<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/NCT02979535</url>
  </required_header>
  <id_info>
    <org_study_id>CYD71</org_study_id>
    <secondary_id>U1111-1161-3455</secondary_id>
    <secondary_id>2019-000994-22</secondary_id>
    <nct_id>NCT02979535</nct_id>
  </id_info>
  <brief_title>Immunogenicity and Safety of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Cervarix®</brief_title>
  <official_title>Immunogenicity and Safety of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Cervarix® in Healthy Female Subjects Aged 9 to 14 Years in Mexico</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>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study was to investigate the immunogenicity and safety of CYD dengue vaccine&#xD;
      and Cervarix when administered concomitantly or sequentially in healthy female participants&#xD;
      aged 9-14 years of age.&#xD;
&#xD;
      Primary objectives:&#xD;
&#xD;
        -  To demonstrate that the humoral immune response (in terms of geometric mean titers&#xD;
           [GMTs]) to Cervarix after concomitant administration with the CYD dengue vaccine is&#xD;
           non-inferior to the humoral immune response (in terms of GMTs) after sequential&#xD;
           administration with the CYD dengue vaccine measured 28 days after the last dose of&#xD;
           Cervarix.&#xD;
&#xD;
        -  To demonstrate that the humoral immune response (in terms of GMTs) to the CYD dengue&#xD;
           vaccine after concomitant administration with Cervarix is non-inferior to the humoral&#xD;
           immune response (in terms of GMTs) to the CYD dengue vaccine after sequential&#xD;
           administration with Cervarix measured 28 days after the last dose of the CYD dengue&#xD;
           vaccine.&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
        -  To demonstrate that the humoral immune response (in terms of seroconversion) to Cervarix&#xD;
           after concomitant administration with the CYD dengue vaccine is non-inferior to the&#xD;
           humoral immune response (in terms of seroconversion) to Cervarix sequential&#xD;
           administration with the CYD dengue vaccine measured 28 days after the last dose of&#xD;
           Cervarix.&#xD;
&#xD;
        -  To describe the humoral immune response to Cervarix at baseline and after each dose of&#xD;
           Cervarix in each and any group.&#xD;
&#xD;
        -  To describe the humoral immune response to the CYD dengue vaccine at baseline and after&#xD;
           each dose of the CYD dengue vaccine, in each and any group.&#xD;
&#xD;
        -  To describe the safety of Cervarix and CYD dengue vaccine after each and any dose in&#xD;
           each group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants received 3 doses of the CYD dengue vaccine and 2 doses of Cervarix administered&#xD;
      either concomitantly or sequentially. Due to a protocol amendment, only previously dengue&#xD;
      exposed participants (seropositive for dengue before vaccination) were eligible to complete&#xD;
      the vaccination schedule and be assessed for CYD immunogenicity and human papilloma virus&#xD;
      (HPV) immunogenicity. Dengue unexposed participants (seronegative for dengue before&#xD;
      vaccination) did not receive the third CYD dengue vaccine injection, but were followed for&#xD;
      safety up to 6 months after the last injection.&#xD;
&#xD;
      Safety assessments included solicited reactions within 7 or 14 days after each injection,&#xD;
      unsolicited adverse events within 28 days after each injection, and serious adverse events&#xD;
      during the study period. All participants were included in the assessment of safety up to 6&#xD;
      months after the last injection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 16, 2016</start_date>
  <completion_date type="Actual">March 25, 2019</completion_date>
  <primary_completion_date type="Actual">March 25, 2019</primary_completion_date>
  <phase>Phase 3</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>Geometric Mean Titers (GMTs) Against Each Cervarix Human Papillomavirus (HPV) Antigen (HPV-16 and HPV-18) 28 Days After Last Cervarix Vaccination in the Previously Dengue Seropositive Participants</measure>
    <time_frame>28 days after the last Cervarix vaccination</time_frame>
    <description>GMTs against each Cervarix HPV antigen (HPV-16 and HPV-18) were assessed using an enzyme-linked immunosorbent assay (ELISA) method. Dengue seropositive participants at baseline were defined as those participants with titers greater than or equal to (&gt;=) 10 (1/dilutions [dil]) for at least one serotype with the parental dengue virus strain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>GMTs Against Each Dengue Virus Serotype 28 Days After the Third CYD Dengue Vaccination in the Previously Dengue Seropositive Participants</measure>
    <time_frame>28 days after third CYD dengue vaccination</time_frame>
    <description>The GMTs against each of the four parental dengue virus serotypes (Serotypes 1, 2, 3, and 4) of CYD dengue vaccine were assessed using the 50% plaque reduction neutralization test (PRNT50) assay. Dengue seropositive participants at baseline were defined as those participants with titers &gt;=10 (1/dil) for at least one serotype with the parental dengue virus strain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>GMTs Against Each Cervarix HPV Antigen (HPV-16 and HPV-18) at Day 0 and 28 Days After Each Cervarix Vaccination in the Previously Dengue Seropositive Participants</measure>
    <time_frame>Day 0 and 28 days after each Cervarix vaccination</time_frame>
    <description>The GMTs against each Cervarix HPV antigen (HPV-16 and HPV-18) were assessed using an ELISA method. Dengue seropositive participants at baseline were defined as those participants with titers &gt;=10 (1/dil) for at least one serotype with the parental dengue virus strain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Seroconversion Against Each Cervarix HPV Antigen (HPV-16 and HPV-18) 28 Days After Each Dose of Cervarix Vaccination in the Previously Dengue Seropositive Participants</measure>
    <time_frame>28 days after each Cervarix vaccination</time_frame>
    <description>Neutralizing antibodies against each Cervarix HPV antigen (HPV-16 and HPV-18) were assessed using an ELISA method. Seroconversion was defined as changing serostatus from seronegative at baseline to seropositive (greater than [&gt;] lower limit of quantitation [LLOQ] of the assay) or &gt;=4-fold rise in antibody titer if seropositive at baseline (i.e., at least one antibody levels against Cervarix HPV antigens &gt; LLOQ at baseline). The LLOQ for HPV-16 and HPV-18 was less than (&lt;) 2.0 International Units per milliliter (IU/mL).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants</measure>
    <time_frame>Day 0 and 28 days after each CYD dengue vaccine vaccination</time_frame>
    <description>The GMTs against each of the four parental dengue virus serotypes (Serotypes 1, 2, 3, and 4) of CYD dengue vaccine were assessed using the PRNT50 assay. Dengue seropositive participants at baseline were defined as those participants with titers &gt;=10 (1/dil) for at least one serotype with the parental dengue virus strain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Neutralizing Antibody Titers &gt;=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants</measure>
    <time_frame>Day 0 and 28 days after each CYD dengue vaccine vaccination</time_frame>
    <description>Dengue neutralizing antibody levels against each of the 4 dengue virus serotypes (Serotypes 1, 2, 3, and 4) were measured by PRNT50. Dengue seropositive participants at baseline were defined as those participants with titers &gt;=10 (1/dil) for at least one serotype with the parental dengue virus strain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Neutralizing Antibody Titers &gt;=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants</measure>
    <time_frame>Day 0 and 28 days after each CYD dengue vaccination</time_frame>
    <description>Dengue neutralizing antibody levels against each of the 4 dengue virus serotypes (Serotypes 1, 2, 3, and 4) were measured by PRNT50. Dengue seropositive participants at baseline were defined as those participants with titers &gt;=10 (1/dil) for at least one serotype with the parental dengue virus strain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants</measure>
    <time_frame>Day 0 and 28 days after each CYD dengue vaccination</time_frame>
    <description>Dengue neutralizing antibody levels against each of the 4 dengue virus serotypes (Serotypes 1, 2, 3, and 4) were measured by PRNT50. Dengue seropositive participants at baseline were defined as those participants with titers &gt;=10 (1/dil) for at least one serotype with the parental dengue virus strain. Percentage of participants with neutralizing antibody titers above pre-defined thresholds (&lt;10, &gt;=10 and &gt;=100 [1/dil]) against each dengue virus serotypes of CYD were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Reporting Immediate Adverse Events (AEs) Following Vaccination With Cervarix or CYD Dengue Vaccine</measure>
    <time_frame>Within 30 minutes after each and any vaccination</time_frame>
    <description>Any unsolicited systemic AE occurred during the first 30 minutes post-vaccination was recorded on the case report form (CRF) as immediate AE.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine</measure>
    <time_frame>Up to 7 days after each and any vaccination</time_frame>
    <description>Solicited injection site reactions included pain, erythema, and swelling.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine</measure>
    <time_frame>Up to 14 days after any and each vaccination</time_frame>
    <description>Solicited systemic reactions included Fever, Headache, Malaise, Myalgia, and Asthenia. At Visit 1 and Visit 4, participants from Group 1 received both Cervarix and CYD vaccination and participants from Group 2 received only Cervarix vaccination. At Visit 2 and Visit 5, only participants from Group 2 received CYD vaccination whereas the participants from Group 1 received no vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Reporting Unsolicited AEs Following Vaccination With Cervarix or CYD Dengue Vaccine</measure>
    <time_frame>Up to 28 days after any and each vaccination</time_frame>
    <description>An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the CRF in terms of diagnosis and/or onset post-vaccination. At Visit 1 and Visit 4, participants from Group 1 received both Cervarix and CYD vaccination and participants from Group 2 received only Cervarix vaccination. At Visit 2 and Visit 5, only participants from Group 2 received CYD vaccination whereas the participants from Group 1 received no vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Reporting Non-serious Adverse Event of Special Interests (AESIs) Following Vaccination With Cervarix or CYD Dengue Vaccine</measure>
    <time_frame>Up to 7 days after any and each vaccination</time_frame>
    <description>AESI were AEs that were considered by the Sponsor to be relevant for the monitoring of the safety profile of the investigational vaccine.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Reporting Serious Adverse Events (SAEs) Including Serious AESIs Following Vaccination With Cervarix or CYD Dengue Vaccine</measure>
    <time_frame>From Day 0 up to 6 months after the last CYD or Cervarix vaccination</time_frame>
    <description>An SAEs were AEs resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or a medically important event. An AESIs were AEs that were considered by the Sponsor to be relevant for the monitoring of the safety profile of the investigational vaccine.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Reporting Cases of Virologically Confirmed Dengue (VCD) Hospitalization Following Vaccination With Cervarix or CYD Dengue Vaccine</measure>
    <time_frame>From Day 0 up to 6 months after the last CYD or Cervarix vaccination</time_frame>
    <description>Hospitalized suspected dengue case was defined as an acute febrile illness with diagnosis of dengue requiring hospitalization (with bed attribution). In such cases, 1 unplanned acute blood sample (within the first 5 days after fever onset) was collected for virological confirmation of hospitalized suspected dengue case. A suspected case was considered VCD if there was a detection of wild type dengue virus by dengue non-structural protein 1 antigen ELISA and/or dengue reverse transcriptase-polymerase chain reactions.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">480</enrollment>
  <condition>Dengue Fever</condition>
  <condition>Dengue Hemorrhagic Fever</condition>
  <condition>Human Papillomavirus Disease</condition>
  <arm_group>
    <arm_group_label>CYD Dengue Vaccine + Cervarix (Concomitant Administration)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received 3 doses of CYD dengue vaccine 0.5 milliliter (mL) subcutaneously (SC) at Day 0, Month 6, and Month 12 and 2 doses of Cervarix vaccine 0.5 mL Intramuscularly (IM) concomitantly with the 2 first doses of CYD dengue vaccine.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CYD Dengue Vaccine + Cervarix (Sequential Administration)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Month 1, Month 7, and Month 13 along with the 2 doses of Cervarix vaccine 0.5 mL IM at Day 0 and Month 6 sequentially (i.e., one month before) to each of the 2 first doses of CYD dengue vaccine.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>CYD Dengue Vaccine</intervention_name>
    <description>0.5 mL, SC at Day 0, Months 6 and 12</description>
    <arm_group_label>CYD Dengue Vaccine + Cervarix (Concomitant Administration)</arm_group_label>
    <other_name>Dengvaxia®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>CYD Dengue Vaccine</intervention_name>
    <description>0.5 mL, SC at Months 1, 7, and 13</description>
    <arm_group_label>CYD Dengue Vaccine + Cervarix (Sequential Administration)</arm_group_label>
    <other_name>Dengvaxia®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Human Papillomavirus Bivalent [Types 16 and 18] Vaccine, Recombinant</intervention_name>
    <description>0.5 mL, IM at Day 0 and Month 6</description>
    <arm_group_label>CYD Dengue Vaccine + Cervarix (Concomitant Administration)</arm_group_label>
    <other_name>Cervarix®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Human Papillomavirus Bivalent [Types 16 and 18] Vaccine, Recombinant</intervention_name>
    <description>0.5 mL, IM at Day 0 and Month 6</description>
    <arm_group_label>CYD Dengue Vaccine + Cervarix (Sequential Administration)</arm_group_label>
    <other_name>Cervarix®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female aged 9 to 14 years (i.e., from the day of the 9th birthday to the day prior to&#xD;
             the 15th birthday) on the day of inclusion.&#xD;
&#xD;
          -  Informed consent form (ICF) or Assent form (AF) had been signed and dated by the&#xD;
             participant (based on local regulations), and/or ICF had been signed and dated by the&#xD;
             parent(s) or another legally acceptable representative (and by an independent witness&#xD;
             if required by local regulations).&#xD;
&#xD;
          -  Participant (or participant and parent[s] or another legally acceptable&#xD;
             representative) was (were) able to attend all scheduled visits and complied with all&#xD;
             trial procedures.&#xD;
&#xD;
          -  Participant in good health, based on medical history, and physical examination.&#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 at the time of study enrollment (or in the 4 weeks preceding the first&#xD;
             trial vaccination) or planned participation during the present trial period in another&#xD;
             clinical trial investigating a vaccine, drug, medical device, or medical procedure.&#xD;
&#xD;
          -  Planned receipt of any vaccine in the 4 weeks following any trial vaccination.&#xD;
&#xD;
          -  Previous vaccination against dengue disease with the trial vaccine.&#xD;
&#xD;
          -  Previous vaccination against HPV disease with either the trial vaccine or another&#xD;
             vaccine.&#xD;
&#xD;
          -  Receipt of immune globulins, blood or blood-derived products in the past 3 months.&#xD;
&#xD;
          -  Known or suspected congenital or acquired immunodeficiency (including HIV infection&#xD;
             with impaired immune function); or receipt of immunosuppressive therapy, such as&#xD;
             anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or&#xD;
             long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2&#xD;
             consecutive weeks within the past 3 months).&#xD;
&#xD;
