144"/>
                    <measurement group_id="O2" value="144"/>
                    <measurement group_id="O3" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup W Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup W Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="142"/>
                    <measurement group_id="O2" value="141"/>
                    <measurement group_id="O3" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup W Day 84</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="140"/>
                    <measurement group_id="O2" value="142"/>
                    <measurement group_id="O3" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup W Day 112</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="144"/>
                    <measurement group_id="O2" value="144"/>
                    <measurement group_id="O3" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup X Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup X Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="144"/>
                    <measurement group_id="O2" value="143"/>
                    <measurement group_id="O3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup X Day 84</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="144"/>
                    <measurement group_id="O2" value="143"/>
                    <measurement group_id="O3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup X Day 112</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="143"/>
                    <measurement group_id="O2" value="144"/>
                    <measurement group_id="O3" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup Y Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="21"/>
                    <measurement group_id="O3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup Y Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="141"/>
                    <measurement group_id="O2" value="143"/>
                    <measurement group_id="O3" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup Y Day 84</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="141"/>
                    <measurement group_id="O2" value="143"/>
                    <measurement group_id="O3" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup Y Day 112</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="144"/>
                    <measurement group_id="O2" value="144"/>
                    <measurement group_id="O3" value="71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Long Term Protective rSBA Titres</title>
        <description>Percentage of subjects with rSBA titer ≥ 128 against serogroups A, C, W, Y and X at Visits Day 0, Day 28, Day 84 and Day 112</description>
        <time_frame>112 days</time_frame>
        <population>Per Protocol Population</population>
        <group_list>
          <group group_id="O1">
            <title>Non-adjuvanted Study Formulation NmCV-5</title>
            <description>Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W &amp; X.&#xD;
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.&#xD;
Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&amp;X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&amp;X conjugated to tetanus toxoid and C,Y&amp;W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.</description>
          </group>
          <group group_id="O2">
            <title>Adjuvanted Study Formulation NmCV-5</title>
            <description>Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W &amp; X.&#xD;
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.&#xD;
Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&amp;X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&amp;X conjugated to tetanus toxoid and C,Y&amp;W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine</description>
          </group>
          <group group_id="O3">
            <title>Menactra</title>
            <description>Subjects in this arm will receive licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, &amp; W viz. Menactra.&#xD;
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.&#xD;
Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y&amp;WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.</description>
          </group>
        </group_list>
        <measure>
          <title>Long Term Protective rSBA Titres</title>
          <description>Percentage of subjects with rSBA titer ≥ 128 against serogroups A, C, W, Y and X at Visits Day 0, Day 28, Day 84 and Day 112</description>
          <population>Per Protocol 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="144"/>
                <count group_id="O2" value="144"/>
                <count group_id="O3" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serogroup A Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="18"/>
                    <measurement group_id="O3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup A Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="144"/>
                    <measurement group_id="O2" value="144"/>
                    <measurement group_id="O3" value="71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup A Day 84</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="144"/>
                    <measurement group_id="O2" value="143"/>
                    <measurement group_id="O3" value="71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup A Day 112</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="144"/>
                    <measurement group_id="O2" value="144"/>
                    <measurement group_id="O3" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup C Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup C Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="142"/>
                    <measurement group_id="O2" value="140"/>
                    <measurement group_id="O3" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup C Day 84</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="133"/>
                    <measurement group_id="O2" value="131"/>
                    <measurement group_id="O3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup C Day 112</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="144"/>
                    <measurement group_id="O2" value="144"/>
                    <measurement group_id="O3" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup W Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup W Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="142"/>
                    <measurement group_id="O2" value="141"/>
                    <measurement group_id="O3" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup W Day 84</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="137"/>
                    <measurement group_id="O2" value="139"/>
                    <measurement group_id="O3" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup W Day 112</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="144"/>
                    <measurement group_id="O2" value="144"/>
                    <measurement group_id="O3" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup X Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup X Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="144"/>
                    <measurement group_id="O2" value="143"/>
                    <measurement group_id="O3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup X Day 84</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="144"/>
