<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/NCT02199691</url>
  </required_header>
  <id_info>
    <org_study_id>MET50</org_study_id>
    <secondary_id>U1111-1143-8537</secondary_id>
    <nct_id>NCT02199691</nct_id>
  </id_info>
  <brief_title>Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adolescents</brief_title>
  <official_title>A Phase II Study of the Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adolescents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sanofi Pasteur, a Sanofi Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sanofi</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study was to evaluate the immunogenicity and describe the safety of&#xD;
      Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate&#xD;
      vaccine compared to the licensed vaccine MENVEO® in adolescents 10 to 17 years of age in the&#xD;
      United States (US). This study also evaluated the immunogenicity and safety of MenACYW&#xD;
      Conjugate vaccine when given alone compared to when given concomitantly with tetanus,&#xD;
      diphtheria, acellular pertussis (Tdap) vaccine and human papilloma virus (HPV) vaccine.&#xD;
&#xD;
      Primary objective:&#xD;
&#xD;
        -  To evaluate the antibody responses to the antigens present in MenACYW Conjugate vaccine&#xD;
           when MenACYW Conjugate vaccine was given alone compared to those when MENVEO vaccine was&#xD;
           given alone.&#xD;
&#xD;
      Secondary objective:&#xD;
&#xD;
        -  To evaluate the antibody responses to the antigens present in MenACYW Conjugate vaccine,&#xD;
           when MenACYW Conjugate vaccine was given concomitantly with Tdap and HPV vaccines,&#xD;
           compared to those when it was given alone.&#xD;
&#xD;
        -  To evaluate the antibody responses to the antigens present in Tdap vaccine, when Tdap&#xD;
           vaccine was given concomitantly with MenACYW Conjugate vaccine and HPV vaccine, compared&#xD;
           to those when Tdap vaccine was given with HPV vaccine only.&#xD;
&#xD;
        -  To evaluate the antibody responses to the antigens present in HPV vaccine after the&#xD;
           3-dose series, when the first dose of HPV vaccine is given concomitantly with MenACYW&#xD;
           Conjugate vaccine and Tdap vaccine, compared to those when the first dose of HPV vaccine&#xD;
           is given with Tdap vaccine only.&#xD;
&#xD;
      Observational objective:&#xD;
&#xD;
        -  To describe the safety profile of MenACYW Conjugate vaccine, compared to that of the&#xD;
           licensed vaccine MENVEO®, and when MenACYW Conjugate vaccine was given with Tdap and HPV&#xD;
           vaccines.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Healthy adolescents were randomized and received a single dose of their assigned vaccines.&#xD;
      They were assessed for immunogenicity at baseline (pre-vaccination) and at 30 days&#xD;
      post-vaccination. Safety information were collected post-vaccination and throughout the&#xD;
      entire study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 22, 2014</start_date>
  <completion_date type="Actual">October 2, 2015</completion_date>
  <primary_completion_date type="Actual">October 2, 2015</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Achieving Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine</measure>
    <time_frame>Day 30 (post-vaccination)</time_frame>
    <description>Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA. The hSBA vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers greater than or equal to (&gt;=) 1:8 for participants with pre-vaccination hSBA titers less than (&lt;) 1:8 or at least a 4-fold increase in hSBA titers from pre- to post vaccination for participants with pre-vaccination hSBA titers &gt;= 1:8. Data for this outcome measure was not planned to be collected and analyzed for Group 4:Tdap+HPV.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving hSBA Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MenACYW Conjugate Vaccine Given With Tdap and HPV Vaccines</measure>
    <time_frame>Day 30 (post-vaccination on Day 0)</time_frame>
    <description>Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA. The hSBA vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers &gt;= 1:8 for participants with pre-vaccination hSBA titers &lt; 1:8 or at least a 4-fold increase in hSBA titers from pre- to post vaccination for participants with pre-vaccination hSBA titers &gt;= 1:8.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Concentrations (GMCs) of PT, FHA, PRN, and FIM Antibodies Following Vaccination With Either MenACYW Conjugate Vaccine Given With Tdap and HPV Vaccines or Tdap and HPV Vaccines</measure>
    <time_frame>Day 30 (post-vaccination on Day 0)</time_frame>
    <description>Anti-Pertussis toxoid (PT), Filamentous hemagglutinin (FHA), Pertactin (PRN), and Fimbriae types 2 and 3 (FIM) antibodies were measured by enzyme-linked immunosorbent assay (ELISA).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Anti-Tetanus and Anti-Diphtheria Concentrations &gt;= 1.0 International Unit (IU)/mL Following Vaccination With Either MenACYW Conjugate Vaccine Given With Tdap and HPV Vaccines or Tdap and HPV Vaccines</measure>
    <time_frame>Day 30 (post-vaccination on Day 0)</time_frame>
    <description>Anti-Diphtheria antibodies were measured by a toxin neutralization test. Anti-Tetanus antibodies were measured by ELISA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Seroconversion for Anti-HPV6, HPV11, HPV16, and HPV18 Antibodies Following Vaccination With Either MenACYW Conjugate Vaccine Given With Tdap and HPV Vaccines or Tdap and HPV Vaccines</measure>
    <time_frame>Day 210 (post-vaccination on Day 0)</time_frame>
    <description>Anti-HPV 6, 11, 16, and 18 antibodies were measured using a competitive Luminex immunoassay. Seroconversion was defined as changing serostatus from seronegative to seropositive. Cutoff values for HPV seropositivity were &gt;= 20 milli-Merck units per milliliter (mMU/mL) for types 6 and 16, &gt;= 16 mMU/mL for type 11, and &gt;= 24mMU/mL for type 18.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Vaccination With MenACYW Conjugate Vaccine or MENVEO® Vaccine at Day 0: Group 1 and Group 2</measure>
    <time_frame>Within 7 days after vaccines injections at Day 0</time_frame>
    <description>A Solicited Reaction (SR) was an Adverse Event (AE) that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). Solicited injection site reactions included: Pain, Erythema, and Swelling.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Vaccination With MenACYW Conjugate Vaccine Given With Tdap and HPV Vaccines at Day 0: Group 3</measure>
    <time_frame>Within 7 days after vaccines injections at Day 0</time_frame>
    <description>A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). Solicited injection site reactions included: Pain, Erythema, and Swelling.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Vaccination With Tdap and HPV Vaccines at Day 0: Group 4</measure>
    <time_frame>Within 7 days after vaccines injections at Day 0</time_frame>
    <description>A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). Solicited injection site reactions included: Pain, Erythema, and Swelling.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">1715</enrollment>
  <condition>Meningitis</condition>
  <condition>Meningococcal Meningitis</condition>
  <condition>Meningococcal Infections</condition>
  <arm_group>
    <arm_group_label>Group 1: MenACYW Conjugate Vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MenACYW Conjugate vaccine on Day 0.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2: MENVEO® Vaccine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MENVEO® vaccine on Day 0.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3: MenACYW Conjugate Vaccine+Tdap+HPV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MenACYW Conjugate vaccine, Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap), and Dose 1 of HPV Vaccine on Day 0. HPV Vaccine Dose 2 and Dose 3 were given at 2 and 6 months, respectively, after Dose 1 given on Day 0.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 4: Tdap+HPV</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of Tdap and Dose 1 of HPV Vaccine on Day 0. HPV Vaccine Dose 2 and Dose 3 were given at 2 and 6 months, respectively, after Dose 1 given on Day 0.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Meningococcal Polysaccharide (Serogroups A, C, Y, and W135) Tetanus Toxoid Conjugate Vaccine</intervention_name>
    <description>0.5 milliliter (mL), Intramuscular (IM)</description>
    <arm_group_label>Group 1: MenACYW Conjugate Vaccine</arm_group_label>
    <other_name>MenACYW Conjugate vaccine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Meningococcal (Groups A, C, Y and W135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine</intervention_name>
    <description>0.5 mL, IM</description>
    <arm_group_label>Group 2: MENVEO® Vaccine</arm_group_label>
    <other_name>MENVEO®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed</intervention_name>
    <description>0.5 mL, IM</description>
    <arm_group_label>Group 3: MenACYW Conjugate Vaccine+Tdap+HPV</arm_group_label>
    <other_name>Adacel® (Tdap)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>GARDASIL®: Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant</intervention_name>
    <description>0.5 mL, IM</description>
    <arm_group_label>Group 3: MenACYW Conjugate Vaccine+Tdap+HPV</arm_group_label>
    <other_name>GARDASIL® (HPV)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Meningococcal Polysaccharide (Serogroups A, C, Y, and W135) Tetanus Toxoid Conjugate Vaccine</intervention_name>
    <description>0.5 mL, Intramuscular (IM)</description>