          -  History of HPV infection, confirmed either clinically, serologically, or&#xD;
             microbiologically as reported by participant or parent(s) or another legally&#xD;
             acceptable representative.&#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.&#xD;
&#xD;
          -  Thrombocytopenia, contraindicating IM vaccination.&#xD;
&#xD;
          -  Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,&#xD;
             contraindicating IM vaccination.&#xD;
&#xD;
          -  Deprived of freedom by an administrative or court order, or in an emergency setting,&#xD;
             or hospitalized involuntarily.&#xD;
&#xD;
          -  Current alcohol abuse or drug addiction that, based on investigator's judgment, might&#xD;
             interfere with the participant's ability to comply with trial procedures.&#xD;
&#xD;
          -  Chronic illness that, in the opinion of the Investigator, was at a stage where it&#xD;
             might interfere with trial conduct or completion.&#xD;
&#xD;
          -  Identified as an Investigator or employee of the Investigator with direct involvement&#xD;
             in the proposed study, or identified as an immediate family member (i.e., parent,&#xD;
             spouse, natural or adopted child) of the Investigator or employee with direct&#xD;
             involvement in the proposed study.&#xD;
&#xD;
          -  Self-reported Hepatitis B, Hepatitis C infection.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>14 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 SA</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Mexico City</city>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <results_first_submitted>February 21, 2020</results_first_submitted>
  <results_first_submitted_qc>February 21, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 9, 2020</results_first_posted>
  <last_update_submitted>March 15, 2022</last_update_submitted>
  <last_update_submitted_qc>March 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dengue Fever</keyword>
  <keyword>Dengue Hemorrhagic Fever</keyword>
  <keyword>Human Papillomavirus Disease</keyword>
  <keyword>CYD Dengue Vaccine</keyword>
  <keyword>Dengvaxia®</keyword>
  <keyword>Cervarix®</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dengue</mesh_term>
    <mesh_term>Hemorrhagic Fevers, Viral</mesh_term>
    <mesh_term>Severe Dengue</mesh_term>
    <mesh_term>Fever</mesh_term>
    <mesh_term>Hyperthermia</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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 5, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/35/NCT02979535/Prot_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 21, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/35/NCT02979535/SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Study participants were enrolled from 16 November 2016 to 13 March 2017 at 3 centers in Mexico.</recruitment_details>
      <pre_assignment_details>A total of 480 participants were enrolled and randomized in this study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>CYD Dengue Vaccine + Cervarix (Concomitant Administration)</title>
          <description>Participants received 3 doses of CYD dengue vaccine 0.5 milliliter (mL) subcutaneously (SC) at Day 0, Month 6, and Month 12 and 2 doses of Cervarix vaccine 0.5 mL Intramuscularly (IM) concomitantly with the 2 first doses of CYD dengue vaccine.</description>
        </group>
        <group group_id="P2">
          <title>CYD Dengue Vaccine + Cervarix (Sequential Administration)</title>
          <description>Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Month 1, Month 7, and Month 13 along with the 2 doses of Cervarix vaccine 0.5 mL IM at Day 0 and Month 6 sequentially (i.e., one month before) to each of the 2 first doses of CYD dengue vaccine.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="239"/>
                <participants group_id="P2" count="241"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Analysis Set</title>
              <participants_list>
                <participants group_id="P1" count="237"/>
                <participants group_id="P2" count="241"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="144"/>
                <participants group_id="P2" count="140"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="95"/>
                <participants group_id="P2" count="101"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Non compliance with the protocol</title>
              <participants_list>
                <participants group_id="P1" count="78"/>
                <participants group_id="P2" count="82"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Consent withdrawn by participant</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline characteristics were analyzed on all randomized population which included participants for whom an injection group were allocated.</population>
      <group_list>
        <group group_id="B1">
          <title>CYD Dengue Vaccine + Cervarix (Concomitant Administration)</title>
          <description>Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Day 0, Month 6, and Month 12 and 2 doses of Cervarix vaccine 0.5 mL IM concomitantly with the 2 first doses of CYD dengue vaccine.</description>
        </group>
        <group group_id="B2">
          <title>CYD Dengue Vaccine + Cervarix (Sequential Administration)</title>
          <description>Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Month 1, Month 7, and Month 13 along with the 2 doses of Cervarix vaccine 0.5 mL IM at Day 0 and Month 6 sequentially (i.e., one month before) to each of the 2 first doses of CYD dengue vaccine.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="239"/>
            <count group_id="B2" value="241"/>
            <count group_id="B3" value="480"/>
          </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="9.50" spread="1.00"/>
                    <measurement group_id="B2" value="9.56" spread="1.05"/>
                    <measurement group_id="B3" value="9.53" spread="1.03"/>
                  </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="239"/>
                    <measurement group_id="B2" value="241"/>
                    <measurement group_id="B3" value="480"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race: Not reported</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="239"/>
                    <measurement group_id="B2" value="241"/>
                    <measurement group_id="B3" value="480"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Geometric Mean Titers (GMTs) Against Each Cervarix Human Papillomavirus (HPV) Antigen (HPV-16 and HPV-18) 28 Days After Last Cervarix Vaccination in the Previously Dengue Seropositive Participants</title>
        <description>GMTs against each Cervarix HPV antigen (HPV-16 and HPV-18) were assessed using an enzyme-linked immunosorbent assay (ELISA) method. Dengue seropositive participants at baseline were defined as those participants with titers greater than or equal to (&gt;=) 10 (1/dilutions [dil]) for at least one serotype with the parental dengue virus strain.</description>
        <time_frame>28 days after the last Cervarix vaccination</time_frame>
        <population>Analysis was performed on per-protocol analysis set (PPS) for Cervarix which included participants who received at least one dose of Cervarix vaccine and had no relevant protocol deviations.</population>
        <group_list>
          <group group_id="O1">
            <title>CYD Dengue Vaccine + Cervarix (Concomitant Administration)</title>
            <description>Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Day 0, Month 6, and Month 12 and 2 doses of Cervarix vaccine 0.5 mL IM concomitantly with the 2 first doses of CYD dengue vaccine.</description>
          </group>
          <group group_id="O2">
            <title>CYD Dengue Vaccine + Cervarix (Sequential Administration)</title>
            <description>Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Month 1, Month 7, and Month 13 along with the 2 doses of Cervarix vaccine 0.5 mL IM at Day 0 and Month 6 sequentially (i.e., one month before) to each of the 2 first doses of CYD dengue vaccine.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titers (GMTs) Against Each Cervarix Human Papillomavirus (HPV) Antigen (HPV-16 and HPV-18) 28 Days After Last Cervarix Vaccination in the Previously Dengue Seropositive Participants</title>
          <description>GMTs against each Cervarix HPV antigen (HPV-16 and HPV-18) were assessed using an enzyme-linked immunosorbent assay (ELISA) method. Dengue seropositive participants at baseline were defined as those participants with titers greater than or equal to (&gt;=) 10 (1/dilutions [dil]) for at least one serotype with the parental dengue virus strain.</description>
          <population>Analysis was performed on per-protocol analysis set (PPS) for Cervarix which included participants who received at least one dose of Cervarix vaccine and had no relevant protocol deviations.</population>
          <units>Endotoxin Units per milliliter (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="118"/>
                <count group_id="O2" value="114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>HPV-16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2149" lower_limit="1877" upper_limit="2460"/>
                    <measurement group_id="O2" value="2268" lower_limit="1946" upper_limit="2644"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HPV-18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="833" lower_limit="727" upper_limit="954"/>
                    <measurement group_id="O2" value="845" lower_limit="723" upper_limit="987"/>
                  </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>Antigen HPV-16</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMT ratio</param_type>
            <param_value>0.947</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.773</ci_lower_limit>
            <ci_upper_limit>1.16</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Antigen HPV-18</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMT ratio</param_type>
            <param_value>0.986</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.803</ci_lower_limit>
            <ci_upper_limit>1.21</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>GMTs Against Each Dengue Virus Serotype 28 Days After the Third CYD Dengue Vaccination in the Previously Dengue Seropositive Participants</title>
        <description>The GMTs against each of the four parental dengue virus serotypes (Serotypes 1, 2, 3, and 4) of CYD dengue vaccine were assessed using the 50% plaque reduction neutralization test (PRNT50) assay. Dengue seropositive participants at baseline were defined as those participants with titers &gt;=10 (1/dil) for at least one serotype with the parental dengue virus strain.</description>
        <time_frame>28 days after third CYD dengue vaccination</time_frame>
        <population>Analysis was performed on the full analysis set (FAS) which was defined as the subset of participants who received at least one dose of the study vaccine. Here, &quot;overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>CYD Dengue Vaccine + Cervarix (Concomitant Administration)</title>
            <description>Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Day 0, Month 6, and Month 12 and 2 doses of Cervarix vaccine 0.5 mL IM concomitantly with the 2 first doses of CYD dengue vaccine.</description>
          </group>
          <group group_id="O2">
            <title>CYD Dengue Vaccine + Cervarix (Sequential Administration)</title>
            <description>Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Month 1, Month 7, and Month 13 along with the 2 doses of Cervarix vaccine 0.5 mL IM at Day 0 and Month 6 sequentially (i.e., one month before) to each of the 2 first doses of CYD dengue vaccine.</description>
          </group>
        </group_list>
        <measure>
          <title>GMTs Against Each Dengue Virus Serotype 28 Days After the Third CYD Dengue Vaccination in the Previously Dengue Seropositive Participants</title>
          <description>The GMTs against each of the four parental dengue virus serotypes (Serotypes 1, 2, 3, and 4) of CYD dengue vaccine were assessed using the 50% plaque reduction neutralization test (PRNT50) assay. Dengue seropositive participants at baseline were defined as those participants with titers &gt;=10 (1/dil) for at least one serotype with the parental dengue virus strain.</description>
          <population>Analysis was performed on the full analysis set (FAS) which was defined as the subset of participants who received at least one dose of the study vaccine. Here, &quot;overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>titer (1/dilution)</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="143"/>
                <count group_id="O2" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serotype 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="384" lower_limit="291" upper_limit="507"/>
                    <measurement group_id="O2" value="393" lower_limit="292" upper_limit="528"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="670" lower_limit="535" upper_limit="839"/>
                    <measurement group_id="O2" value="735" lower_limit="575" upper_limit="940"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="357" lower_limit="305" upper_limit="418"/>
                    <measurement group_id="O2" value="388" lower_limit="325" upper_limit="463"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="247" lower_limit="213" upper_limit="287"/>
                    <measurement group_id="O2" value="265" lower_limit="220" upper_limit="320"/>
                  </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>Dengue Virus Serotype 1</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMT ratio</param_type>
            <param_value>0.977</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.653</ci_lower_limit>
            <ci_upper_limit>1.46</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Dengue Virus Serotype 2</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMT ratio</param_type>
            <param_value>0.911</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.654</ci_lower_limit>
            <ci_upper_limit>1.27</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Dengue Virus Serotype 3</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMT ratio</param_type>
            <param_value>0.921</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.727</ci_lower_limit>
            <ci_upper_limit>1.17</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Dengue Virus Serotype 4</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMT ratio</param_type>
            <param_value>0.931</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.733</ci_lower_limit>
            <ci_upper_limit>1.18</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>GMTs Against Each Cervarix HPV Antigen (HPV-16 and HPV-18) at Day 0 and 28 Days After Each Cervarix Vaccination in the Previously Dengue Seropositive Participants</title>
        <description>The GMTs against each Cervarix HPV antigen (HPV-16 and HPV-18) were assessed using an ELISA method. Dengue seropositive participants at baseline were defined as those participants with titers &gt;=10 (1/dil) for at least one serotype with the parental dengue virus strain.</description>
        <time_frame>Day 0 and 28 days after each Cervarix vaccination</time_frame>
        <population>Analysis was performed on FAS population. Here, &quot;overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure and &quot;number analyzed&quot; signifies participants with available data for specified categories.</population>
        <group_list>
          <group group_id="O1">
            <title>CYD Dengue Vaccine + Cervarix (Concomitant Administration)</title>
            <description>Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Day 0, Month 6, and Month 12 and 2 doses of Cervarix vaccine 0.5 mL IM concomitantly with the 2 first doses of CYD dengue vaccine.</description>
          </group>
          <group group_id="O2">
            <title>CYD Dengue Vaccine + Cervarix (Sequential Administration)</title>
            <description>Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Month 1, Month 7, and Month 13 along with the 2 doses of Cervarix vaccine 0.5 mL IM at Day 0 and Month 6 sequentially (i.e., one month before) to each of the 2 first doses of CYD dengue vaccine.</description>
          </group>
        </group_list>
        <measure>
          <title>GMTs Against Each Cervarix HPV Antigen (HPV-16 and HPV-18) at Day 0 and 28 Days After Each Cervarix Vaccination in the Previously Dengue Seropositive Participants</title>