                    <measurement group_id="O2" value="143"/>
                    <measurement group_id="O3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup X Day 112</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="143"/>
                    <measurement group_id="O2" value="144"/>
                    <measurement group_id="O3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup Y Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="21"/>
                    <measurement group_id="O3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup Y Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="140"/>
                    <measurement group_id="O2" value="143"/>
                    <measurement group_id="O3" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup Y Day 84</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="138"/>
                    <measurement group_id="O2" value="141"/>
                    <measurement group_id="O3" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup Y Day 112</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="144"/>
                    <measurement group_id="O2" value="144"/>
                    <measurement group_id="O3" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rise in rSBA Titres</title>
        <description>Percentage of subjects with fourfold rise in rSBA titers against serogroups A, C, W, Y and X at Visits Day 28 and Day 112.&#xD;
For subjects with a pre-vaccination rSBA titer &lt; 8, a post-vaccination titer of ≥ 32;&#xD;
For subjects with a pre-vaccination rSBA titer ≥ 8, an increase in rSBA titer of at least 4 times the pre-vaccination titer</description>
        <time_frame>112 days</time_frame>
        <population>Per protocol population</population>
        <group_list>
          <group group_id="O1">
            <title>Non-adjuvanted Study Formulation NmCV-5</title>
            <description>Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W &amp; X.&#xD;
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.&#xD;
Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&amp;X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&amp;X conjugated to tetanus toxoid and C,Y&amp;W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.</description>
          </group>
          <group group_id="O2">
            <title>Adjuvanted Study Formulation NmCV-5</title>
            <description>Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W &amp; X.&#xD;
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.&#xD;
Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&amp;X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&amp;X conjugated to tetanus toxoid and C,Y&amp;W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine</description>
          </group>
          <group group_id="O3">
            <title>Menactra</title>
            <description>Subjects in this arm will receive licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, &amp; W viz. Menactra.&#xD;
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.&#xD;
Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y&amp;WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.</description>
          </group>
        </group_list>
        <measure>
          <title>Rise in rSBA Titres</title>
          <description>Percentage of subjects with fourfold rise in rSBA titers against serogroups A, C, W, Y and X at Visits Day 28 and Day 112.&#xD;
For subjects with a pre-vaccination rSBA titer &lt; 8, a post-vaccination titer of ≥ 32;&#xD;
For subjects with a pre-vaccination rSBA titer ≥ 8, an increase in rSBA titer of at least 4 times the pre-vaccination titer</description>
          <population>Per protocol 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="144"/>
                <count group_id="O2" value="144"/>
                <count group_id="O3" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serogroup A: Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="143"/>
                    <measurement group_id="O2" value="144"/>
                    <measurement group_id="O3" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup A: Day 112</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="143"/>
                    <measurement group_id="O2" value="144"/>
                    <measurement group_id="O3" value="71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup C: Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="141"/>
                    <measurement group_id="O2" value="141"/>
                    <measurement group_id="O3" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup C: Day 112</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="142"/>
                    <measurement group_id="O2" value="144"/>
                    <measurement group_id="O3" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup W: Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="140"/>
                    <measurement group_id="O2" value="140"/>
                    <measurement group_id="O3" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup W: Day 112</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="142"/>
                    <measurement group_id="O2" value="143"/>
                    <measurement group_id="O3" value="71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup X: Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="144"/>
                    <measurement group_id="O2" value="142"/>
                    <measurement group_id="O3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup X: Day 112</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="143"/>
                    <measurement group_id="O2" value="143"/>
                    <measurement group_id="O3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup Y: Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="140"/>
                    <measurement group_id="O2" value="142"/>
                    <measurement group_id="O3" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup Y: Day 112</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="144"/>
                    <measurement group_id="O2" value="142"/>
                    <measurement group_id="O3" value="71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean of rSBA Titres</title>
        <description>rSBA GMT for serogroups A, C, W, Y and X at Visits Day 0, Day 28, Day 84 and Day 112</description>
        <time_frame>112 Days</time_frame>
        <population>Per protocol population</population>
        <group_list>
          <group group_id="O1">
            <title>Non-adjuvanted Study Formulation NmCV-5</title>
            <description>Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W &amp; X.&#xD;
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.&#xD;
Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&amp;X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&amp;X conjugated to tetanus toxoid and C,Y&amp;W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.</description>
          </group>
          <group group_id="O2">
            <title>Adjuvanted Study Formulation NmCV-5</title>
            <description>Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W &amp; X.&#xD;
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.&#xD;
Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&amp;X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&amp;X conjugated to tetanus toxoid and C,Y&amp;W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine</description>