    <arm_group_label>Group 3: MenACYW Conjugate Vaccine+Tdap+HPV</arm_group_label>
    <other_name>MenACYW Conjugate vaccine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed</intervention_name>
    <description>0.5 mL, IM</description>
    <arm_group_label>Group 4: Tdap+HPV</arm_group_label>
    <other_name>Adacel® (Tdap)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>GARDASIL®: Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant</intervention_name>
    <description>0.5 mL, IM</description>
    <arm_group_label>Group 4: Tdap+HPV</arm_group_label>
    <other_name>GARDASIL® (HPV)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 10 to 17 years on the day of inclusion.&#xD;
&#xD;
          -  Informed consent form was signed and dated by the parent(s) or another legally&#xD;
             acceptable representative.&#xD;
&#xD;
          -  Assent form was signed and dated by the participant.&#xD;
&#xD;
          -  Participant and parent legally acceptable representative were able to attend all&#xD;
             scheduled visits and comply with all trial procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participant was pregnant, or lactating, or of childbearing potential (to be considered&#xD;
             of non-childbearing potential, a female must be pre-menarche, surgically sterile, or&#xD;
             using an effective method of contraception or abstinence from at least 4 weeks prior&#xD;
             to the first vaccination and until at least 4 weeks after the last vaccination).&#xD;
&#xD;
          -  Participation in the 4 weeks preceding the first trial vaccination(s) or planned&#xD;
             participation during the present trial period in another clinical trial investigating&#xD;
             a vaccine, drug, medical device, or medical procedure.&#xD;
&#xD;
          -  Receipt of any vaccine in the 4 weeks preceding the first trial vaccination(s) or&#xD;
             planned receipt of any vaccine in the 4 weeks prior to or following any trial&#xD;
             vaccination except for influenza vaccination, which may be received at least 2 weeks&#xD;
             before or after any study vaccines. This exception included monovalent influenza&#xD;
             vaccines and multivalent influenza vaccines.&#xD;
&#xD;
          -  Previous vaccination against meningococcal disease with either the trial vaccine or&#xD;
             any mono- or polyvalent polysaccharide or conjugate meningococcal vaccine containing&#xD;
             A, C, W, or Y antigens.&#xD;
&#xD;
          -  History of vaccination with any tetanus, diphtheria, or pertussis vaccine within the&#xD;
             previous 4 years.&#xD;
&#xD;
          -  Previous human papilloma virus (HPV) vaccination.&#xD;
&#xD;
          -  Receipt of immune globulins, blood or blood-derived products in the past 3 months.&#xD;
&#xD;
          -  Known or suspected congenital or acquired immunodeficiency; or receipt of&#xD;
             immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy,&#xD;
             within the preceding 6 months; or long-term systemic corticosteroid therapy&#xD;
             (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).&#xD;
&#xD;
          -  History of meningococcal infection, confirmed either clinically, serologically, or&#xD;
             microbiologically.&#xD;
&#xD;
          -  At high risk for meningococcal infection during the trial (i.e., participants with&#xD;
             persistent complement deficiency, with anatomic or functional asplenia, or&#xD;
             participants travelling to countries with high endemic or epidemic disease).&#xD;
&#xD;
          -  Known systemic hypersensitivity to any of the vaccine components, or history of a&#xD;
             life-threatening reaction to the vaccines used in the trial or to a vaccine containing&#xD;
             any of the same substances, including encephalopathy (e.g., coma, decreased level of&#xD;
             consciousness, prolonged seizures) within 7 days of administration of a previous&#xD;
             pertussis antigen-containing vaccine.&#xD;
&#xD;
          -  Personal history of Guillain-Barré syndrome.&#xD;
&#xD;
          -  Personal history of an Arthus-like reaction after vaccination with a tetanus&#xD;
             toxoid-containing vaccine within at least 10 years of the proposed study vaccination.&#xD;
&#xD;
          -  Verbal report of thrombocytopenia, contraindicating intramuscular vaccination.&#xD;
&#xD;
          -  Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,&#xD;
             contraindicating intramuscular vaccination.&#xD;
&#xD;
          -  Deprived of freedom by an administrative or court order, or in an emergency setting,&#xD;
             or hospitalized involuntarily.&#xD;
&#xD;
          -  Current alcohol abuse or drug addiction.&#xD;
&#xD;
          -  Chronic illness (e.g., human immunodeficiency virus [HIV] hepatitis B, hepatitis C)&#xD;
             that, in the opinion of the investigator, was at a stage where it might interfere with&#xD;
             trial conduct or completion.&#xD;
&#xD;
          -  Moderate or severe acute illness/infection (according to investigator judgment) on the&#xD;
             day of vaccination or febrile illness (temperature &gt;= 100.4 degree fahrenheit [°F]). A&#xD;
             prospective participant was not included in the study until the condition had resolved&#xD;
             or the febrile event had subsided.&#xD;
&#xD;
          -  Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first&#xD;
             blood draw.&#xD;
&#xD;
          -  Identified as an Investigator or employee of the Investigator or study center with&#xD;
             direct involvement in the proposed study, or identified as an immediate family member&#xD;
             (i.e., natural or adopted child) of the Investigator or employee with direct&#xD;
             involvement in the proposed study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Sanofi Pasteur Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35802</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Downey</city>
        <state>California</state>
        <zip>90241</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Miami Beach</city>
        <state>Florida</state>
        <zip>33141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bardstown</city>
        <state>Kentucky</state>
        <zip>40004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nicholasville</city>
        <state>Kentucky</state>
        <zip>40356</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Columbia</city>
        <state>Maryland</state>
        <zip>21075</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68516</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45414</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Norman</city>
        <state>Oklahoma</state>
        <zip>73069</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Erie</city>
        <state>Pennsylvania</state>
        <zip>16505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29414</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kingsport</city>
        <state>Tennessee</state>
        <zip>37660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tullahoma</city>
        <state>Tennessee</state>
        <zip>37388</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Layton</city>
        <state>Utah</state>
        <zip>84041</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Orem</city>
        <state>Utah</state>
        <zip>84057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Payson</city>
        <state>Utah</state>
        <zip>84651</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Provo</city>
        <state>Utah</state>
        <zip>84064</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Roy</city>
        <state>Utah</state>
        <zip>84067</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>South Jordan</city>
        <state>Utah</state>
        <zip>84095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Spanish Fork</city>
        <state>Utah</state>
        <zip>84660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Syracuse</city>
        <state>Utah</state>
        <zip>84075</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>West Haven</city>
        <state>Utah</state>
        <zip>84401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>West Jordan</city>
        <state>Utah</state>
        <zip>84088</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Midlothian</city>
        <state>Virginia</state>
        <zip>23113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Juan</city>
        <zip>00918</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Puerto Rico</country>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Chang LJ, Hedrick J, Christensen S, Pan J, Jordanov E, Dhingra MS. A Phase II, randomized, immunogenicity and safety study of a quadrivalent meningococcal conjugate vaccine, MenACYW-TT, in healthy adolescents in the United States. Vaccine. 2020 Apr 23;38(19):3560-3569. doi: 10.1016/j.vaccine.2020.03.017. Epub 2020 Mar 21.</citation>
    <PMID>32209248</PMID>
  </results_reference>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>July 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <results_first_submitted>May 19, 2020</results_first_submitted>
  <results_first_submitted_qc>May 19, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">June 9, 2020</results_first_posted>
  <disposition_first_submitted>September 29, 2015</disposition_first_submitted>
  <disposition_first_submitted_qc>September 29, 2015</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">October 20, 2015</disposition_first_posted>
  <last_update_submitted>March 24, 2022</last_update_submitted>