          <description>The GMTs against each Cervarix HPV antigen (HPV-16 and HPV-18) were assessed using an ELISA method. Dengue seropositive participants at baseline were defined as those participants with titers &gt;=10 (1/dil) for at least one serotype with the parental dengue virus strain.</description>
          <population>Analysis was performed on FAS population. Here, &quot;overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure and &quot;number analyzed&quot; signifies participants with available data for specified categories.</population>
          <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="154"/>
                <count group_id="O2" value="151"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>HPV-16: Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="154"/>
                    <count group_id="O2" value="151"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.61" lower_limit="1.31" upper_limit="1.97"/>
                    <measurement group_id="O2" value="1.58" lower_limit="1.29" upper_limit="1.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HPV-16: 28 days post vaccination 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="150"/>
                    <count group_id="O2" value="151"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="118" lower_limit="98.7" upper_limit="142"/>
                    <measurement group_id="O2" value="140" lower_limit="116" upper_limit="170"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HPV-16: 28 days post vaccination 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2089" lower_limit="1852" upper_limit="2356"/>
                    <measurement group_id="O2" value="2162" lower_limit="1869" upper_limit="2501"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HPV-18: Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="154"/>
                    <count group_id="O2" value="151"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.34" lower_limit="1.15" upper_limit="1.55"/>
                    <measurement group_id="O2" value="1.34" lower_limit="1.16" upper_limit="1.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HPV-18: 28 days post vaccination 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="150"/>
                    <count group_id="O2" value="151"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.8" lower_limit="44.1" upper_limit="65.7"/>
                    <measurement group_id="O2" value="68.6" lower_limit="56.5" upper_limit="83.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HPV-18: 28 days post vaccination 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="846" lower_limit="752" upper_limit="951"/>
                    <measurement group_id="O2" value="846" lower_limit="728" upper_limit="984"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Seroconversion Against Each Cervarix HPV Antigen (HPV-16 and HPV-18) 28 Days After Each Dose of Cervarix Vaccination in the Previously Dengue Seropositive Participants</title>
        <description>Neutralizing antibodies against each Cervarix HPV antigen (HPV-16 and HPV-18) were assessed using an ELISA method. Seroconversion was defined as changing serostatus from seronegative at baseline to seropositive (greater than [&gt;] lower limit of quantitation [LLOQ] of the assay) or &gt;=4-fold rise in antibody titer if seropositive at baseline (i.e., at least one antibody levels against Cervarix HPV antigens &gt; LLOQ at baseline). The LLOQ for HPV-16 and HPV-18 was less than (&lt;) 2.0 International Units per milliliter (IU/mL).</description>
        <time_frame>28 days after each Cervarix vaccination</time_frame>
        <population>Analysis was performed on FAS population. Here, &quot;overall number of participants&quot; signifies participants evaluable for this outcome measure and &quot;number analyzed&quot; signifies participants with available data for specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>CYD Dengue Vaccine + Cervarix (Concomitant Administration)</title>
            <description>Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Day 0, Month 6, and Month 12 and 2 doses of Cervarix vaccine 0.5 mL IM concomitantly with the 2 first doses of CYD dengue vaccine.</description>
          </group>
          <group group_id="O2">
            <title>CYD Dengue Vaccine + Cervarix (Sequential Administration)</title>
            <description>Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Month 1, Month 7, and Month 13 along with the 2 doses of Cervarix vaccine 0.5 mL IM at Day 0 and Month 6 sequentially (i.e., one month before) to each of the 2 first doses of CYD dengue vaccine.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Seroconversion Against Each Cervarix HPV Antigen (HPV-16 and HPV-18) 28 Days After Each Dose of Cervarix Vaccination in the Previously Dengue Seropositive Participants</title>
          <description>Neutralizing antibodies against each Cervarix HPV antigen (HPV-16 and HPV-18) were assessed using an ELISA method. Seroconversion was defined as changing serostatus from seronegative at baseline to seropositive (greater than [&gt;] lower limit of quantitation [LLOQ] of the assay) or &gt;=4-fold rise in antibody titer if seropositive at baseline (i.e., at least one antibody levels against Cervarix HPV antigens &gt; LLOQ at baseline). The LLOQ for HPV-16 and HPV-18 was less than (&lt;) 2.0 International Units per milliliter (IU/mL).</description>
          <population>Analysis was performed on FAS population. Here, &quot;overall number of participants&quot; signifies participants evaluable for this outcome measure and &quot;number analyzed&quot; signifies 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="154"/>
                <count group_id="O2" value="151"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>HPV-16: 28 days post-vaccination 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="150"/>
                    <count group_id="O2" value="151"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.0" lower_limit="94.3" upper_limit="99.6"/>
                    <measurement group_id="O2" value="99.3" lower_limit="96.4" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HPV-16: 28 days post-vaccination 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.7" lower_limit="95.2" upper_limit="99.8"/>
                    <measurement group_id="O2" value="99.3" lower_limit="96.3" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HPV-18: 28 days post-vaccination 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="150"/>
                    <count group_id="O2" value="151"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="97.6" upper_limit="100.0"/>
                    <measurement group_id="O2" value="98.7" lower_limit="95.3" upper_limit="99.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HPV-18: 28 days post-vaccination 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.3" lower_limit="96.3" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100.0" lower_limit="97.5" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants</title>
        <description>The GMTs against each of the four parental dengue virus serotypes (Serotypes 1, 2, 3, and 4) of CYD dengue vaccine were assessed using the PRNT50 assay. Dengue seropositive participants at baseline were defined as those participants with titers &gt;=10 (1/dil) for at least one serotype with the parental dengue virus strain.</description>
        <time_frame>Day 0 and 28 days after each CYD dengue vaccine vaccination</time_frame>
        <population>Analysis was performed on FAS population. Here, &quot;overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure and &quot;number analyzed&quot; signifies participants with available data for specified categories.</population>
        <group_list>
          <group group_id="O1">
            <title>CYD Dengue Vaccine + Cervarix (Concomitant Administration)</title>
            <description>Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Day 0, Month 6, and Month 12 and 2 doses of Cervarix vaccine 0.5 mL IM concomitantly with the 2 first doses of CYD dengue vaccine.</description>
          </group>
          <group group_id="O2">
            <title>CYD Dengue Vaccine + Cervarix (Sequential Administration)</title>
            <description>Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Month 1, Month 7, and Month 13 along with the 2 doses of Cervarix vaccine 0.5 mL IM at Day 0 and Month 6 sequentially (i.e., one month before) to each of the 2 first doses of CYD dengue vaccine.</description>
          </group>
        </group_list>
        <measure>
          <title>GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants</title>
          <description>The GMTs against each of the four parental dengue virus serotypes (Serotypes 1, 2, 3, and 4) of CYD dengue vaccine were assessed using the PRNT50 assay. Dengue seropositive participants at baseline were defined as those participants with titers &gt;=10 (1/dil) for at least one serotype with the parental dengue virus strain.</description>
          <population>Analysis was performed on FAS population. Here, &quot;overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure and &quot;number analyzed&quot; signifies participants with available data for specified categories.</population>
          <units>titer (1/dilution)</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="154"/>
                <count group_id="O2" value="151"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serotype 1: Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="154"/>
                    <count group_id="O2" value="151"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="150" lower_limit="99.7" upper_limit="225"/>
                    <measurement group_id="O2" value="108" lower_limit="72.1" upper_limit="163"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 1: 28 days post-vaccination 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="150"/>
                    <count group_id="O2" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="711" lower_limit="498" upper_limit="1016"/>
                    <measurement group_id="O2" value="586" lower_limit="409" upper_limit="840"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 1: 28 days post-vaccination 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="146"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="460" lower_limit="336" upper_limit="630"/>
                    <measurement group_id="O2" value="476" lower_limit="337" upper_limit="674"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 1: 28 days post-vaccination 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="143"/>
                    <count group_id="O2" value="140"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="384" lower_limit="291" upper_limit="507"/>
                    <measurement group_id="O2" value="393" lower_limit="292" upper_limit="528"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 2: Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="154"/>
                    <count group_id="O2" value="151"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="193" lower_limit="141" upper_limit="263"/>
                    <measurement group_id="O2" value="188" lower_limit="135" upper_limit="262"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 2: 28 days post-vaccination 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="150"/>
                    <count group_id="O2" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1168" lower_limit="879" upper_limit="1552"/>
                    <measurement group_id="O2" value="1163" lower_limit="847" upper_limit="1597"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 2: 28 days post-vaccination 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="146"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="618" lower_limit="492" upper_limit="776"/>
                    <measurement group_id="O2" value="703" lower_limit="541" upper_limit="913"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 2: 28 days post-vaccination 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="143"/>
                    <count group_id="O2" value="140"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="670" lower_limit="535" upper_limit="839"/>
                    <measurement group_id="O2" value="735" lower_limit="575" upper_limit="940"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 3: Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="154"/>
                    <count group_id="O2" value="151"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.5" lower_limit="72.2" upper_limit="135"/>
                    <measurement group_id="O2" value="90.2" lower_limit="67.2" upper_limit="121"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 3: 28 days post-vaccination 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="150"/>
                    <count group_id="O2" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="499" lower_limit="386" upper_limit="644"/>
                    <measurement group_id="O2" value="503" lower_limit="385" upper_limit="656"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 3: 28 days post-vaccination 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="146"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="299" lower_limit="251" upper_limit="358"/>
                    <measurement group_id="O2" value="361" lower_limit="294" upper_limit="445"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 3: 28 days post-vaccination 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="143"/>
                    <count group_id="O2" value="140"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="357" lower_limit="305" upper_limit="418"/>
                    <measurement group_id="O2" value="388" lower_limit="325" upper_limit="463"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 4: Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="154"/>
                    <count group_id="O2" value="151"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.1" lower_limit="34.6" upper_limit="64.0"/>
                    <measurement group_id="O2" value="38.0" lower_limit="28.4" upper_limit="50.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 4: 28 days post-vaccination 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="150"/>
                    <count group_id="O2" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="423" lower_limit="336" upper_limit="532"/>
                    <measurement group_id="O2" value="449" lower_limit="365" upper_limit="552"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 4: 28 days post-vaccination 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="146"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="267" lower_limit="225" upper_limit="316"/>
                    <measurement group_id="O2" value="262" lower_limit="219" upper_limit="314"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 4: 28 days post-vaccination 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="143"/>
                    <count group_id="O2" value="140"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="247" lower_limit="213" upper_limit="287"/>
                    <measurement group_id="O2" value="265" lower_limit="220" upper_limit="320"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Neutralizing Antibody Titers &gt;=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants</title>
        <description>Dengue neutralizing antibody levels against each of the 4 dengue virus serotypes (Serotypes 1, 2, 3, and 4) were measured by PRNT50. Dengue seropositive participants at baseline were defined as those participants with titers &gt;=10 (1/dil) for at least one serotype with the parental dengue virus strain.</description>
        <time_frame>Day 0 and 28 days after each CYD dengue vaccine vaccination</time_frame>
        <population>Analysis was performed on FAS population. Here, &quot;overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure and &quot;number analyzed&quot; signifies participants with available data for specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>CYD Dengue Vaccine + Cervarix (Concomitant Administration)</title>
            <description>Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Day 0, Month 6, and Month 12 and 2 doses of Cervarix vaccine 0.5 mL IM concomitantly with the 2 first doses of CYD dengue vaccine.</description>
          </group>
          <group group_id="O2">
            <title>CYD Dengue Vaccine + Cervarix (Sequential Administration)</title>
            <description>Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Month 1, Month 7, and Month 13 along with the 2 doses of Cervarix vaccine 0.5 mL IM at Day 0 and Month 6 sequentially (i.e., one month before) to each of the 2 first doses of CYD dengue vaccine.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Neutralizing Antibody Titers &gt;=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants</title>