          </group>
          <group group_id="O3">
            <title>Menactra</title>
            <description>Subjects in this arm will receive licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, &amp; W viz. Menactra.&#xD;
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.&#xD;
Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y&amp;WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean of rSBA Titres</title>
          <description>rSBA GMT for serogroups A, C, W, Y and X at Visits Day 0, Day 28, Day 84 and Day 112</description>
          <population>Per protocol population</population>
          <units>Geometric Mean rSBA 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="144"/>
                <count group_id="O2" value="144"/>
                <count group_id="O3" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serogroup A Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8" lower_limit="2.81" upper_limit="5.18"/>
                    <measurement group_id="O2" value="4.3" lower_limit="3.08" upper_limit="5.89"/>
                    <measurement group_id="O3" value="4.4" lower_limit="2.74" upper_limit="6.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup A Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7732.2" lower_limit="6462.42" upper_limit="9251.52"/>
                    <measurement group_id="O2" value="7368.8" lower_limit="6210.80" upper_limit="8742.81"/>
                    <measurement group_id="O3" value="3866.1" lower_limit="2841.91" upper_limit="5259.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup A Day 84</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4687.0" lower_limit="3919.72" upper_limit="5604.44"/>
                    <measurement group_id="O2" value="4488.3" lower_limit="3600.74" upper_limit="5594.57"/>
                    <measurement group_id="O3" value="2786.9" lower_limit="2003.18" upper_limit="3877.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup A Day 112</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6226.3" lower_limit="5435.42" upper_limit="7132.33"/>
                    <measurement group_id="O2" value="6166.7" lower_limit="5375.47" upper_limit="7047.35"/>
                    <measurement group_id="O3" value="4871.0" lower_limit="3833.59" upper_limit="6189.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup C Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" lower_limit="1.97" upper_limit="2.37"/>
                    <measurement group_id="O2" value="2.0" lower_limit="NA" upper_limit="NA">*For Serogroup C, all subjects have same titer values at baseline in Adjuvanted NmCV-5 and MenACWY-D arms.</measurement>
                    <measurement group_id="O3" value="2.0" lower_limit="NA" upper_limit="NA">*For Serogroup C, all subjects have same titer values at baseline in Adjuvanted NmCV-5 and MenACWY-D arms.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup C Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1143.9" lower_limit="929.32" upper_limit="1407.98"/>
                    <measurement group_id="O2" value="1095.4" lower_limit="877.66" upper_limit="1367.12"/>
                    <measurement group_id="O3" value="67.8" lower_limit="39.69" upper_limit="115.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup C Day 84</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="436.8" lower_limit="342.33" upper_limit="557.34"/>
                    <measurement group_id="O2" value="348.4" lower_limit="272.51" upper_limit="445.33"/>
                    <measurement group_id="O3" value="29.6" lower_limit="18.73" upper_limit="46.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup C Day 112</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1366.9" lower_limit="1173.58" upper_limit="1592.01"/>
                    <measurement group_id="O2" value="1393.4" lower_limit="1200.54" upper_limit="1617.35"/>
                    <measurement group_id="O3" value="410.3" lower_limit="324.93" upper_limit="518.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup W Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8" lower_limit="2.22" upper_limit="3.52"/>
                    <measurement group_id="O2" value="2.5" lower_limit="2.09" upper_limit="2.91"/>
                    <measurement group_id="O3" value="2.2" lower_limit="1.91" upper_limit="2.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup W Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6533.4" lower_limit="4868.00" upper_limit="8768.46"/>
                    <measurement group_id="O2" value="5363.2" lower_limit="3927.83" upper_limit="7323.21"/>
                    <measurement group_id="O3" value="1127.5" lower_limit="614.73" upper_limit="2067.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup W Day 84</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2555.6" lower_limit="1839.63" upper_limit="3550.22"/>
                    <measurement group_id="O2" value="2222.6" lower_limit="1673.59" upper_limit="2951.80"/>
                    <measurement group_id="O3" value="483.3" lower_limit="242.96" upper_limit="961.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup W Day 112</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8035.8" lower_limit="6255.62" upper_limit="10322.51"/>
                    <measurement group_id="O2" value="7056.4" lower_limit="5622.17" upper_limit="8856.57"/>
                    <measurement group_id="O3" value="2482.8" lower_limit="1567.27" upper_limit="3933.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup X Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5" lower_limit="2.70" upper_limit="4.61"/>
                    <measurement group_id="O2" value="3.2" lower_limit="2.50" upper_limit="4.19"/>
                    <measurement group_id="O3" value="3.2" lower_limit="2.21" upper_limit="4.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup X Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7548.3" lower_limit="6442.99" upper_limit="8843.32"/>
                    <measurement group_id="O2" value="8152.7" lower_limit="6717.91" upper_limit="9893.84"/>
                    <measurement group_id="O3" value="6.9" lower_limit="3.82" upper_limit="12.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup X Day 84</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3511.3" lower_limit="2934.73" upper_limit="4201.08"/>
                    <measurement group_id="O2" value="3113.2" lower_limit="2552.53" upper_limit="3796.93"/>
                    <measurement group_id="O3" value="6.7" lower_limit="3.73" upper_limit="11.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup X Day 112</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5363.2" lower_limit="4523.30" upper_limit="6359.15"/>
                    <measurement group_id="O2" value="6286.6" lower_limit="5515.16" upper_limit="7165.86"/>
                    <measurement group_id="O3" value="11.6" lower_limit="6.35" upper_limit="21.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup Y Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" lower_limit="2.74" upper_limit="4.64"/>
                    <measurement group_id="O2" value="4.1" lower_limit="3.08" upper_limit="5.55"/>
                    <measurement group_id="O3" value="3.9" lower_limit="2.63" upper_limit="5.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup Y Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2366.2" lower_limit="1837.37" upper_limit="3047.14"/>