  <last_update_submitted_qc>March 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Meningitis</keyword>
  <keyword>Meningococcal Meningitis</keyword>
  <keyword>MenACYW Conjugate vaccine</keyword>
  <keyword>MENVEO vaccine</keyword>
  <keyword>Adacel®</keyword>
  <keyword>GARDASIL®</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Meningococcal Infections</mesh_term>
    <mesh_term>Meningitis, Meningococcal</mesh_term>
    <mesh_term>Meningitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaccines</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Study participants were enrolled in 40 centers in the Unites States (US) from 22 July 2014 to 25 February 2015.</recruitment_details>
      <pre_assignment_details>A total of 1715 participants were enrolled and randomized in the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Group 1: MenACYW Conjugate Vaccine</title>
          <description>Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine on Day 0.</description>
        </group>
        <group group_id="P2">
          <title>Group 2: MENVEO® Vaccine</title>
          <description>Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MENVEO® vaccine on Day 0.</description>
        </group>
        <group group_id="P3">
          <title>Group 3: MenACYW Conjugate Vaccine+Tdap+HPV</title>
          <description>Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MenACYW Conjugate vaccine, Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap), and Dose 1 of Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant (HPV) on Day 0. HPV Vaccine Dose 2 and Dose 3 were given at 2 and 6 months, respectively, after Dose 1 given on Day 0.</description>
        </group>
        <group group_id="P4">
          <title>Group 4: Tdap+HPV</title>
          <description>Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of Tdap and Dose 1 of HPV on Day 0. HPV Vaccine Dose 2 and Dose 3 were given at 2 and 6 months, respectively, after Dose 1 given on Day 0.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="505"/>
                <participants group_id="P2" count="507"/>
                <participants group_id="P3" count="403"/>
                <participants group_id="P4" count="300"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Analysis Set (SafAS)</title>
              <participants_list>
                <participants group_id="P1" count="503"/>
                <participants group_id="P2" count="501"/>
                <participants group_id="P3" count="392"/>
                <participants group_id="P4" count="296"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="495"/>
                <participants group_id="P2" count="500"/>
                <participants group_id="P3" count="376"/>
                <participants group_id="P4" count="270"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="27"/>
                <participants group_id="P4" count="30"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="12"/>
                <participants group_id="P4" count="13"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Analysis was performed on all randomized participants.</population>
      <group_list>
        <group group_id="B1">
          <title>Group 1: MenACYW Conjugate Vaccine</title>
          <description>Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MenACYW Conjugate vaccine on Day 0.</description>
        </group>
        <group group_id="B2">
          <title>Group 2: MENVEO® Vaccine</title>
          <description>Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MENVEO® vaccine on Day 0.</description>
        </group>
        <group group_id="B3">
          <title>Group 3: MenACYW Conjugate Vaccine+Tdap+HPV</title>
          <description>Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MenACYW Conjugate vaccine, Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap), and Dose 1 of HPV Vaccine on Day 0. HPV Vaccine Dose 2 and Dose 3 were given at 2 and 6 months, respectively, after Dose 1 given on Day 0.</description>
        </group>
        <group group_id="B4">
          <title>Group 4: Tdap+HPV</title>
          <description>Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of Tdap and Dose 1 of HPV Vaccine on Day 0. HPV Vaccine Dose 2 and Dose 3 were given at 2 and 6 months, respectively, after Dose 1 given on Day 0.</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="505"/>
            <count group_id="B2" value="507"/>
            <count group_id="B3" value="403"/>
            <count group_id="B4" value="300"/>
            <count group_id="B5" value="1715"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11.4" spread="1.39"/>
                    <measurement group_id="B2" value="11.4" spread="1.39"/>
                    <measurement group_id="B3" value="11.3" spread="1.06"/>
                    <measurement group_id="B4" value="11.4" spread="1.41"/>
                    <measurement group_id="B5" value="11.4" spread="1.32"/>
                  </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="259"/>
                    <measurement group_id="B2" value="232"/>
                    <measurement group_id="B3" value="197"/>
                    <measurement group_id="B4" value="144"/>
                    <measurement group_id="B5" value="832"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="246"/>
                    <measurement group_id="B2" value="275"/>
                    <measurement group_id="B3" value="206"/>
                    <measurement group_id="B4" value="156"/>
                    <measurement group_id="B5" value="883"/>
                  </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="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="18"/>
                    <measurement group_id="B5" value="85"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="442"/>
                    <measurement group_id="B2" value="456"/>
                    <measurement group_id="B3" value="361"/>
                    <measurement group_id="B4" value="261"/>
                    <measurement group_id="B5" value="1520"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="82"/>
                  </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="2"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="505"/>
                    <measurement group_id="B2" value="507"/>
                    <measurement group_id="B3" value="403"/>
                    <measurement group_id="B4" value="300"/>
                    <measurement group_id="B5" value="1715"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Achieving Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine</title>
        <description>Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA. The hSBA vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers greater than or equal to (&gt;=) 1:8 for participants with pre-vaccination hSBA titers less than (&lt;) 1:8 or at least a 4-fold increase in hSBA titers from pre- to post vaccination for participants with pre-vaccination hSBA titers &gt;= 1:8. Data for this outcome measure was not planned to be collected and analyzed for Group 4:Tdap+HPV.</description>
        <time_frame>Day 30 (post-vaccination)</time_frame>
        <population>Analysis was performed on Per-Protocol Analysis Set-1(PPAS-1) defined for accessing the ACYW &amp; Tdap immune response data for all participants after they had received vaccination(s) at Visit 1(Day 0) &amp; completed blood sampling (BL) at Visit 2(Day 30). Here 'Number analyzed' signifies number of participants with available data for specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: MenACYW Conjugate Vaccine</title>
            <description>Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MenACYW Conjugate vaccine on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: MENVEO® Vaccine</title>
            <description>Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MENVEO® vaccine on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine</title>
          <description>Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA. The hSBA vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers greater than or equal to (&gt;=) 1:8 for participants with pre-vaccination hSBA titers less than (&lt;) 1:8 or at least a 4-fold increase in hSBA titers from pre- to post vaccination for participants with pre-vaccination hSBA titers &gt;= 1:8. Data for this outcome measure was not planned to be collected and analyzed for Group 4:Tdap+HPV.</description>
          <population>Analysis was performed on Per-Protocol Analysis Set-1(PPAS-1) defined for accessing the ACYW &amp; Tdap immune response data for all participants after they had received vaccination(s) at Visit 1(Day 0) &amp; completed blood sampling (BL) at Visit 2(Day 30). Here 'Number analyzed' signifies number of participants with available data for specified category.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="463"/>
                <count group_id="O2" value="464"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serogroup A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="463"/>
                    <count group_id="O2" value="464"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.6" lower_limit="71.4" upper_limit="79.4"/>
                    <measurement group_id="O2" value="66.4" lower_limit="61.9" upper_limit="70.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup C</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="462"/>
                    <count group_id="O2" value="463"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.2" lower_limit="95.2" upper_limit="98.5"/>
                    <measurement group_id="O2" value="72.6" lower_limit="68.3" upper_limit="76.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup Y</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="462"/>