          <description>Dengue neutralizing antibody levels against each of the 4 dengue virus serotypes (Serotypes 1, 2, 3, and 4) were measured by PRNT50. Dengue seropositive participants at baseline were defined as those participants with titers &gt;=10 (1/dil) for at least one serotype with the parental dengue virus strain.</description>
          <population>Analysis was performed on FAS population. Here, &quot;overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure and &quot;number analyzed&quot; signifies 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="154"/>
                <count group_id="O2" value="151"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serotype 1: Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="154"/>
                    <count group_id="O2" value="151"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.0" lower_limit="66.4" upper_limit="80.8"/>
                    <measurement group_id="O2" value="68.9" lower_limit="60.8" upper_limit="76.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 1: 28 days post-vaccination 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="150"/>
                    <count group_id="O2" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.7" lower_limit="89.8" upper_limit="97.7"/>
                    <measurement group_id="O2" value="95.3" lower_limit="90.5" upper_limit="98.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 1: 28 days post-vaccination 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="146"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.3" lower_limit="93.3" upper_limit="99.3"/>
                    <measurement group_id="O2" value="97.3" lower_limit="93.1" upper_limit="99.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 1: 28 days post-vaccination 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="143"/>
                    <count group_id="O2" value="140"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.3" lower_limit="96.2" upper_limit="100.0"/>
                    <measurement group_id="O2" value="97.9" lower_limit="93.9" upper_limit="99.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 2: Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="154"/>
                    <count group_id="O2" value="151"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.9" lower_limit="87.6" upper_limit="96.4"/>
                    <measurement group_id="O2" value="91.4" lower_limit="85.7" upper_limit="95.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 2: 28 days post-vaccination 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="150"/>
                    <count group_id="O2" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.7" lower_limit="92.4" upper_limit="98.9"/>
                    <measurement group_id="O2" value="93.9" lower_limit="88.8" upper_limit="97.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 2: 28 days post-vaccination 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="146"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="97.6" upper_limit="100.0"/>
                    <measurement group_id="O2" value="98.6" lower_limit="95.1" upper_limit="99.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 2: 28 days post-vaccination 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="143"/>
                    <count group_id="O2" value="140"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="97.5" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100.0" lower_limit="97.4" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 3: Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="154"/>
                    <count group_id="O2" value="151"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.5" lower_limit="75.5" upper_limit="88.1"/>
                    <measurement group_id="O2" value="83.4" lower_limit="76.5" upper_limit="89.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 3: 28 days post-vaccination 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="150"/>
                    <count group_id="O2" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.7" lower_limit="92.4" upper_limit="98.9"/>
                    <measurement group_id="O2" value="96.6" lower_limit="92.3" upper_limit="98.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 3: 28 days post-vaccination 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="146"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.3" lower_limit="96.3" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100.0" lower_limit="97.5" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 3: 28 days post-vaccination 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="143"/>
                    <count group_id="O2" value="140"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.3" lower_limit="96.2" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100.0" lower_limit="97.4" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 4: Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="154"/>
                    <count group_id="O2" value="151"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.8" lower_limit="60.9" upper_limit="76.0"/>
                    <measurement group_id="O2" value="66.9" lower_limit="58.8" upper_limit="74.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 4: 28 days post-vaccination 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="150"/>
                    <count group_id="O2" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.3" lower_limit="93.3" upper_limit="99.3"/>
                    <measurement group_id="O2" value="98.6" lower_limit="95.2" upper_limit="99.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 4: 28 days post-vaccination 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="146"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="97.6" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100.0" lower_limit="97.5" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 4: 28 days post-vaccination 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="143"/>
                    <count group_id="O2" value="140"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="97.5" upper_limit="100.0"/>
                    <measurement group_id="O2" value="98.6" lower_limit="94.9" upper_limit="99.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Neutralizing Antibody Titers &gt;=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants</title>
        <description>Dengue neutralizing antibody levels against each of the 4 dengue virus serotypes (Serotypes 1, 2, 3, and 4) were measured by PRNT50. Dengue seropositive participants at baseline were defined as those participants with titers &gt;=10 (1/dil) for at least one serotype with the parental dengue virus strain.</description>
        <time_frame>Day 0 and 28 days after each CYD dengue vaccination</time_frame>
        <population>Analysis was performed on FAS population. Here, &quot;overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure and &quot;number analyzed&quot; signifies participants with available data for specified categories.</population>
        <group_list>
          <group group_id="O1">
            <title>CYD Dengue Vaccine + Cervarix (Concomitant Administration)</title>
            <description>Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Day 0, Month 6, and Month 12 and 2 doses of Cervarix vaccine 0.5 mL IM concomitantly with the 2 first doses of CYD dengue vaccine.</description>
          </group>
          <group group_id="O2">
            <title>CYD Dengue Vaccine + Cervarix (Sequential Administration)</title>
            <description>Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Month 1, Month 7, and Month 13 along with the 2 doses of Cervarix vaccine 0.5 mL IM at Day 0 and Month 6 sequentially (i.e., one month before) to each of the 2 first doses of CYD dengue vaccine.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Neutralizing Antibody Titers &gt;=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants</title>
          <description>Dengue neutralizing antibody levels against each of the 4 dengue virus serotypes (Serotypes 1, 2, 3, and 4) were measured by PRNT50. Dengue seropositive participants at baseline were defined as those participants with titers &gt;=10 (1/dil) for at least one serotype with the parental dengue virus strain.</description>
          <population>Analysis was performed on FAS population. Here, &quot;overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure and &quot;number analyzed&quot; signifies participants with available data for specified categories.</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="154"/>
                <count group_id="O2" value="151"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At least 1 Serotype: Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="154"/>
                    <count group_id="O2" value="151"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="97.6" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100.0" lower_limit="97.6" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least 1 Serotype: 28 days post-vaccination 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="150"/>
                    <count group_id="O2" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.3" lower_limit="96.3" upper_limit="100.0"/>
                    <measurement group_id="O2" value="99.3" lower_limit="96.3" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least 1 Serotype: 28 days post-vaccination 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="146"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="97.6" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100.0" lower_limit="97.5" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least 1 Serotype: 28 days post-vaccination 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="143"/>
                    <count group_id="O2" value="140"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="97.5" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100.0" lower_limit="97.4" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least 2 Serotype: Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="154"/>
                    <count group_id="O2" value="151"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.4" lower_limit="77.7" upper_limit="89.8"/>
                    <measurement group_id="O2" value="82.8" lower_limit="75.8" upper_limit="88.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least 2 Serotype: 28 days post-vaccination 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="150"/>
                    <count group_id="O2" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.0" lower_limit="94.3" upper_limit="99.6"/>
                    <measurement group_id="O2" value="98.0" lower_limit="94.2" upper_limit="99.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least 2 Serotype: 28 days post-vaccination 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="146"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="97.6" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100.0" lower_limit="97.5" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least 2 Serotype: 28 days post-vaccination 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="143"/>
                    <count group_id="O2" value="140"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="97.5" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100.0" lower_limit="97.4" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least 3 Serotype: Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="154"/>
                    <count group_id="O2" value="151"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.0" lower_limit="66.4" upper_limit="80.8"/>
                    <measurement group_id="O2" value="72.8" lower_limit="65.0" upper_limit="79.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least 3 Serotype: 28 days post-vaccination 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="150"/>
                    <count group_id="O2" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.3" lower_limit="90.6" upper_limit="98.1"/>
                    <measurement group_id="O2" value="94.6" lower_limit="89.6" upper_limit="97.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least 3 Serotype: 28 days post-vaccination 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="146"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.3" lower_limit="96.3" upper_limit="100.0"/>
                    <measurement group_id="O2" value="98.6" lower_limit="95.1" upper_limit="99.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least 3 Serotype: 28 days post-vaccination 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="143"/>
                    <count group_id="O2" value="140"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="97.5" upper_limit="100.0"/>
                    <measurement group_id="O2" value="98.6" lower_limit="94.9" upper_limit="99.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>All 4 Serotypes: Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="154"/>
                    <count group_id="O2" value="151"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.7" lower_limit="51.5" upper_limit="67.6"/>
                    <measurement group_id="O2" value="55.0" lower_limit="46.7" upper_limit="63.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>All 4 Serotypes: 28 days post-vaccination 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="150"/>
                    <count group_id="O2" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.7" lower_limit="87.3" upper_limit="96.3"/>
                    <measurement group_id="O2" value="92.6" lower_limit="87.1" upper_limit="96.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>All 4 Serotypes: 28 days post-vaccination 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="146"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.3" lower_limit="93.3" upper_limit="99.3"/>
                    <measurement group_id="O2" value="97.3" lower_limit="93.1" upper_limit="99.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>All 4 Serotypes: 28 days post-vaccination 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="143"/>
                    <count group_id="O2" value="140"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.6" lower_limit="95.0" upper_limit="99.8"/>
                    <measurement group_id="O2" value="97.9" lower_limit="93.9" upper_limit="99.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants</title>
        <description>Dengue neutralizing antibody levels against each of the 4 dengue virus serotypes (Serotypes 1, 2, 3, and 4) were measured by PRNT50. Dengue seropositive participants at baseline were defined as those participants with titers &gt;=10 (1/dil) for at least one serotype with the parental dengue virus strain. Percentage of participants with neutralizing antibody titers above pre-defined thresholds (&lt;10, &gt;=10 and &gt;=100 [1/dil]) against each dengue virus serotypes of CYD were reported.</description>
        <time_frame>Day 0 and 28 days after each CYD dengue vaccination</time_frame>
        <population>Analysis was performed on FAS population. Here, &quot;overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure and &quot;number analyzed&quot; signifies participants with available data for specified categories.</population>
        <group_list>
          <group group_id="O1">
            <title>CYD Dengue Vaccine + Cervarix (Concomitant Administration)</title>
            <description>Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Day 0, Month 6, and Month 12 and 2 doses of Cervarix vaccine 0.5 mL IM concomitantly with the 2 first doses of CYD dengue vaccine.</description>
          </group>
          <group group_id="O2">
            <title>CYD Dengue Vaccine + Cervarix (Sequential Administration)</title>
            <description>Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Month 1, Month 7, and Month 13 along with the 2 doses of Cervarix vaccine 0.5 mL IM at Day 0 and Month 6 sequentially (i.e., one month before) to each of the 2 first doses of CYD dengue vaccine.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants</title>
          <description>Dengue neutralizing antibody levels against each of the 4 dengue virus serotypes (Serotypes 1, 2, 3, and 4) were measured by PRNT50. Dengue seropositive participants at baseline were defined as those participants with titers &gt;=10 (1/dil) for at least one serotype with the parental dengue virus strain. Percentage of participants with neutralizing antibody titers above pre-defined thresholds (&lt;10, &gt;=10 and &gt;=100 [1/dil]) against each dengue virus serotypes of CYD were reported.</description>
          <population>Analysis was performed on FAS population. Here, &quot;overall number of participants analyzed&quot; signifies participants evaluable for this outcome measure and &quot;number analyzed&quot; signifies participants with available data for specified categories.</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="154"/>