                    <measurement group_id="O2" value="3010.0" lower_limit="2490.61" upper_limit="3637.74"/>
                    <measurement group_id="O3" value="676.9" lower_limit="392.43" upper_limit="1167.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup Y Day 84</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1171.7" lower_limit="891.95" upper_limit="1539.31"/>
                    <measurement group_id="O2" value="1386.8" lower_limit="1129.10" upper_limit="1703.21"/>
                    <measurement group_id="O3" value="426.4" lower_limit="252.21" upper_limit="720.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup Y Day 112</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3189.0" lower_limit="2700.52" upper_limit="3765.84"/>
                    <measurement group_id="O2" value="3266.7" lower_limit="2800.84" upper_limit="3810.01"/>
                    <measurement group_id="O3" value="1194.5" lower_limit="809.00" upper_limit="1763.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Solicited Reactions</title>
        <description>Solicited local and systemic AEs reported during the 7 days after each vaccination (Days 0-6 and Days 84-90);</description>
        <time_frame>7 days post each vaccination</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>Non-adjuvanted NmCV-5 (Days 0-6)</title>
            <description>Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W &amp; X.&#xD;
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by at least 84 days.&#xD;
Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&amp;X (NmCV-5) is available as lyophilised powder of polysaccharide antigens A&amp;X conjugated to tetanus toxoid and C,Y&amp;W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.</description>
          </group>
          <group group_id="O2">
            <title>Adjuvanted NmCV-5 (Days 0-6)</title>
            <description>Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W &amp; X.&#xD;
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by at least 84 days.&#xD;
Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&amp;X (NmCV-5) is available as lyophilised powder of polysaccharide antigens A&amp;X conjugated to tetanus toxoid and C,Y&amp;W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine</description>
          </group>
          <group group_id="O3">
            <title>Menactra (Days 0-6)</title>
            <description>Subjects in this arm will receive licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, &amp; W viz. Menactra.&#xD;
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.&#xD;
Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y&amp;WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.</description>
          </group>
          <group group_id="O4">
            <title>Non-adjuvanted NmCV-5 (Days 84-90)</title>
            <description>Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W &amp; X.&#xD;
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by at least 84 days.&#xD;
Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&amp;X (NmCV-5) is available as lyophilised powder of polysaccharide antigens A&amp;X conjugated to tetanus toxoid and C,Y&amp;W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.</description>
          </group>
          <group group_id="O5">
            <title>Adjuvanted NmCV-5 (Days 84-90)</title>
            <description>Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W &amp; X.&#xD;
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by at least 84 days.&#xD;
Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&amp;X (NmCV-5) is available as lyophilised powder of polysaccharide antigens A&amp;X conjugated to tetanus toxoid and C,Y&amp;W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine</description>
          </group>
          <group group_id="O6">
            <title>Menactra (Days 84-90)</title>
            <description>Subjects in this arm will receive licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, &amp; W viz. Menactra.&#xD;
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.&#xD;
Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y&amp;WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.</description>
          </group>
        </group_list>
        <measure>
          <title>Solicited Reactions</title>
          <description>Solicited local and systemic AEs reported during the 7 days after each vaccination (Days 0-6 and Days 84-90);</description>
          <population>Safety 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="149"/>
                <count group_id="O2" value="150"/>
                <count group_id="O3" value="76"/>
                <count group_id="O4" value="144"/>
                <count group_id="O5" value="145"/>
                <count group_id="O6" value="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Number of subjects with any Solicited AE</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="150"/>
                    <count group_id="O3" value="76"/>
                    <count group_id="O4" value="144"/>
                    <count group_id="O5" value="145"/>
                    <count group_id="O6" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Solicited Local AE</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="144"/>
                    <count group_id="O2" value="145"/>
                    <count group_id="O3" value="73"/>
                    <count group_id="O4" value="144"/>
                    <count group_id="O5" value="145"/>
                    <count group_id="O6" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tenderness</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="150"/>
                    <count group_id="O3" value="76"/>
                    <count group_id="O4" value="144"/>
                    <count group_id="O5" value="145"/>
                    <count group_id="O6" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling/Induration</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="150"/>
                    <count group_id="O3" value="76"/>
                    <count group_id="O4" value="144"/>
                    <count group_id="O5" value="145"/>
                    <count group_id="O6" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Solicited Systemic AE</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="150"/>
                    <count group_id="O3" value="76"/>
                    <count group_id="O4" value="144"/>
                    <count group_id="O5" value="145"/>
                    <count group_id="O6" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Irritability</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="150"/>
                    <count group_id="O3" value="76"/>
                    <count group_id="O4" value="144"/>
                    <count group_id="O5" value="145"/>
                    <count group_id="O6" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drowsiness</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="150"/>
                    <count group_id="O3" value="76"/>
                    <count group_id="O4" value="144"/>
                    <count group_id="O5" value="145"/>
                    <count group_id="O6" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Decrease eating</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="150"/>