                    <count group_id="O2" value="464"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.0" lower_limit="95.0" upper_limit="98.3"/>
                    <measurement group_id="O2" value="80.8" lower_limit="76.9" upper_limit="84.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup W</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="463"/>
                    <count group_id="O2" value="464"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.2" lower_limit="82.7" upper_limit="89.2"/>
                    <measurement group_id="O2" value="66.6" lower_limit="62.1" upper_limit="70.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup A</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>95% confidence interval (CI) of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was &gt; -10%.</non_inferiority_desc>
            <param_type>Percentage Difference</param_type>
            <param_value>9.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.4</ci_lower_limit>
            <ci_upper_limit>15</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup C</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was &gt; -10%.</non_inferiority_desc>
            <param_type>Percentage Difference</param_type>
            <param_value>24.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>20.3</ci_lower_limit>
            <ci_upper_limit>29</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was &gt; -10%.</non_inferiority_desc>
            <param_type>Percentage Difference</param_type>
            <param_value>16.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>12.3</ci_lower_limit>
            <ci_upper_limit>20.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup W</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was &gt; -10%.</non_inferiority_desc>
            <param_type>Percentage Difference</param_type>
            <param_value>19.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>14.2</ci_lower_limit>
            <ci_upper_limit>24.8</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving hSBA Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MenACYW Conjugate Vaccine Given With Tdap and HPV Vaccines</title>
        <description>Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA. The hSBA vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers &gt;= 1:8 for participants with pre-vaccination hSBA titers &lt; 1:8 or at least a 4-fold increase in hSBA titers from pre- to post vaccination for participants with pre-vaccination hSBA titers &gt;= 1:8.</description>
        <time_frame>Day 30 (post-vaccination on Day 0)</time_frame>
        <population>Analysis was performed on PPAS-1. Here 'Number analyzed' signifies number of participants with available data for specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 4: Tdap+HPV.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: MenACYW Conjugate Vaccine</title>
            <description>Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MenACYW Conjugate vaccine on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Group 3: MenACYW Conjugate Vaccine+Tdap+HPV</title>
            <description>Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MenACYW Conjugate vaccine, Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap), and Dose 1 of HPV Vaccine on Day 0. HPV Vaccine Dose 2 and Dose 3 were given at 2 and 6 months, respectively, after Dose 1 given on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving hSBA Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MenACYW Conjugate Vaccine Given With Tdap and HPV Vaccines</title>
          <description>Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA. The hSBA vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers &gt;= 1:8 for participants with pre-vaccination hSBA titers &lt; 1:8 or at least a 4-fold increase in hSBA titers from pre- to post vaccination for participants with pre-vaccination hSBA titers &gt;= 1:8.</description>
          <population>Analysis was performed on PPAS-1. Here 'Number analyzed' signifies number of participants with available data for specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 4: Tdap+HPV.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="463"/>
                <count group_id="O2" value="360"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serogroup A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="463"/>
                    <count group_id="O2" value="360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.6"/>
                    <measurement group_id="O2" value="80.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup C</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="462"/>
                    <count group_id="O2" value="360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.2"/>
                    <measurement group_id="O2" value="97.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup Y</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="462"/>
                    <count group_id="O2" value="360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.0"/>
                    <measurement group_id="O2" value="95.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serogroup W</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="463"/>
                    <count group_id="O2" value="360"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.2"/>
                    <measurement group_id="O2" value="83.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup A</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was &gt; -10%.</non_inferiority_desc>
            <param_type>Percentage Difference</param_type>
            <param_value>5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.8</ci_lower_limit>
            <ci_upper_limit>10.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup C</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was &gt; -10%.</non_inferiority_desc>
            <param_type>Percentage Difference</param_type>
            <param_value>0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.5</ci_lower_limit>
            <ci_upper_limit>2.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup Y</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was &gt; -10%.</non_inferiority_desc>
            <param_type>Percentage Difference</param_type>
            <param_value>-1.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.3</ci_lower_limit>
            <ci_upper_limit>1.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup W</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was &gt; -10%.</non_inferiority_desc>
            <param_type>Percentage Difference</param_type>
            <param_value>-2.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.3</ci_lower_limit>
            <ci_upper_limit>2.6</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Concentrations (GMCs) of PT, FHA, PRN, and FIM Antibodies Following Vaccination With Either MenACYW Conjugate Vaccine Given With Tdap and HPV Vaccines or Tdap and HPV Vaccines</title>
        <description>Anti-Pertussis toxoid (PT), Filamentous hemagglutinin (FHA), Pertactin (PRN), and Fimbriae types 2 and 3 (FIM) antibodies were measured by enzyme-linked immunosorbent assay (ELISA).</description>
        <time_frame>Day 30 (post-vaccination on Day 0)</time_frame>
        <population>Analysis was performed on PPAS-1. Here 'Number analyzed' signifies number of participants with available data for specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 1: MenACYW Conjugate vaccine and Group 2: MENVEO® vaccine.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 3: MenACYW Conjugate Vaccine+Tdap+HPV</title>
            <description>Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MenACYW Conjugate vaccine, Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap), and Dose 1 of HPV Vaccine on Day 0. HPV Vaccine Dose 2 and Dose 3 were given at 2 and 6 months, respectively, after Dose 1 given on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Group 4: Tdap+HPV</title>
            <description>Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of Tdap and Dose 1 of HPV Vaccine on Day 0. HPV Vaccine Dose 2 and Dose 3 were given at 2 and 6 months, respectively, after Dose 1 given on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Concentrations (GMCs) of PT, FHA, PRN, and FIM Antibodies Following Vaccination With Either MenACYW Conjugate Vaccine Given With Tdap and HPV Vaccines or Tdap and HPV Vaccines</title>
          <description>Anti-Pertussis toxoid (PT), Filamentous hemagglutinin (FHA), Pertactin (PRN), and Fimbriae types 2 and 3 (FIM) antibodies were measured by enzyme-linked immunosorbent assay (ELISA).</description>
          <population>Analysis was performed on PPAS-1. Here 'Number analyzed' signifies number of participants with available data for specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 1: MenACYW Conjugate vaccine and Group 2: MENVEO® vaccine.</population>
          <units>ELISA units (EU)/mL</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="360"/>
                <count group_id="O2" value="263"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Anti-Pertussis toxoid (PT)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="339"/>
                    <count group_id="O2" value="258"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.5" lower_limit="33.8" upper_limit="41.7"/>
                    <measurement group_id="O2" value="44.4" lower_limit="39.5" upper_limit="49.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Filamentous hemagglutinin (FHA)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="358"/>
                    <count group_id="O2" value="263"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="180" lower_limit="168" upper_limit="194"/>