                <count group_id="O2" value="151"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serotype 1: Pre-vaccination 1 &lt;10 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="154"/>
                    <count group_id="O2" value="151"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.0" lower_limit="19.2" upper_limit="33.6"/>
                    <measurement group_id="O2" value="31.1" lower_limit="23.8" upper_limit="39.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 1: Pre-vaccination 1 &gt;=10 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="154"/>
                    <count group_id="O2" value="151"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.0" lower_limit="66.4" upper_limit="80.8"/>
                    <measurement group_id="O2" value="68.9" lower_limit="60.8" upper_limit="76.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 1: Pre-vaccination 1 &gt;=100 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="154"/>
                    <count group_id="O2" value="151"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.0" lower_limit="52.9" upper_limit="68.8"/>
                    <measurement group_id="O2" value="56.3" lower_limit="48.0" upper_limit="64.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 1: Post-vaccination 1 &lt;10 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="150"/>
                    <count group_id="O2" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.3" lower_limit="2.3" upper_limit="10.2"/>
                    <measurement group_id="O2" value="4.7" lower_limit="1.9" upper_limit="9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 1: Post-vaccination 1 &gt;=10 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="150"/>
                    <count group_id="O2" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.7" lower_limit="89.8" upper_limit="97.7"/>
                    <measurement group_id="O2" value="95.3" lower_limit="90.5" upper_limit="98.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 1: Post-vaccination 1 &gt;=100 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="150"/>
                    <count group_id="O2" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.0" lower_limit="74.9" upper_limit="87.8"/>
                    <measurement group_id="O2" value="78.4" lower_limit="70.9" upper_limit="84.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 1: Post-vaccination 2 &lt;10 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="146"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" lower_limit="0.7" upper_limit="6.7"/>
                    <measurement group_id="O2" value="2.7" lower_limit="0.8" upper_limit="6.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 1: Post-vaccination 2 &gt;=10 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="146"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.3" lower_limit="93.3" upper_limit="99.3"/>
                    <measurement group_id="O2" value="97.3" lower_limit="93.1" upper_limit="99.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 1: Post-vaccination 2 &gt;=100 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="146"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.2" lower_limit="69.6" upper_limit="83.7"/>
                    <measurement group_id="O2" value="72.6" lower_limit="64.6" upper_limit="79.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 1: Post-vaccination 3 &lt;10 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="143"/>
                    <count group_id="O2" value="140"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" lower_limit="0.0" upper_limit="3.8"/>
                    <measurement group_id="O2" value="2.1" lower_limit="0.4" upper_limit="6.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 1: Post-vaccination 3 &gt;=10 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="143"/>
                    <count group_id="O2" value="140"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.3" lower_limit="96.2" upper_limit="100.0"/>
                    <measurement group_id="O2" value="97.9" lower_limit="93.9" upper_limit="99.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 1: Post-vaccination 3 &gt;=100 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="143"/>
                    <count group_id="O2" value="140"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.8" lower_limit="66.9" upper_limit="81.7"/>
                    <measurement group_id="O2" value="76.4" lower_limit="68.5" upper_limit="83.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 2: Pre-vaccination 1 &lt;10 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="154"/>
                    <count group_id="O2" value="151"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.1" lower_limit="3.6" upper_limit="12.4"/>
                    <measurement group_id="O2" value="8.6" lower_limit="4.7" upper_limit="14.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 2: Pre-vaccination 1 &gt;=10 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="154"/>
                    <count group_id="O2" value="151"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.9" lower_limit="87.6" upper_limit="96.4"/>
                    <measurement group_id="O2" value="91.4" lower_limit="85.7" upper_limit="95.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 2: Pre-vaccination 1 &gt;=100 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="154"/>
                    <count group_id="O2" value="151"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.1" lower_limit="50.9" upper_limit="66.9"/>
                    <measurement group_id="O2" value="61.6" lower_limit="53.3" upper_limit="69.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 2: Post-vaccination 1 &lt;10 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="150"/>
                    <count group_id="O2" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3" lower_limit="1.1" upper_limit="7.6"/>
                    <measurement group_id="O2" value="6.1" lower_limit="2.8" upper_limit="11.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 2: Post-vaccination 1 &gt;=10 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="150"/>
                    <count group_id="O2" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.7" lower_limit="92.4" upper_limit="98.9"/>
                    <measurement group_id="O2" value="93.9" lower_limit="88.8" upper_limit="97.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 2: Post-vaccination 1 &gt;=100 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="150"/>
                    <count group_id="O2" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.3" lower_limit="85.6" upper_limit="95.3"/>
                    <measurement group_id="O2" value="91.9" lower_limit="86.3" upper_limit="95.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 2: Post-vaccination 2 &lt;10 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="146"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="2.4"/>
                    <measurement group_id="O2" value="1.4" lower_limit="0.2" upper_limit="4.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 2: Post-vaccination 2 &gt;=10 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="146"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="97.6" upper_limit="100.0"/>
                    <measurement group_id="O2" value="98.6" lower_limit="95.1" upper_limit="99.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 2: Post-vaccination 2 &gt;=100 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="146"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.6" lower_limit="84.7" upper_limit="94.8"/>
                    <measurement group_id="O2" value="90.4" lower_limit="84.4" upper_limit="94.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 2: Post-vaccination 3 &lt;10 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="143"/>
                    <count group_id="O2" value="140"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="2.5"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 2: Post-vaccination 3 &gt;=10 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="143"/>
                    <count group_id="O2" value="140"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="97.5" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100.0" lower_limit="97.4" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 2: Post-vaccination 3 &gt;=100 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="143"/>
                    <count group_id="O2" value="140"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.1" lower_limit="90.2" upper_limit="98.0"/>
                    <measurement group_id="O2" value="90.7" lower_limit="84.6" upper_limit="95.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 3: Pre-vaccination 1 &lt;10 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="154"/>
                    <count group_id="O2" value="151"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.5" lower_limit="11.9" upper_limit="24.5"/>
                    <measurement group_id="O2" value="16.6" lower_limit="11.0" upper_limit="23.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 3: Pre-vaccination 1 &gt;=10 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="154"/>
                    <count group_id="O2" value="151"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.5" lower_limit="75.5" upper_limit="88.1"/>
                    <measurement group_id="O2" value="83.4" lower_limit="76.5" upper_limit="89.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 3: Pre-vaccination 1 &gt;=100 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="154"/>
                    <count group_id="O2" value="151"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.3" lower_limit="43.1" upper_limit="59.4"/>
                    <measurement group_id="O2" value="49.0" lower_limit="40.8" upper_limit="57.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 3: Post-vaccination 1 &lt;10 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="150"/>
                    <count group_id="O2" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3" lower_limit="1.1" upper_limit="7.6"/>
                    <measurement group_id="O2" value="3.4" lower_limit="1.1" upper_limit="7.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 3: Post-vaccination 1 &gt;=10 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="150"/>
                    <count group_id="O2" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.7" lower_limit="92.4" upper_limit="98.9"/>
                    <measurement group_id="O2" value="96.6" lower_limit="92.3" upper_limit="98.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 3: Post-vaccination 1 &gt;=100 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="150"/>
                    <count group_id="O2" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.7" lower_limit="82.5" upper_limit="93.3"/>
                    <measurement group_id="O2" value="87.8" lower_limit="81.5" upper_limit="92.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 3: Post-vaccination 2 &lt;10 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="146"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" lower_limit="0.0" upper_limit="3.7"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 3: Post-vaccination 2 &gt;=10 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="146"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.3" lower_limit="96.3" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100.0" lower_limit="97.5" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 3: Post-vaccination 2 &gt;=100 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="146"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.2" lower_limit="80.8" upper_limit="92.1"/>
                    <measurement group_id="O2" value="87.0" lower_limit="80.4" upper_limit="92.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 3: Post-vaccination 3 &lt;10 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="143"/>
                    <count group_id="O2" value="140"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" lower_limit="0.0" upper_limit="3.8"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 3: Post-vaccination 3 &gt;=10 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="143"/>
                    <count group_id="O2" value="140"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.3" lower_limit="96.2" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100.0" lower_limit="97.4" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 3: Post-vaccination 3 &gt;=100 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="143"/>
                    <count group_id="O2" value="140"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.4" lower_limit="89.3" upper_limit="97.6"/>
                    <measurement group_id="O2" value="90.7" lower_limit="84.6" upper_limit="95.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 4: Pre-vaccination 1 &lt;10 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="154"/>
                    <count group_id="O2" value="151"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.2" lower_limit="24.0" upper_limit="39.1"/>
                    <measurement group_id="O2" value="33.1" lower_limit="25.7" upper_limit="41.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 4: Pre-vaccination 1 &gt;=10 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="154"/>
                    <count group_id="O2" value="151"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.8" lower_limit="60.9" upper_limit="76.0"/>
                    <measurement group_id="O2" value="66.9" lower_limit="58.8" upper_limit="74.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 4: Pre-vaccination 1 &gt;=100 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="154"/>
                    <count group_id="O2" value="151"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.1" lower_limit="25.8" upper_limit="41.1"/>
                    <measurement group_id="O2" value="29.8" lower_limit="22.6" upper_limit="37.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 4: Post-vaccination 1 &lt;10 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="150"/>
                    <count group_id="O2" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" lower_limit="0.7" upper_limit="6.7"/>
                    <measurement group_id="O2" value="1.4" lower_limit="0.2" upper_limit="4.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 4: Post-vaccination 1 &gt;=10 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="150"/>
                    <count group_id="O2" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.3" lower_limit="93.3" upper_limit="99.3"/>
                    <measurement group_id="O2" value="98.6" lower_limit="95.2" upper_limit="99.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 4: Post-vaccination 1 &gt;=100 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="150"/>
                    <count group_id="O2" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.3" lower_limit="80.9" upper_limit="92.2"/>
                    <measurement group_id="O2" value="89.9" lower_limit="83.8" upper_limit="94.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 4: Post-vaccination 2 &lt;10 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="146"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="2.4"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 4: Post-vaccination 2 &gt;=10 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="146"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="97.6" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100.0" lower_limit="97.5" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 4: Post-vaccination 2 &gt;=100 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="146"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.6" lower_limit="75.5" upper_limit="88.3"/>
                    <measurement group_id="O2" value="80.1" lower_limit="72.7" upper_limit="86.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 4: Post-vaccination 3 &lt;10 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="143"/>
                    <count group_id="O2" value="140"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="2.5"/>
                    <measurement group_id="O2" value="1.4" lower_limit="0.2" upper_limit="5.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 4: Post-vaccination 3 &gt;=10 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="143"/>
                    <count group_id="O2" value="140"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="97.5" upper_limit="100.0"/>
                    <measurement group_id="O2" value="98.6" lower_limit="94.9" upper_limit="99.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 4: Post-vaccination 3 &gt;=100 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="143"/>