                    <count group_id="O3" value="76"/>
                    <count group_id="O4" value="144"/>
                    <count group_id="O5" value="145"/>
                    <count group_id="O6" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vomiting</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="150"/>
                    <count group_id="O3" value="76"/>
                    <count group_id="O4" value="144"/>
                    <count group_id="O5" value="145"/>
                    <count group_id="O6" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="1"/>
                  </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="149"/>
                    <count group_id="O2" value="150"/>
                    <count group_id="O3" value="76"/>
                    <count group_id="O4" value="144"/>
                    <count group_id="O5" value="145"/>
                    <count group_id="O6" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adverse Events</title>
        <description>Unsolicited AEs reported during 28 days after each vaccination (Days 0-27 and Days 84-111);</description>
        <time_frame>112 Days</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>Non-adjuvanted NmCV-5 (Days 0-27)</title>
            <description>Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W &amp; X.&#xD;
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.&#xD;
Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&amp;X (NmCV-5) is available as lyophilised powder of polysaccharide antigens A&amp;X conjugated to tetanus toxoid and C,Y&amp;W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.</description>
          </group>
          <group group_id="O2">
            <title>Adjuvanted NmCV-5 (Days 0-27)</title>
            <description>Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W &amp; X.&#xD;
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.&#xD;
Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&amp;X (NmCV-5) is available as lyophilised powder of polysaccharide antigens A&amp;X conjugated to tetanus toxoid and C,Y&amp;W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine</description>
          </group>
          <group group_id="O3">
            <title>Menactra (Days 0-27)</title>
            <description>Subjects in this arm will receive licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, &amp; W viz. Menactra.&#xD;
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.&#xD;
Menactra: Menactra is available as ready to used solution containing polysaccharide antigens A,C,Y&amp;WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.</description>
          </group>
          <group group_id="O4">
            <title>Non-adjuvanted NmCV-5 (Days 84-111)</title>
            <description>Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W &amp; X.&#xD;
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.&#xD;
Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&amp;X (NmCV-5) is available as lyophilised powder of polysaccharide antigens A&amp;X conjugated to tetanus toxoid and C,Y&amp;W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.</description>
          </group>
          <group group_id="O5">
            <title>Adjuvanted NmCV-5 (Days 84-111)</title>
            <description>Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W &amp; X.&#xD;
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.&#xD;
Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&amp;X (NmCV-5) is available as lyophilised powder of polysaccharide antigens A&amp;X conjugated to tetanus toxoid and C,Y&amp;W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine</description>
          </group>
          <group group_id="O6">
            <title>Menactra (Days 84-111)</title>
            <description>Subjects in this arm will receive licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, &amp; W viz. Menactra.&#xD;
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.&#xD;
Menactra: Menactra is available as ready to used solution containing polysaccharide antigens A,C,Y&amp;WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.</description>
          </group>
        </group_list>
        <measure>
          <title>Adverse Events</title>
          <description>Unsolicited AEs reported during 28 days after each vaccination (Days 0-27 and Days 84-111);</description>
          <population>Safety 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="149"/>
                <count group_id="O2" value="150"/>
                <count group_id="O3" value="76"/>
                <count group_id="O4" value="144"/>
                <count group_id="O5" value="145"/>
                <count group_id="O6" value="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At least one Unsolicited AE</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="150"/>
                    <count group_id="O3" value="76"/>
                    <count group_id="O4" value="144"/>
                    <count group_id="O5" value="145"/>
                    <count group_id="O6" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                    <measurement group_id="O2" value="39"/>
                    <measurement group_id="O3" value="23"/>
                    <measurement group_id="O4" value="23"/>
                    <measurement group_id="O5" value="17"/>
                    <measurement group_id="O6" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least one related Unsolicited AE</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="144"/>
                    <count group_id="O2" value="145"/>
                    <count group_id="O3" value="73"/>
                    <count group_id="O4" value="144"/>
                    <count group_id="O5" value="145"/>
                    <count group_id="O6" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least one serious unsolicited AE</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="150"/>
                    <count group_id="O3" value="76"/>
                    <count group_id="O4" value="144"/>
                    <count group_id="O5" value="145"/>
                    <count group_id="O6" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least one serious related unsolicited AE</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="150"/>
                    <count group_id="O3" value="76"/>
                    <count group_id="O4" value="144"/>
                    <count group_id="O5" value="145"/>
                    <count group_id="O6" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unsolicited AEs leading to withdrawal from Study</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="150"/>
                    <count group_id="O3" value="76"/>
                    <count group_id="O4" value="144"/>
                    <count group_id="O5" value="145"/>
                    <count group_id="O6" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unsolicited AEs leading to withdrawal from study vaccination but remaining in the study</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="150"/>
                    <count group_id="O3" value="76"/>
                    <count group_id="O4" value="144"/>
                    <count group_id="O5" value="145"/>
                    <count group_id="O6" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>unsolicited AEs leading to hospitalization</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="150"/>