                    <measurement group_id="O2" value="242" lower_limit="218" upper_limit="268"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pertactin (PRN)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="360"/>
                    <count group_id="O2" value="263"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="200" lower_limit="177" upper_limit="225"/>
                    <measurement group_id="O2" value="265" lower_limit="231" upper_limit="304"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fimbriae types 2 and 3 (FIM)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="350"/>
                    <count group_id="O2" value="262"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="339" lower_limit="285" upper_limit="403"/>
                    <measurement group_id="O2" value="499" lower_limit="414" upper_limit="601"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>PT: Geometric Mean Ratio</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio was &gt;2/3.</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>0.845</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.722</ci_lower_limit>
            <ci_upper_limit>0.99</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>FHA: Geometric Mean Ratio</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio was &gt;2/3.</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>0.746</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.661</ci_lower_limit>
            <ci_upper_limit>0.842</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>PRN: Geometric Mean Ratio</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio was &gt;2/3.</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>0.753</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.627</ci_lower_limit>
            <ci_upper_limit>0.903</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>FIM: Geometric Mean Ratio</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio was &gt;2/3.</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>0.679</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.525</ci_lower_limit>
            <ci_upper_limit>0.878</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving Anti-Tetanus and Anti-Diphtheria Concentrations &gt;= 1.0 International Unit (IU)/mL Following Vaccination With Either MenACYW Conjugate Vaccine Given With Tdap and HPV Vaccines or Tdap and HPV Vaccines</title>
        <description>Anti-Diphtheria antibodies were measured by a toxin neutralization test. Anti-Tetanus antibodies were measured by ELISA.</description>
        <time_frame>Day 30 (post-vaccination on Day 0)</time_frame>
        <population>Analysis was performed on PPAS-1. Here &quot;Number analyzed' signifies number of participants with available data for specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 1: MenACYW Conjugate vaccine and Group 2: MENVEO® vaccine.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 3: MenACYW Conjugate Vaccine+Tdap+HPV</title>
            <description>Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MenACYW Conjugate vaccine, Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap), and Dose 1 of HPV Vaccine on Day 0. HPV Vaccine Dose 2 and Dose 3 were given at 2 and 6 months, respectively, after Dose 1 given on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Group 4: Tdap+HPV</title>
            <description>Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of Tdap and Dose 1 of HPV Vaccine on Day 0. HPV Vaccine Dose 2 and Dose 3 were given at 2 and 6 months, respectively, after Dose 1 given on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Anti-Tetanus and Anti-Diphtheria Concentrations &gt;= 1.0 International Unit (IU)/mL Following Vaccination With Either MenACYW Conjugate Vaccine Given With Tdap and HPV Vaccines or Tdap and HPV Vaccines</title>
          <description>Anti-Diphtheria antibodies were measured by a toxin neutralization test. Anti-Tetanus antibodies were measured by ELISA.</description>
          <population>Analysis was performed on PPAS-1. Here &quot;Number analyzed' signifies number of participants with available data for specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 1: MenACYW Conjugate vaccine and Group 2: MENVEO® vaccine.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="360"/>
                <count group_id="O2" value="263"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Diphtheria</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="360"/>
                    <count group_id="O2" value="263"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.8" lower_limit="95.7" upper_limit="99.0"/>
                    <measurement group_id="O2" value="98.9" lower_limit="96.7" upper_limit="99.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tetanus</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="360"/>
                    <count group_id="O2" value="262"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.7" lower_limit="98.5" upper_limit="100.0"/>
                    <measurement group_id="O2" value="99.6" lower_limit="97.9" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup Diphtheria</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was &gt;-10%.</non_inferiority_desc>
            <param_type>Percentage Difference</param_type>
            <param_value>-1.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.3</ci_lower_limit>
            <ci_upper_limit>1.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serogroup Tetanus</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was &gt;-10%.</non_inferiority_desc>
            <param_type>Percentage Difference</param_type>
            <param_value>0.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.2</ci_lower_limit>
            <ci_upper_limit>1.9</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving Seroconversion for Anti-HPV6, HPV11, HPV16, and HPV18 Antibodies Following Vaccination With Either MenACYW Conjugate Vaccine Given With Tdap and HPV Vaccines or Tdap and HPV Vaccines</title>
        <description>Anti-HPV 6, 11, 16, and 18 antibodies were measured using a competitive Luminex immunoassay. Seroconversion was defined as changing serostatus from seronegative to seropositive. Cutoff values for HPV seropositivity were &gt;= 20 milli-Merck units per milliliter (mMU/mL) for types 6 and 16, &gt;= 16 mMU/mL for type 11, and &gt;= 24mMU/mL for type 18.</description>
        <time_frame>Day 210 (post-vaccination on Day 0)</time_frame>
        <population>Per-Protocol Analysis Set-2(PPAS-2)defined for accessing HPV immune response data for participants in Group 3 &amp; 4 after they received third HPV vaccination at Visit 4(Day 180)&amp; completed blood sample at Visit 5(BL3 [Day 210]).Data for this outcome measure was not planned to be collected and analyzed for Groups 1 and 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 3: MenACYW Conjugate Vaccine+Tdap+HPV</title>
            <description>Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MenACYW Conjugate vaccine, Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap), and Dose 1 of HPV Vaccine on Day 0. HPV Vaccine Dose 2 and Dose 3 were given at 2 and 6 months, respectively, after Dose 1 given on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Group 4: Tdap+HPV</title>
            <description>Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of Tdap and Dose 1 of HPV Vaccine on Day 0. HPV Vaccine Dose 2 and Dose 3 were given at 2 and 6 months, respectively, after Dose 1 given on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Seroconversion for Anti-HPV6, HPV11, HPV16, and HPV18 Antibodies Following Vaccination With Either MenACYW Conjugate Vaccine Given With Tdap and HPV Vaccines or Tdap and HPV Vaccines</title>
          <description>Anti-HPV 6, 11, 16, and 18 antibodies were measured using a competitive Luminex immunoassay. Seroconversion was defined as changing serostatus from seronegative to seropositive. Cutoff values for HPV seropositivity were &gt;= 20 milli-Merck units per milliliter (mMU/mL) for types 6 and 16, &gt;= 16 mMU/mL for type 11, and &gt;= 24mMU/mL for type 18.</description>
          <population>Per-Protocol Analysis Set-2(PPAS-2)defined for accessing HPV immune response data for participants in Group 3 &amp; 4 after they received third HPV vaccination at Visit 4(Day 180)&amp; completed blood sample at Visit 5(BL3 [Day 210]).Data for this outcome measure was not planned to be collected and analyzed for Groups 1 and 2.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="242"/>
                <count group_id="O2" value="164"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>HPV Type 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.5" lower_limit="94.7" upper_limit="99.1"/>
                    <measurement group_id="O2" value="95.7" lower_limit="91.4" upper_limit="98.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HPV Type 11</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.6" lower_limit="97.7" upper_limit="100.0"/>
                    <measurement group_id="O2" value="98.8" lower_limit="95.7" upper_limit="99.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HPV Type 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.2" lower_limit="97.0" upper_limit="99.9"/>
                    <measurement group_id="O2" value="98.8" lower_limit="95.7" upper_limit="99.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HPV Type 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.2" lower_limit="97.0" upper_limit="99.9"/>
                    <measurement group_id="O2" value="98.8" lower_limit="95.7" upper_limit="99.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>HPV Type 6</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was &gt;-10%.</non_inferiority_desc>
            <param_type>Percentage Difference</param_type>