                    <count group_id="O2" value="140"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.2" lower_limit="76.1" upper_limit="88.9"/>
                    <measurement group_id="O2" value="83.6" lower_limit="76.4" upper_limit="89.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Reporting Immediate Adverse Events (AEs) Following Vaccination With Cervarix or CYD Dengue Vaccine</title>
        <description>Any unsolicited systemic AE occurred during the first 30 minutes post-vaccination was recorded on the case report form (CRF) as immediate AE.</description>
        <time_frame>Within 30 minutes after each and any vaccination</time_frame>
        <population>Analysis was performed on safety analysis set which included those participants who had received at least one dose of the study vaccines. Here, &quot;number analyzed&quot; signifies participants with available data for specified categories.</population>
        <group_list>
          <group group_id="O1">
            <title>CYD Dengue Vaccine + Cervarix (Concomitant Administration)</title>
            <description>Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Day 0, Month 6, and Month 12 and 2 doses of Cervarix vaccine 0.5 mL IM concomitantly with the 2 first doses of CYD dengue vaccine.</description>
          </group>
          <group group_id="O2">
            <title>CYD Dengue Vaccine + Cervarix (Sequential Administration)</title>
            <description>Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Month 1, Month 7, and Month 13 along with the 2 doses of Cervarix vaccine 0.5 mL IM at Day 0 and Month 6 sequentially (i.e., one month before) to each of the 2 first doses of CYD dengue vaccine.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting Immediate Adverse Events (AEs) Following Vaccination With Cervarix or CYD Dengue Vaccine</title>
          <description>Any unsolicited systemic AE occurred during the first 30 minutes post-vaccination was recorded on the case report form (CRF) as immediate AE.</description>
          <population>Analysis was performed on safety analysis set which included those participants who had received at least one dose of the study vaccines. Here, &quot;number analyzed&quot; signifies participants with available data for specified categories.</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="237"/>
                <count group_id="O2" value="241"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>After any CYD/Cervarix vaccination</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="237"/>
                    <count group_id="O2" value="241"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post CYD/Cervarix vaccination 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="237"/>
                    <count group_id="O2" value="241"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post CYD/Cervarix vaccination 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="227"/>
                    <count group_id="O2" value="229"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post CYD vaccination 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="145"/>
                    <count group_id="O2" value="141"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine</title>
        <description>Solicited injection site reactions included pain, erythema, and swelling.</description>
        <time_frame>Up to 7 days after each and any vaccination</time_frame>
        <population>Analysis was performed on safety analysis set. Here, &quot;number analyzed&quot; signifies participants with available data for specified categories.</population>
        <group_list>
          <group group_id="O1">
            <title>CYD Dengue Vaccine + Cervarix (Concomitant Administration)</title>
            <description>Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Day 0, Month 6, and Month 12 and 2 doses of Cervarix vaccine 0.5 mL IM concomitantly with the 2 first doses of CYD dengue vaccine.</description>
          </group>
          <group group_id="O2">
            <title>CYD Dengue Vaccine + Cervarix (Sequential Administration)</title>
            <description>Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Month 1, Month 7, and Month 13 along with the 2 doses of Cervarix vaccine 0.5 mL IM at Day 0 and Month 6 sequentially (i.e., one month before) to each of the 2 first doses of CYD dengue vaccine.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine</title>
          <description>Solicited injection site reactions included pain, erythema, and swelling.</description>
          <population>Analysis was performed on safety analysis set. Here, &quot;number analyzed&quot; signifies participants with available data for specified categories.</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="237"/>
                <count group_id="O2" value="241"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pain: Post any CYD/Cervarix vaccine</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="231"/>
                    <count group_id="O2" value="234"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="212"/>
                    <measurement group_id="O2" value="221"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain: Post CYD/Cervarix vaccination 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="231"/>
                    <count group_id="O2" value="234"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="202"/>
                    <measurement group_id="O2" value="206"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain: Post CYD/Cervarix vaccination 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="226"/>
                    <count group_id="O2" value="229"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="173"/>
                    <measurement group_id="O2" value="169"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain: Post CYD vaccination 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="144"/>
                    <count group_id="O2" value="140"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65"/>
                    <measurement group_id="O2" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema: Post any CYD/Cervarix vaccine</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="231"/>
                    <count group_id="O2" value="234"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64"/>
                    <measurement group_id="O2" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema: Post CYD/Cervarix vaccination 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="231"/>
                    <count group_id="O2" value="234"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49"/>
                    <measurement group_id="O2" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema: Post CYD/Cervarix vaccination 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="226"/>
                    <count group_id="O2" value="229"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                    <measurement group_id="O2" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema: Post CYD vaccination 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="144"/>
                    <count group_id="O2" value="140"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling: Post any CYD/Cervarix vaccine</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="231"/>
                    <count group_id="O2" value="234"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73"/>
                    <measurement group_id="O2" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling: Post CYD/Cervarix vaccination 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="231"/>
                    <count group_id="O2" value="234"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55"/>
                    <measurement group_id="O2" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling: Post CYD/Cervarix vaccination 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="226"/>
                    <count group_id="O2" value="229"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                    <measurement group_id="O2" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling: Post CYD vaccination 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="144"/>
                    <count group_id="O2" value="139"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine</title>
        <description>Solicited systemic reactions included Fever, Headache, Malaise, Myalgia, and Asthenia. At Visit 1 and Visit 4, participants from Group 1 received both Cervarix and CYD vaccination and participants from Group 2 received only Cervarix vaccination. At Visit 2 and Visit 5, only participants from Group 2 received CYD vaccination whereas the participants from Group 1 received no vaccination.</description>
        <time_frame>Up to 14 days after any and each vaccination</time_frame>
        <population>Analysis was performed on safety analysis set. Here, &quot;number analyzed&quot; signifies participants with available data for specified categories.</population>
        <group_list>
          <group group_id="O1">
            <title>CYD Dengue Vaccine + Cervarix (Concomitant Administration)</title>
            <description>Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Day 0, Month 6, and Month 12 and 2 doses of Cervarix vaccine 0.5 mL IM concomitantly with the 2 first doses of CYD dengue vaccine.</description>
          </group>
          <group group_id="O2">
            <title>CYD Dengue Vaccine + Cervarix (Sequential Administration)</title>
            <description>Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Month 1, Month 7, and Month 13 along with the 2 doses of Cervarix vaccine 0.5 mL IM at Day 0 and Month 6 sequentially (i.e., one month before) to each of the 2 first doses of CYD dengue vaccine.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine</title>
          <description>Solicited systemic reactions included Fever, Headache, Malaise, Myalgia, and Asthenia. At Visit 1 and Visit 4, participants from Group 1 received both Cervarix and CYD vaccination and participants from Group 2 received only Cervarix vaccination. At Visit 2 and Visit 5, only participants from Group 2 received CYD vaccination whereas the participants from Group 1 received no vaccination.</description>
          <population>Analysis was performed on safety analysis set. Here, &quot;number analyzed&quot; signifies participants with available data for specified categories.</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="237"/>
                <count group_id="O2" value="241"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Fever: Post any vaccination</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="230"/>
                    <count group_id="O2" value="234"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever: Post vaccination 1 (Visit 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="230"/>
                    <count group_id="O2" value="234"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever: Post CYD vaccination 1 (Visit 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="230"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever: Post vaccination 2 (Visit 4)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="216"/>
                    <count group_id="O2" value="228"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever: Post CYD vaccination 2 (Visit 5)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="227"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever: Post CYD vaccination 3 (Visit 7)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="143"/>
                    <count group_id="O2" value="139"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache: Post any vaccination</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="231"/>
                    <count group_id="O2" value="234"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="101"/>
                    <measurement group_id="O2" value="111"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache: Post vaccination 1 (Visit 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="231"/>
                    <count group_id="O2" value="234"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83"/>
                    <measurement group_id="O2" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache: Post CYD vaccination 1 (Visit 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="231"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache: Post vaccination 2 (Visit 4)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="226"/>
                    <count group_id="O2" value="229"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47"/>
                    <measurement group_id="O2" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache: Post CYD vaccination 2 (Visit 5)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="227"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache: Post CYD vaccination 3 (Visit 7)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="144"/>
                    <count group_id="O2" value="140"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Malaise: Post any vaccination</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="231"/>
                    <count group_id="O2" value="234"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="113"/>
                    <measurement group_id="O2" value="133"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Malaise: Post vaccination 1 (Visit 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="231"/>
                    <count group_id="O2" value="234"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84"/>
                    <measurement group_id="O2" value="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Malaise: Post CYD vaccination 1 (Visit 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="231"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Malaise: Post vaccination 2 (Visit 4)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="226"/>
                    <count group_id="O2" value="229"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73"/>
                    <measurement group_id="O2" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Malaise: Post CYD vaccination 2 (Visit 5)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="227"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Malaise: Post CYD vaccination 3 (Visit 7)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="144"/>
                    <count group_id="O2" value="140"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia: Post any vaccination</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="231"/>
                    <count group_id="O2" value="234"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="160"/>
                    <measurement group_id="O2" value="168"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia: Post vaccination 1 (Visit 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="231"/>
                    <count group_id="O2" value="234"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="129"/>
                    <measurement group_id="O2" value="124"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia: Post CYD vaccination 1 (Visit 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="231"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia: Post vaccination 2 (Visit 4)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="226"/>
                    <count group_id="O2" value="229"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96"/>
                    <measurement group_id="O2" value="95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia: Post CYD vaccination 2 (Visit 5)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="227"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia: Post CYD vaccination 3 (Visit 7)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="144"/>
                    <count group_id="O2" value="140"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asthenia: Post any vaccination</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="231"/>
                    <count group_id="O2" value="234"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93"/>
                    <measurement group_id="O2" value="95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asthenia: Post vaccination 1 (Visit 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="231"/>
                    <count group_id="O2" value="234"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72"/>
                    <measurement group_id="O2" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asthenia: Post CYD vaccination 1 (Visit 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="231"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asthenia: Post vaccination 2 (Visit 4)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="226"/>