                    <count group_id="O3" value="76"/>
                    <count group_id="O4" value="144"/>
                    <count group_id="O5" value="145"/>
                    <count group_id="O6" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unsolicited AEs leading to Death</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="150"/>
                    <count group_id="O3" value="76"/>
                    <count group_id="O4" value="144"/>
                    <count group_id="O5" value="145"/>
                    <count group_id="O6" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Other Adverse Events</title>
        <description>AEs leading to premature withdrawal during the entire study period;</description>
        <time_frame>168 Days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Non-adjuvanted Study Formulation NmCV-5</title>
            <description>Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W &amp; X.&#xD;
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.&#xD;
Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&amp;X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&amp;X conjugated to tetanus toxoid and C,Y&amp;W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.</description>
          </group>
          <group group_id="O2">
            <title>Adjuvanted Study Formulation NmCV-5</title>
            <description>Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W &amp; X.&#xD;
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.&#xD;
Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&amp;X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&amp;X conjugated to tetanus toxoid and C,Y&amp;W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine</description>
          </group>
          <group group_id="O3">
            <title>Menactra</title>
            <description>Subjects in this arm will licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, &amp; W viz. Menactra.&#xD;
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.&#xD;
Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y&amp;WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.</description>
          </group>
        </group_list>
        <measure>
          <title>Other Adverse Events</title>
          <description>AEs leading to premature withdrawal during the entire study period;</description>
          <units>Number of events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="149"/>
                <count group_id="O2" value="150"/>
                <count group_id="O3" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Serious Adverse Events</title>
        <description>SAEs reported during the entire study period</description>
        <time_frame>168 Days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Non-adjuvanted Study Formulation NmCV-5</title>
            <description>Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W &amp; X.&#xD;
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.&#xD;
Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&amp;X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&amp;X conjugated to tetanus toxoid and C,Y&amp;W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.</description>
          </group>
          <group group_id="O2">
            <title>Adjuvanted Study Formulation NmCV-5</title>
            <description>Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W &amp; X.&#xD;
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.&#xD;
Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&amp;X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&amp;X conjugated to tetanus toxoid and C,Y&amp;W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine</description>
          </group>
          <group group_id="O3">
            <title>Menactra</title>
            <description>Subjects in this arm will licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, &amp; W viz. Menactra.&#xD;
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.&#xD;
Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y&amp;WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.</description>
          </group>
        </group_list>
        <measure>
          <title>Serious Adverse Events</title>
          <description>SAEs reported during the entire study period</description>
          <units>Number of events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="149"/>
                <count group_id="O2" value="150"/>
                <count group_id="O3" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Non-adjuvanted NmCV-5 Dose 1</title>
          <description>Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W &amp; X.&#xD;
First dose to be administered is 0.5 mL intramuscularly.&#xD;
Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&amp;X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&amp;X conjugated to tetanus toxoid and C,Y&amp;W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.</description>
        </group>
        <group group_id="E2">
          <title>Adjuvanted NmCV-5 Dose 1</title>
          <description>Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W &amp; X.&#xD;
First dose to be administered is 0.5 mL intramuscularly.&#xD;
Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&amp;X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&amp;X conjugated to tetanus toxoid and C,Y&amp;W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine</description>
        </group>
        <group group_id="E3">
          <title>Menactra Dose 1</title>
          <description>Subjects in this arm will receive licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, &amp; W viz. Menactra.&#xD;
First dose to be administered is 0.5 mL intramuscularly. Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y&amp;WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.</description>
        </group>
        <group group_id="E4">
          <title>Non-adjuvanted NmCV-5 Dose 2</title>
          <description>Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W &amp; X.&#xD;
Second dose to be administered is 0.5 mL intramuscularly at least 84 days after Non-adjuvanted study formulation NmCV-5 Dose 1.&#xD;
Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&amp;X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&amp;X conjugated to tetanus toxoid and C,Y&amp;W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.</description>
        </group>
        <group group_id="E5">
          <title>Adjuvanted NmCV-5 Dose 2</title>
          <description>Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W &amp; X.&#xD;
Second dose to be administered is 0.5 mL intramuscularly at least 84 days after adjuvanted study formulation NmCV-5 dose 1.&#xD;
Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&amp;X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&amp;X conjugated to tetanus toxoid and C,Y&amp;W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine</description>
        </group>
        <group group_id="E6">
          <title>Menactra Dose 2</title>
          <description>Subjects in this arm will receive licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, &amp; W viz. Menactra.&#xD;
Second dose to be administered is 0.5 mL intramuscularly at least 84 days after Menactra dose 1.&#xD;
Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y&amp;WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA Version 20.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="73"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="73"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Escheria Sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="150"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="73"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="150"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="73"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Burns second degree</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="150"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="73"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA Version 20.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="41" subjects_at_risk="149"/>
                <counts group_id="E2" subjects_affected="44" subjects_at_risk="150"/>
                <counts group_id="E3" subjects_affected="25" subjects_at_risk="76"/>
                <counts group_id="E4" subjects_affected="24" subjects_at_risk="144"/>
                <counts group_id="E5" subjects_affected="17" subjects_at_risk="145"/>
                <counts group_id="E6" subjects_affected="16" subjects_at_risk="73"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="150"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="73"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection Site Tenderness</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="150"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="76"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="73"/>
              </event>
              <event>
                <sub_title>Injection Site Swelling/Induration</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="150"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="73"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="150"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="73"/>
              </event>
              <event>
                <sub_title>Drowsiness</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="150"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="73"/>
              </event>
              <event>
                <sub_title>Decrease Eating</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="150"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="76"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="73"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="149"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="150"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="145"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="73"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="150"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="76"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="145"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="73"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchiolitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="150"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="73"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="149"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="150"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="76"/>
                <counts group_id="E4" events="7" subjects_affected="7" subjects_at_risk="144"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="145"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="73"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="150"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="73"/>
              </event>
              <event>
                <sub_title>Ear Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="150"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="73"/>
              </event>
              <event>
                <sub_title>Furuncle</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="150"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="73"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="149"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="150"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="144"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="145"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="73"/>
              </event>
              <event>
                <sub_title>Impetigo</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="150"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="145"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="73"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="149"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="150"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="76"/>
                <counts group_id="E4" events="7" subjects_affected="7" subjects_at_risk="144"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="145"/>
                <counts group_id="E6" events="5" subjects_affected="5" subjects_at_risk="73"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="149"/>
                <counts group_id="E2" events="12" subjects_affected="11" subjects_at_risk="150"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="144"/>
                <counts group_id="E5" events="5" subjects_affected="5" subjects_at_risk="145"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="73"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="149"/>
                <counts group_id="E2" events="12" subjects_affected="11" subjects_at_risk="150"/>
                <counts group_id="E3" events="8" subjects_affected="7" subjects_at_risk="76"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="145"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="73"/>
              </event>
              <event>
                <sub_title>Varicella</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="150"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="144"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="73"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Thermal Burn</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="150"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="145"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="73"/>
              </event>
              <event>
                <sub_title>Wound</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="150"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="73"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Allergic Cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="150"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="144"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="145"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="73"/>
              </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>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Abhijeet Dharmadhikari</name_or_title>
      <organization>Serum Institute of India Pvt. Ltd.</organization>
      <phone>+91-20-26602855 ext 2855</phone>
      <email>abhijeet.dharmadhikari@seruminstitute.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/NCT03295318
org study id: ACYWX-002
secondary id: CVIA-058
nct id: NCT03295318
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Out of the 13 identified serogroups of Neisseria meningitidis (Nm) the six serogroups (A, B,
      C, W, Y and X) are responsible for majority of infections. Presently available vaccines
      effectively protect against A, B, C, W and Y serogroups; but no vaccine that is protective
      against serogroup X is available yet.