            <param_value>1.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.8</ci_lower_limit>
            <ci_upper_limit>6.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>HPV Type 11</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was &gt;-10%.</non_inferiority_desc>
            <param_type>Percentage Difference</param_type>
            <param_value>0.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.3</ci_lower_limit>
            <ci_upper_limit>3.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>HPV Type 16</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was &gt;-10%.</non_inferiority_desc>
            <param_type>Percentage Difference</param_type>
            <param_value>0.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.9</ci_lower_limit>
            <ci_upper_limit>3.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>HPV Type 18</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was &gt;-10%.</non_inferiority_desc>
            <param_type>Percentage Difference</param_type>
            <param_value>0.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.9</ci_lower_limit>
            <ci_upper_limit>3.6</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Vaccination With MenACYW Conjugate Vaccine or MENVEO® Vaccine at Day 0: Group 1 and Group 2</title>
        <description>A Solicited Reaction (SR) was an Adverse Event (AE) that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). Solicited injection site reactions included: Pain, Erythema, and Swelling.</description>
        <time_frame>Within 7 days after vaccines injections at Day 0</time_frame>
        <population>Analysis was performed on Safety Analysis Set (SafAS) defined as participants who received at least one dose of the study vaccine(s) and had any safety data available. All participants had their safety data analyzed according to vaccine(s) they actually received. Here, 'Number analyzed'=participants with available data for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: MenACYW Conjugate Vaccine</title>
            <description>Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MenACYW Conjugate vaccine on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: MENVEO® Vaccine</title>
            <description>Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MENVEO® vaccine on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Vaccination With MenACYW Conjugate Vaccine or MENVEO® Vaccine at Day 0: Group 1 and Group 2</title>
          <description>A Solicited Reaction (SR) was an Adverse Event (AE) that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). Solicited injection site reactions included: Pain, Erythema, and Swelling.</description>
          <population>Analysis was performed on Safety Analysis Set (SafAS) defined as participants who received at least one dose of the study vaccine(s) and had any safety data available. All participants had their safety data analyzed according to vaccine(s) they actually received. Here, 'Number analyzed'=participants with available data for each specified category.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="503"/>
                <count group_id="O2" value="501"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="496"/>
                    <count group_id="O2" value="492"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="224"/>
                    <measurement group_id="O2" value="209"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="496"/>
                    <count group_id="O2" value="491"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="496"/>
                    <count group_id="O2" value="491"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Vaccination With MenACYW Conjugate Vaccine Given With Tdap and HPV Vaccines at Day 0: Group 3</title>
        <description>A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). Solicited injection site reactions included: Pain, Erythema, and Swelling.</description>
        <time_frame>Within 7 days after vaccines injections at Day 0</time_frame>
        <population>Analysis was performed on SafAS. Here &quot;Overall number of participants analyzed&quot; = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 3: MenACYW Conjugate Vaccine+Tdap+HPV</title>
            <description>Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MenACYW Conjugate vaccine, Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap), and Dose 1 of HPV Vaccine on Day 0. HPV Vaccine Dose 2 and Dose 3 were given at 2 and 6 months, respectively, after Dose 1 given on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Vaccination With MenACYW Conjugate Vaccine Given With Tdap and HPV Vaccines at Day 0: Group 3</title>
          <description>A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). Solicited injection site reactions included: Pain, Erythema, and Swelling.</description>
          <population>Analysis was performed on SafAS. Here &quot;Overall number of participants analyzed&quot; = participants evaluable for this outcome measure.</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="388"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>MenACYW site: Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="183"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MenACYW site: Erythema</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MenACYW site: Swelling</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tdap site: Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="286"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tdap site: Erythema</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tdap site: Swelling</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HPV site: Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="288"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HPV site: Erythema</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HPV site: Swelling</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Vaccination With Tdap and HPV Vaccines at Day 0: Group 4</title>
        <description>A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). Solicited injection site reactions included: Pain, Erythema, and Swelling.</description>
        <time_frame>Within 7 days after vaccines injections at Day 0</time_frame>
        <population>Analysis was performed on SafAS. Here &quot;Overall number of participants analyzed&quot; = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 4: Tdap+HPV</title>
            <description>Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of Tdap and Dose 1 of HPV Vaccine on Day 0. HPV Vaccine Dose 2 and Dose 3 were given at 2 and 6 months, respectively, after Dose 1 given on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Vaccination With Tdap and HPV Vaccines at Day 0: Group 4</title>
          <description>A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). Solicited injection site reactions included: Pain, Erythema, and Swelling.</description>
          <population>Analysis was performed on SafAS. Here &quot;Overall number of participants analyzed&quot; = participants evaluable for this outcome measure.</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="289"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Tdap site: Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="211"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tdap site: Erythema</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tdap site: Swelling</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HPV site: Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="201"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HPV site: Erythema</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HPV site: Swelling</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after last vaccination. SR data were collected within 7 days after any vaccination. Serious adverse events (SAEs) data were collected throughout the study (up to 180 days after vaccination for Group 1 and 2, and up to 210 days after vaccination on Day 0 for Group 3 and 4).</time_frame>
      <desc>Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.</desc>
      <group_list>
        <group group_id="E1">
          <title>Group 1: MenACYW Conjugate Vaccine</title>
          <description>Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MenACYW Conjugate vaccine on Day 0.</description>
        </group>
        <group group_id="E2">
          <title>Group 2: MENVEO® Vaccine</title>
          <description>Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MENVEO® vaccine on Day 0.</description>
        </group>
        <group group_id="E3">
          <title>Group 3: MenACYW Conjugate Vaccine+Tdap+HPV</title>
          <description>Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MenACYW Conjugate vaccine, Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap), and Dose 1 of HPV Vaccine on Day 0. HPV Vaccine Dose 2 and Dose 3 were given at 2 and 6 months, respectively, after Dose 1 given on Day 0.</description>
        </group>
        <group group_id="E4">
          <title>Group 4: Tdap+HPV</title>