                    <count group_id="O2" value="229"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51"/>
                    <measurement group_id="O2" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asthenia: Post CYD vaccination 2 (Visit 5)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="227"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asthenia: Post CYD vaccination 3 (Visit 7)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="144"/>
                    <count group_id="O2" value="140"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Reporting Unsolicited AEs Following Vaccination With Cervarix or CYD Dengue Vaccine</title>
        <description>An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the CRF in terms of diagnosis and/or onset post-vaccination. At Visit 1 and Visit 4, participants from Group 1 received both Cervarix and CYD vaccination and participants from Group 2 received only Cervarix vaccination. At Visit 2 and Visit 5, only participants from Group 2 received CYD vaccination whereas the participants from Group 1 received no vaccination.</description>
        <time_frame>Up to 28 days after any and each vaccination</time_frame>
        <population>Analysis was performed on safety analysis set. Here, &quot;number analyzed&quot; signifies participants with available data for specified categories.</population>
        <group_list>
          <group group_id="O1">
            <title>CYD Dengue Vaccine + Cervarix (Concomitant Administration)</title>
            <description>Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Day 0, Month 6, and Month 12 and 2 doses of Cervarix vaccine 0.5 mL IM concomitantly with the 2 first doses of CYD dengue vaccine.</description>
          </group>
          <group group_id="O2">
            <title>CYD Dengue Vaccine + Cervarix (Sequential Administration)</title>
            <description>Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Month 1, Month 7, and Month 13 along with the 2 doses of Cervarix vaccine 0.5 mL IM at Day 0 and Month 6 sequentially (i.e., one month before) to each of the 2 first doses of CYD dengue vaccine.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting Unsolicited AEs Following Vaccination With Cervarix or CYD Dengue Vaccine</title>
          <description>An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the CRF in terms of diagnosis and/or onset post-vaccination. At Visit 1 and Visit 4, participants from Group 1 received both Cervarix and CYD vaccination and participants from Group 2 received only Cervarix vaccination. At Visit 2 and Visit 5, only participants from Group 2 received CYD vaccination whereas the participants from Group 1 received no vaccination.</description>
          <population>Analysis was performed on safety analysis set. Here, &quot;number analyzed&quot; signifies participants with available data for specified categories.</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="237"/>
                <count group_id="O2" value="241"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Post any vaccination</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="237"/>
                    <count group_id="O2" value="241"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50"/>
                    <measurement group_id="O2" value="76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post vaccination 1 (Visit 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="237"/>
                    <count group_id="O2" value="241"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O2" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post CYD vaccination 1 (Visit 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="233"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post vaccination 2 (Visit 4)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="227"/>
                    <count group_id="O2" value="229"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post CYD vaccination 2 (Visit 5)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="228"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post CYD vaccination 3 (Visit 7)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="145"/>
                    <count group_id="O2" value="141"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Reporting Non-serious Adverse Event of Special Interests (AESIs) Following Vaccination With Cervarix or CYD Dengue Vaccine</title>
        <description>AESI were AEs that were considered by the Sponsor to be relevant for the monitoring of the safety profile of the investigational vaccine.</description>
        <time_frame>Up to 7 days after any and each vaccination</time_frame>
        <population>Analysis was performed on safety analysis set. Here, 'number analyzed' signifies participants with available data for specified categories.</population>
        <group_list>
          <group group_id="O1">
            <title>CYD Dengue Vaccine + Cervarix (Concomitant Administration)</title>
            <description>Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Day 0, Month 6, and Month 12 and 2 doses of Cervarix vaccine 0.5 mL IM concomitantly with the 2 first doses of CYD dengue vaccine.</description>
          </group>
          <group group_id="O2">
            <title>CYD Dengue Vaccine + Cervarix (Sequential Administration)</title>
            <description>Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Month 1, Month 7, and Month 13 along with the 2 doses of Cervarix vaccine 0.5 mL IM at Day 0 and Month 6 sequentially (i.e., one month before) to each of the 2 first doses of CYD dengue vaccine.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting Non-serious Adverse Event of Special Interests (AESIs) Following Vaccination With Cervarix or CYD Dengue Vaccine</title>
          <description>AESI were AEs that were considered by the Sponsor to be relevant for the monitoring of the safety profile of the investigational vaccine.</description>
          <population>Analysis was performed on safety analysis set. Here, 'number analyzed' signifies participants with available data for specified categories.</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="237"/>
                <count group_id="O2" value="241"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Post any CYD/Cervarix vaccination</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="237"/>
                    <count group_id="O2" value="241"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post CYD/Cervarix vaccination 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="237"/>
                    <count group_id="O2" value="241"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post CYD/Cervarix vaccination 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="227"/>
                    <count group_id="O2" value="229"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post CYD/Cervarix vaccination 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="145"/>
                    <count group_id="O2" value="141"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Reporting Serious Adverse Events (SAEs) Including Serious AESIs Following Vaccination With Cervarix or CYD Dengue Vaccine</title>
        <description>An SAEs were AEs resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or a medically important event. An AESIs were AEs that were considered by the Sponsor to be relevant for the monitoring of the safety profile of the investigational vaccine.</description>
        <time_frame>From Day 0 up to 6 months after the last CYD or Cervarix vaccination</time_frame>
        <population>Analysis was performed on safety analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>CYD Dengue Vaccine + Cervarix (Concomitant Administration)</title>
            <description>Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Day 0, Month 6, and Month 12 and 2 doses of Cervarix vaccine 0.5 mL IM concomitantly with the 2 first doses of CYD dengue vaccine.</description>
          </group>
          <group group_id="O2">
            <title>CYD Dengue Vaccine + Cervarix (Sequential Administration)</title>
            <description>Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Month 1, Month 7, and Month 13 along with the 2 doses of Cervarix vaccine 0.5 mL IM at Day 0 and Month 6 sequentially (i.e., one month before) to each of the 2 first doses of CYD dengue vaccine.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting Serious Adverse Events (SAEs) Including Serious AESIs Following Vaccination With Cervarix or CYD Dengue Vaccine</title>
          <description>An SAEs were AEs resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or a medically important event. An AESIs were AEs that were considered by the Sponsor to be relevant for the monitoring of the safety profile of the investigational vaccine.</description>
          <population>Analysis was performed on safety analysis set.</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="237"/>
                <count group_id="O2" value="241"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serious AESI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Reporting Cases of Virologically Confirmed Dengue (VCD) Hospitalization Following Vaccination With Cervarix or CYD Dengue Vaccine</title>
        <description>Hospitalized suspected dengue case was defined as an acute febrile illness with diagnosis of dengue requiring hospitalization (with bed attribution). In such cases, 1 unplanned acute blood sample (within the first 5 days after fever onset) was collected for virological confirmation of hospitalized suspected dengue case. A suspected case was considered VCD if there was a detection of wild type dengue virus by dengue non-structural protein 1 antigen ELISA and/or dengue reverse transcriptase-polymerase chain reactions.</description>
        <time_frame>From Day 0 up to 6 months after the last CYD or Cervarix vaccination</time_frame>
        <population>Analysis was performed on safety analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>CYD Dengue Vaccine + Cervarix (Concomitant Administration)</title>
            <description>Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Day 0, Month 6, and Month 12 and 2 doses of Cervarix vaccine 0.5 mL IM concomitantly with the 2 first doses of CYD dengue vaccine.</description>
          </group>
          <group group_id="O2">
            <title>CYD Dengue Vaccine + Cervarix (Sequential Administration)</title>
            <description>Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Month 1, Month 7, and Month 13 along with the 2 doses of Cervarix vaccine 0.5 mL IM at Day 0 and Month 6 sequentially (i.e., one month before) to each of the 2 first doses of CYD dengue vaccine.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting Cases of Virologically Confirmed Dengue (VCD) Hospitalization Following Vaccination With Cervarix or CYD Dengue Vaccine</title>
          <description>Hospitalized suspected dengue case was defined as an acute febrile illness with diagnosis of dengue requiring hospitalization (with bed attribution). In such cases, 1 unplanned acute blood sample (within the first 5 days after fever onset) was collected for virological confirmation of hospitalized suspected dengue case. A suspected case was considered VCD if there was a detection of wild type dengue virus by dengue non-structural protein 1 antigen ELISA and/or dengue reverse transcriptase-polymerase chain reactions.</description>
          <population>Analysis was performed on safety analysis set.</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="237"/>
                <count group_id="O2" value="241"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>AE data were collected from Day 0 up to Day 28 post any vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 14 post vaccination. The SAEs were collected throughout the trial (up to Month 14), i.e,. 6 months after last CYD vaccination.</time_frame>
      <desc>The SR was an AE that was prelisted (i.e., solicited) in the electronic CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set.</desc>
      <group_list>
        <group group_id="E1">
          <title>CYD Dengue Vaccine + Cervarix (Sequential Administration)</title>
          <description>Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Day 0, Month 6, and Month 12 and 2 doses of Cervarix vaccine 0.5 mL IM concomitantly with the 2 first doses of CYD dengue vaccine.</description>
        </group>
        <group group_id="E2">
          <title>CYD Dengue Vaccine + Cervarix (Concomitant Administration)</title>
          <description>Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Month 1, Month 7, and Month 13 along with the 2 doses of Cervarix vaccine 0.5 mL IM at Day 0 and Month 6 sequentially (i.e., one month before) to each of the 2 first doses of CYD dengue vaccine.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 19.0</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="237"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="237"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="237"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Forearm Fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="237"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Gun Shot Wound</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="237"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Radius Fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="237"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Pre-Eclampsia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="237"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="237"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="241"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 19.0</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="222" subjects_at_risk="237"/>
                <counts group_id="E2" subjects_affected="228" subjects_at_risk="241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="139" subjects_affected="93" subjects_at_risk="237"/>
                <counts group_id="E2" events="178" subjects_affected="95" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Injection Site Erythema</sub_title>
                <counts group_id="E1" events="137" subjects_affected="64" subjects_at_risk="237"/>
                <counts group_id="E2" events="116" subjects_affected="61" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Injection Site Pain</sub_title>
                <counts group_id="E1" events="659" subjects_affected="212" subjects_at_risk="237"/>
                <counts group_id="E2" events="628" subjects_affected="221" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Injection Site Swelling</sub_title>
                <counts group_id="E1" events="154" subjects_affected="73" subjects_at_risk="237"/>
                <counts group_id="E2" events="115" subjects_affected="60" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="176" subjects_affected="113" subjects_at_risk="237"/>
                <counts group_id="E2" events="287" subjects_affected="133" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="29" subjects_affected="25" subjects_at_risk="237"/>
                <counts group_id="E2" events="47" subjects_affected="37" subjects_at_risk="241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="237"/>
                <counts group_id="E2" events="26" subjects_affected="22" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="237"/>
                <counts group_id="E2" events="21" subjects_affected="20" subjects_at_risk="241"/>
              </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="251" subjects_affected="160" subjects_at_risk="237"/>
                <counts group_id="E2" events="386" subjects_affected="168" subjects_at_risk="241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="149" subjects_affected="102" subjects_at_risk="237"/>
                <counts group_id="E2" events="227" subjects_affected="113" subjects_at_risk="241"/>
              </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>
    <limitations_and_caveats>Change of population for non-inferiority reduced to dengue seropositive participants and time window for vaccination not reached (study hold), hence non-inferiority analysis not performed &amp; immunogenicity analysis was performed on FAS &amp; not on PPS.</limitations_and_caveats>
    <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/NCT02979535
org study id: CYD71
secondary id: U1111-1161-3455
secondary id: 2019-000994-22
nct id: NCT02979535
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to investigate the immunogenicity and safety of CYD dengue vaccine
      and Cervarix when administered concomitantly or sequentially in healthy female participants
      aged 9-14 years of age.