      Serum Institute of India Private Limited (SIIPL) has developed a conjugate vaccine against
      serogroups A, C, Y, W and X (NmCV-5).

      The first-in-human Phase 1 study was among 60 healthy adults in USA did not show no any
      safety issues.

      This phase 2 study is designed to evaluate safety and immunogenicity of the non-adjuvanted
      and adjuvanted formulations of NmCV-5 in healthy children 12-16 months of age, in comparison
      with the licensed quadrivalent meningococcal conjugate vaccine (Menactra®).

      Both vaccines will be administered in two dose schedule 3 months apart. among vaccine-naïve
      healthy subjects in Mali. Safety will be assessed by collecting solicited reactions till day
      7 post each dose whereas adverse events will be collected throughout the study. Each subject
      will be followed up for 84 days post each vaccine dose.

      The vaccine immunogenicity will measured using a rabbit complement serum bactericidal
      activity assay (rSBA).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Observer blind wherein the pharmacist and other study staff involved in vaccine administration will be aware of the treatment allocation.
The other study staff involved in safety assessments will be masked to treatment arm. The laboratory involved in immunogenicity analysis will also be blinded to the treatment allocation.
measure: Severe Solicited Adverse Event
time frame: 7 days post each vaccination
description: Percentage of subjects with at least one severe solicited AE within 7 days after any study vaccination (Days 0-6 and Days 84-90)
measure: Seroprotective rSBA Titres
time frame: 112 days
description: Percentage of subjects with rSBA titer ≥ 8 against serogroups A, C, W, Y and X at Visits Day 0 (Baseline), Day 28 (28 days after dose 1), Day 84 (prior to dose 2) and Day 112 (28 days after dose 2)
measure: Long Term Protective rSBA Titres
time frame: 112 days
description: Percentage of subjects with rSBA titer ≥ 128 against serogroups A, C, W, Y and X at Visits Day 0, Day 28, Day 84 and Day 112
measure: Rise in rSBA Titres
time frame: 112 days
description: Percentage of subjects with fourfold rise in rSBA titers against serogroups A, C, W, Y and X at Visits Day 28 and Day 112.
For subjects with a pre-vaccination rSBA titer < 8, a post-vaccination titer of ≥ 32;
For subjects with a pre-vaccination rSBA titer ≥ 8, an increase in rSBA titer of at least 4 times the pre-vaccination titer
measure: Geometric Mean of rSBA Titres
time frame: 112 Days
description: rSBA GMT for serogroups A, C, W, Y and X at Visits Day 0, Day 28, Day 84 and Day 112
measure: Solicited Reactions
time frame: 7 days post each vaccination
description: Solicited local and systemic AEs reported during the 7 days after each vaccination (Days 0-6 and Days 84-90);
measure: Adverse Events
time frame: 112 Days
description: Unsolicited AEs reported during 28 days after each vaccination (Days 0-27 and Days 84-111);
measure: Other Adverse Events
time frame: 168 Days
description: AEs leading to premature withdrawal during the entire study period;
measure: Serious Adverse Events
time frame: 168 Days
description: SAEs reported during the entire study period
arm group label: Adjuvanted study formulation NmCV-5
arm group type: Experimental
description: Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W & X.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
arm group label: Non-adjuvanted study formulation NmCV-5
arm group type: Experimental
description: Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W & X.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
arm group label: Menactra
arm group type: Active Comparator
description: Subjects in this arm will licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, & W viz. Menactra.
Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days.
intervention type: Biological
intervention name: Non-adjuvanted study formulation NmCV-5
description: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&X conjugated to tetanus toxoid and C,Y&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.
arm group label: Non-adjuvanted study formulation NmCV-5
other name: MenACYWX
intervention type: Biological
intervention name: Adjuvanted study formulation NmCV-5
description: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&X conjugated to tetanus toxoid and C,Y&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine
arm group label: Adjuvanted study formulation NmCV-5
other name: Adj MenACYWX
intervention type: Biological
intervention name: Menactra
description: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.
arm group label: Menactra
other name: MenACYW-D
criteria: 
gender: All
minimum age: 12 Months
maximum age: 16 Months
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Mali
responsible party type: Sponsor
mesh term: Meningitis, Meningococcal
mesh term: Meningitis
sharing ipd: Undecided
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 