          <description>Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of Tdap and Dose 1 of HPV Vaccine on Day 0. HPV Vaccine Dose 2 and Dose 3 were given at 2 and 6 months, respectively, after Dose 1 given on Day 0.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 16.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="503"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="501"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="392"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="296"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="503"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="501"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="392"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="296"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="503"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="501"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="392"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="296"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Faecaloma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="503"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="501"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="392"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="296"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Mucosal Inflammation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="503"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="501"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="392"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="296"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="503"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="501"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="392"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="296"/>
              </event>
              <event>
                <sub_title>Staphylococcal Scalded Skin Syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="503"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="501"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="392"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="296"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Type 1 Diabetes Mellitus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="503"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="501"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="392"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="296"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Convulsion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="503"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="501"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="392"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="296"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Abnormal Behaviour</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="503"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="501"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="392"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="296"/>
              </event>
              <event>
                <sub_title>Major Depression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="503"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="501"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="392"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="296"/>
              </event>
              <event>
                <sub_title>Suicidal Ideation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="503"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="501"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="392"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="296"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="503"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="501"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="392"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="296"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Erythema Multiforme</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="503"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="501"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="392"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="296"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 16.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="331" subjects_at_risk="503"/>
                <counts group_id="E2" subjects_affected="337" subjects_at_risk="501"/>
                <counts group_id="E3" subjects_affected="348" subjects_at_risk="392"/>
                <counts group_id="E4" subjects_affected="263" subjects_at_risk="296"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection Site Erythema</sub_title>
                <counts group_id="E1" events="25" subjects_affected="25" subjects_at_risk="503"/>
                <counts group_id="E2" events="37" subjects_affected="37" subjects_at_risk="501"/>
                <counts group_id="E3" events="74" subjects_affected="44" subjects_at_risk="392"/>
                <counts group_id="E4" events="30" subjects_affected="24" subjects_at_risk="296"/>
              </event>
              <event>
                <sub_title>Injection Site Pain</sub_title>
                <counts group_id="E1" events="224" subjects_affected="224" subjects_at_risk="503"/>
                <counts group_id="E2" events="209" subjects_affected="209" subjects_at_risk="501"/>
                <counts group_id="E3" events="759" subjects_affected="327" subjects_at_risk="392"/>
                <counts group_id="E4" events="412" subjects_affected="234" subjects_at_risk="296"/>
              </event>
              <event>
                <sub_title>Injection Site Swelling</sub_title>
                <counts group_id="E1" events="27" subjects_affected="27" subjects_at_risk="503"/>
                <counts group_id="E2" events="32" subjects_affected="32" subjects_at_risk="501"/>
                <counts group_id="E3" events="67" subjects_affected="42" subjects_at_risk="392"/>
                <counts group_id="E4" events="43" subjects_affected="32" subjects_at_risk="296"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="130" subjects_affected="130" subjects_at_risk="503"/>
                <counts group_id="E2" events="131" subjects_affected="131" subjects_at_risk="501"/>
                <counts group_id="E3" events="113" subjects_affected="113" subjects_at_risk="392"/>
                <counts group_id="E4" events="81" subjects_affected="81" subjects_at_risk="296"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="15" subjects_affected="15" subjects_at_risk="503"/>
                <counts group_id="E2" events="34" subjects_affected="32" subjects_at_risk="501"/>
                <counts group_id="E3" events="22" subjects_affected="22" subjects_at_risk="392"/>
                <counts group_id="E4" events="16" subjects_affected="14" subjects_at_risk="296"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" events="27" subjects_affected="24" subjects_at_risk="503"/>
                <counts group_id="E2" events="33" subjects_affected="30" subjects_at_risk="501"/>
                <counts group_id="E3" events="31" subjects_affected="27" subjects_at_risk="392"/>
                <counts group_id="E4" events="13" subjects_affected="12" subjects_at_risk="296"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="175" subjects_affected="175" subjects_at_risk="503"/>
                <counts group_id="E2" events="173" subjects_affected="173" subjects_at_risk="501"/>
                <counts group_id="E3" events="239" subjects_affected="239" subjects_at_risk="392"/>
                <counts group_id="E4" events="161" subjects_affected="161" subjects_at_risk="296"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="165" subjects_affected="155" subjects_at_risk="503"/>
                <counts group_id="E2" events="168" subjects_affected="159" subjects_at_risk="501"/>
                <counts group_id="E3" events="145" subjects_affected="137" subjects_at_risk="392"/>
                <counts group_id="E4" events="89" subjects_affected="87" subjects_at_risk="296"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable participant matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Trial Transparency Team</name_or_title>
      <organization>Sanofi Pasteur</organization>
      <phone>800-633-1610 ext 1#</phone>
      <email>Contact-US@sanofi.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02199691
org study id: MET50
secondary id: U1111-1143-8537
nct id: NCT02199691
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of the study was to evaluate the immunogenicity and describe the safety of
      Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate
      vaccine compared to the licensed vaccine MENVEO® in adolescents 10 to 17 years of age in the
      United States (US). This study also evaluated the immunogenicity and safety of MenACYW
      Conjugate vaccine when given alone compared to when given concomitantly with tetanus,
      diphtheria, acellular pertussis (Tdap) vaccine and human papilloma virus (HPV) vaccine.

      Primary objective:

        -  To evaluate the antibody responses to the antigens present in MenACYW Conjugate vaccine
           when MenACYW Conjugate vaccine was given alone compared to those when MENVEO vaccine was
           given alone.

      Secondary objective:

        -  To evaluate the antibody responses to the antigens present in MenACYW Conjugate vaccine,
           when MenACYW Conjugate vaccine was given concomitantly with Tdap and HPV vaccines,
           compared to those when it was given alone.

        -  To evaluate the antibody responses to the antigens present in Tdap vaccine, when Tdap
           vaccine was given concomitantly with MenACYW Conjugate vaccine and HPV vaccine, compared
           to those when Tdap vaccine was given with HPV vaccine only.

        -  To evaluate the antibody responses to the antigens present in HPV vaccine after the
           3-dose series, when the first dose of HPV vaccine is given concomitantly with MenACYW
           Conjugate vaccine and Tdap vaccine, compared to those when the first dose of HPV vaccine
           is given with Tdap vaccine only.

      Observational objective:

        -  To describe the safety profile of MenACYW Conjugate vaccine, compared to that of the
           licensed vaccine MENVEO®, and when MenACYW Conjugate vaccine was given with Tdap and HPV
           vaccines.
Healthy adolescents were randomized and received a single dose of their assigned vaccines.
      They were assessed for immunogenicity at baseline (pre-vaccination) and at 30 days
      post-vaccination. Safety information were collected post-vaccination and throughout the
      entire study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Percentage of Participants Achieving Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine
time frame: Day 30 (post-vaccination)
description: Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA. The hSBA vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers greater than or equal to (>=) 1:8 for participants with pre-vaccination hSBA titers less than (<) 1:8 or at least a 4-fold increase in hSBA titers from pre- to post vaccination for participants with pre-vaccination hSBA titers >= 1:8. Data for this outcome measure was not planned to be collected and analyzed for Group 4:Tdap+HPV.
measure: Percentage of Participants Achieving hSBA Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MenACYW Conjugate Vaccine Given With Tdap and HPV Vaccines
time frame: Day 30 (post-vaccination on Day 0)
description: Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA. The hSBA vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers >= 1:8 for participants with pre-vaccination hSBA titers < 1:8 or at least a 4-fold increase in hSBA titers from pre- to post vaccination for participants with pre-vaccination hSBA titers >= 1:8.
measure: Geometric Mean Concentrations (GMCs) of PT, FHA, PRN, and FIM Antibodies Following Vaccination With Either MenACYW Conjugate Vaccine Given With Tdap and HPV Vaccines or Tdap and HPV Vaccines
time frame: Day 30 (post-vaccination on Day 0)
description: Anti-Pertussis toxoid (PT), Filamentous hemagglutinin (FHA), Pertactin (PRN), and Fimbriae types 2 and 3 (FIM) antibodies were measured by enzyme-linked immunosorbent assay (ELISA).
measure: Percentage of Participants Achieving Anti-Tetanus and Anti-Diphtheria Concentrations >= 1.0 International Unit (IU)/mL Following Vaccination With Either MenACYW Conjugate Vaccine Given With Tdap and HPV Vaccines or Tdap and HPV Vaccines
time frame: Day 30 (post-vaccination on Day 0)
description: Anti-Diphtheria antibodies were measured by a toxin neutralization test. Anti-Tetanus antibodies were measured by ELISA.
measure: Percentage of Participants Achieving Seroconversion for Anti-HPV6, HPV11, HPV16, and HPV18 Antibodies Following Vaccination With Either MenACYW Conjugate Vaccine Given With Tdap and HPV Vaccines or Tdap and HPV Vaccines
time frame: Day 210 (post-vaccination on Day 0)
description: Anti-HPV 6, 11, 16, and 18 antibodies were measured using a competitive Luminex immunoassay. Seroconversion was defined as changing serostatus from seronegative to seropositive. Cutoff values for HPV seropositivity were >= 20 milli-Merck units per milliliter (mMU/mL) for types 6 and 16, >= 16 mMU/mL for type 11, and >= 24mMU/mL for type 18.
measure: Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Vaccination With MenACYW Conjugate Vaccine or MENVEO® Vaccine at Day 0: Group 1 and Group 2
time frame: Within 7 days after vaccines injections at Day 0
description: A Solicited Reaction (SR) was an Adverse Event (AE) that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). Solicited injection site reactions included: Pain, Erythema, and Swelling.
measure: Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Vaccination With MenACYW Conjugate Vaccine Given With Tdap and HPV Vaccines at Day 0: Group 3
time frame: Within 7 days after vaccines injections at Day 0
description: A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). Solicited injection site reactions included: Pain, Erythema, and Swelling.
measure: Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Vaccination With Tdap and HPV Vaccines at Day 0: Group 4
time frame: Within 7 days after vaccines injections at Day 0
description: A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). Solicited injection site reactions included: Pain, Erythema, and Swelling.
arm group label: Group 1: MenACYW Conjugate Vaccine
arm group type: Experimental
description: Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MenACYW Conjugate vaccine on Day 0.
arm group label: Group 2: MENVEO® Vaccine
arm group type: Active Comparator
description: Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MENVEO® vaccine on Day 0.
arm group label: Group 3: MenACYW Conjugate Vaccine+Tdap+HPV
arm group type: Experimental
description: Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MenACYW Conjugate vaccine, Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap), and Dose 1 of HPV Vaccine on Day 0. HPV Vaccine Dose 2 and Dose 3 were given at 2 and 6 months, respectively, after Dose 1 given on Day 0.
arm group label: Group 4: Tdap+HPV
arm group type: Active Comparator
description: Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of Tdap and Dose 1 of HPV Vaccine on Day 0. HPV Vaccine Dose 2 and Dose 3 were given at 2 and 6 months, respectively, after Dose 1 given on Day 0.
intervention type: Biological
intervention name: Meningococcal Polysaccharide (Serogroups A, C, Y, and W135) Tetanus Toxoid Conjugate Vaccine
description: 0.5 milliliter (mL), Intramuscular (IM)
arm group label: Group 1: MenACYW Conjugate Vaccine
other name: MenACYW Conjugate vaccine
intervention type: Biological
intervention name: Meningococcal (Groups A, C, Y and W135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine
description: 0.5 mL, IM
arm group label: Group 2: MENVEO® Vaccine
other name: MENVEO®
intervention type: Biological
intervention name: Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed
description: 0.5 mL, IM
arm group label: Group 3: MenACYW Conjugate Vaccine+Tdap+HPV
other name: Adacel® (Tdap)
intervention type: Biological
intervention name: GARDASIL®: Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant
description: 0.5 mL, IM
arm group label: Group 3: MenACYW Conjugate Vaccine+Tdap+HPV
other name: GARDASIL® (HPV)
intervention type: Biological
intervention name: Meningococcal Polysaccharide (Serogroups A, C, Y, and W135) Tetanus Toxoid Conjugate Vaccine
description: 0.5 mL, Intramuscular (IM)
arm group label: Group 3: MenACYW Conjugate Vaccine+Tdap+HPV
other name: MenACYW Conjugate vaccine
intervention type: Biological
intervention name: Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed
description: 0.5 mL, IM
arm group label: Group 4: Tdap+HPV
other name: Adacel® (Tdap)
intervention type: Biological
intervention name: GARDASIL®: Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant
description: 0.5 mL, IM
arm group label: Group 4: Tdap+HPV
other name: GARDASIL® (HPV)
criteria: 
gender: All
minimum age: 10 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Medical Director
role: Study Director
affiliation: Sanofi Pasteur Inc.
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country: Puerto Rico
country: United States
citation: Chang LJ, Hedrick J, Christensen S, Pan J, Jordanov E, Dhingra MS. A Phase II, randomized, immunogenicity and safety study of a quadrivalent meningococcal conjugate vaccine, MenACYW-TT, in healthy adolescents in the United States. Vaccine. 2020 Apr 23;38(19):3560-3569. doi: 10.1016/j.vaccine.2020.03.017. Epub 2020 Mar 21.
PMID: 32209248
responsible party type: Sponsor
mesh term: Meningococcal Infections
mesh term: Meningitis, Meningococcal
mesh term: Meningitis
mesh term: Vaccines
sharing ipd: Yes
ipd description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 