      Primary objectives:

        -  To demonstrate that the humoral immune response (in terms of geometric mean titers
           [GMTs]) to Cervarix after concomitant administration with the CYD dengue vaccine is
           non-inferior to the humoral immune response (in terms of GMTs) after sequential
           administration with the CYD dengue vaccine measured 28 days after the last dose of
           Cervarix.

        -  To demonstrate that the humoral immune response (in terms of GMTs) to the CYD dengue
           vaccine after concomitant administration with Cervarix is non-inferior to the humoral
           immune response (in terms of GMTs) to the CYD dengue vaccine after sequential
           administration with Cervarix measured 28 days after the last dose of the CYD dengue
           vaccine.

      Secondary Objectives:

        -  To demonstrate that the humoral immune response (in terms of seroconversion) to Cervarix
           after concomitant administration with the CYD dengue vaccine is non-inferior to the
           humoral immune response (in terms of seroconversion) to Cervarix sequential
           administration with the CYD dengue vaccine measured 28 days after the last dose of
           Cervarix.

        -  To describe the humoral immune response to Cervarix at baseline and after each dose of
           Cervarix in each and any group.

        -  To describe the humoral immune response to the CYD dengue vaccine at baseline and after
           each dose of the CYD dengue vaccine, in each and any group.

        -  To describe the safety of Cervarix and CYD dengue vaccine after each and any dose in
           each group.
Participants received 3 doses of the CYD dengue vaccine and 2 doses of Cervarix administered
      either concomitantly or sequentially. Due to a protocol amendment, only previously dengue
      exposed participants (seropositive for dengue before vaccination) were eligible to complete
      the vaccination schedule and be assessed for CYD immunogenicity and human papilloma virus
      (HPV) immunogenicity. Dengue unexposed participants (seronegative for dengue before
      vaccination) did not receive the third CYD dengue vaccine injection, but were followed for
      safety up to 6 months after the last injection.

      Safety assessments included solicited reactions within 7 or 14 days after each injection,
      unsolicited adverse events within 28 days after each injection, and serious adverse events
      during the study period. All participants were included in the assessment of safety up to 6
      months after the last injection.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Geometric Mean Titers (GMTs) Against Each Cervarix Human Papillomavirus (HPV) Antigen (HPV-16 and HPV-18) 28 Days After Last Cervarix Vaccination in the Previously Dengue Seropositive Participants
time frame: 28 days after the last Cervarix vaccination
description: GMTs against each Cervarix HPV antigen (HPV-16 and HPV-18) were assessed using an enzyme-linked immunosorbent assay (ELISA) method. Dengue seropositive participants at baseline were defined as those participants with titers greater than or equal to (>=) 10 (1/dilutions [dil]) for at least one serotype with the parental dengue virus strain.
measure: GMTs Against Each Dengue Virus Serotype 28 Days After the Third CYD Dengue Vaccination in the Previously Dengue Seropositive Participants
time frame: 28 days after third CYD dengue vaccination
description: The GMTs against each of the four parental dengue virus serotypes (Serotypes 1, 2, 3, and 4) of CYD dengue vaccine were assessed using the 50% plaque reduction neutralization test (PRNT50) assay. Dengue seropositive participants at baseline were defined as those participants with titers >=10 (1/dil) for at least one serotype with the parental dengue virus strain.
measure: GMTs Against Each Cervarix HPV Antigen (HPV-16 and HPV-18) at Day 0 and 28 Days After Each Cervarix Vaccination in the Previously Dengue Seropositive Participants
time frame: Day 0 and 28 days after each Cervarix vaccination
description: The GMTs against each Cervarix HPV antigen (HPV-16 and HPV-18) were assessed using an ELISA method. Dengue seropositive participants at baseline were defined as those participants with titers >=10 (1/dil) for at least one serotype with the parental dengue virus strain.
measure: Percentage of Participants With Seroconversion Against Each Cervarix HPV Antigen (HPV-16 and HPV-18) 28 Days After Each Dose of Cervarix Vaccination in the Previously Dengue Seropositive Participants
time frame: 28 days after each Cervarix vaccination
description: Neutralizing antibodies against each Cervarix HPV antigen (HPV-16 and HPV-18) were assessed using an ELISA method. Seroconversion was defined as changing serostatus from seronegative at baseline to seropositive (greater than [>] lower limit of quantitation [LLOQ] of the assay) or >=4-fold rise in antibody titer if seropositive at baseline (i.e., at least one antibody levels against Cervarix HPV antigens > LLOQ at baseline). The LLOQ for HPV-16 and HPV-18 was less than (<) 2.0 International Units per milliliter (IU/mL).
measure: GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants
time frame: Day 0 and 28 days after each CYD dengue vaccine vaccination
description: The GMTs against each of the four parental dengue virus serotypes (Serotypes 1, 2, 3, and 4) of CYD dengue vaccine were assessed using the PRNT50 assay. Dengue seropositive participants at baseline were defined as those participants with titers >=10 (1/dil) for at least one serotype with the parental dengue virus strain.
measure: Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants
time frame: Day 0 and 28 days after each CYD dengue vaccine vaccination
description: Dengue neutralizing antibody levels against each of the 4 dengue virus serotypes (Serotypes 1, 2, 3, and 4) were measured by PRNT50. Dengue seropositive participants at baseline were defined as those participants with titers >=10 (1/dil) for at least one serotype with the parental dengue virus strain.
measure: Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants
time frame: Day 0 and 28 days after each CYD dengue vaccination
description: Dengue neutralizing antibody levels against each of the 4 dengue virus serotypes (Serotypes 1, 2, 3, and 4) were measured by PRNT50. Dengue seropositive participants at baseline were defined as those participants with titers >=10 (1/dil) for at least one serotype with the parental dengue virus strain.
measure: Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants
time frame: Day 0 and 28 days after each CYD dengue vaccination
description: Dengue neutralizing antibody levels against each of the 4 dengue virus serotypes (Serotypes 1, 2, 3, and 4) were measured by PRNT50. Dengue seropositive participants at baseline were defined as those participants with titers >=10 (1/dil) for at least one serotype with the parental dengue virus strain. Percentage of participants with neutralizing antibody titers above pre-defined thresholds (<10, >=10 and >=100 [1/dil]) against each dengue virus serotypes of CYD were reported.
measure: Number of Participants Reporting Immediate Adverse Events (AEs) Following Vaccination With Cervarix or CYD Dengue Vaccine
time frame: Within 30 minutes after each and any vaccination
description: Any unsolicited systemic AE occurred during the first 30 minutes post-vaccination was recorded on the case report form (CRF) as immediate AE.
measure: Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine
time frame: Up to 7 days after each and any vaccination
description: Solicited injection site reactions included pain, erythema, and swelling.
measure: Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine
time frame: Up to 14 days after any and each vaccination
description: Solicited systemic reactions included Fever, Headache, Malaise, Myalgia, and Asthenia. At Visit 1 and Visit 4, participants from Group 1 received both Cervarix and CYD vaccination and participants from Group 2 received only Cervarix vaccination. At Visit 2 and Visit 5, only participants from Group 2 received CYD vaccination whereas the participants from Group 1 received no vaccination.
measure: Number of Participants Reporting Unsolicited AEs Following Vaccination With Cervarix or CYD Dengue Vaccine
time frame: Up to 28 days after any and each vaccination
description: An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the CRF in terms of diagnosis and/or onset post-vaccination. At Visit 1 and Visit 4, participants from Group 1 received both Cervarix and CYD vaccination and participants from Group 2 received only Cervarix vaccination. At Visit 2 and Visit 5, only participants from Group 2 received CYD vaccination whereas the participants from Group 1 received no vaccination.
measure: Number of Participants Reporting Non-serious Adverse Event of Special Interests (AESIs) Following Vaccination With Cervarix or CYD Dengue Vaccine
time frame: Up to 7 days after any and each vaccination
description: AESI were AEs that were considered by the Sponsor to be relevant for the monitoring of the safety profile of the investigational vaccine.
measure: Number of Participants Reporting Serious Adverse Events (SAEs) Including Serious AESIs Following Vaccination With Cervarix or CYD Dengue Vaccine
time frame: From Day 0 up to 6 months after the last CYD or Cervarix vaccination
description: An SAEs were AEs resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or a medically important event. An AESIs were AEs that were considered by the Sponsor to be relevant for the monitoring of the safety profile of the investigational vaccine.
measure: Number of Participants Reporting Cases of Virologically Confirmed Dengue (VCD) Hospitalization Following Vaccination With Cervarix or CYD Dengue Vaccine
time frame: From Day 0 up to 6 months after the last CYD or Cervarix vaccination
description: Hospitalized suspected dengue case was defined as an acute febrile illness with diagnosis of dengue requiring hospitalization (with bed attribution). In such cases, 1 unplanned acute blood sample (within the first 5 days after fever onset) was collected for virological confirmation of hospitalized suspected dengue case. A suspected case was considered VCD if there was a detection of wild type dengue virus by dengue non-structural protein 1 antigen ELISA and/or dengue reverse transcriptase-polymerase chain reactions.
arm group label: CYD Dengue Vaccine + Cervarix (Concomitant Administration)
arm group type: Experimental
description: Participants received 3 doses of CYD dengue vaccine 0.5 milliliter (mL) subcutaneously (SC) at Day 0, Month 6, and Month 12 and 2 doses of Cervarix vaccine 0.5 mL Intramuscularly (IM) concomitantly with the 2 first doses of CYD dengue vaccine.
arm group label: CYD Dengue Vaccine + Cervarix (Sequential Administration)
arm group type: Experimental
description: Participants received 3 doses of CYD dengue vaccine 0.5 mL SC at Month 1, Month 7, and Month 13 along with the 2 doses of Cervarix vaccine 0.5 mL IM at Day 0 and Month 6 sequentially (i.e., one month before) to each of the 2 first doses of CYD dengue vaccine.
intervention type: Biological
intervention name: CYD Dengue Vaccine
description: 0.5 mL, SC at Day 0, Months 6 and 12
arm group label: CYD Dengue Vaccine + Cervarix (Concomitant Administration)
other name: Dengvaxia®
intervention type: Biological
intervention name: CYD Dengue Vaccine
description: 0.5 mL, SC at Months 1, 7, and 13
arm group label: CYD Dengue Vaccine + Cervarix (Sequential Administration)
other name: Dengvaxia®
intervention type: Biological
intervention name: Human Papillomavirus Bivalent [Types 16 and 18] Vaccine, Recombinant
description: 0.5 mL, IM at Day 0 and Month 6
arm group label: CYD Dengue Vaccine + Cervarix (Concomitant Administration)
other name: Cervarix®
intervention type: Biological
intervention name: Human Papillomavirus Bivalent [Types 16 and 18] Vaccine, Recombinant
description: 0.5 mL, IM at Day 0 and Month 6
arm group label: CYD Dengue Vaccine + Cervarix (Sequential Administration)
other name: Cervarix®
criteria: 
gender: Female
minimum age: 9 Years
maximum age: 14 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Medical Director
role: Study Director
affiliation: Sanofi Pasteur SA
facility: 
country: Mexico
responsible party type: Sponsor
mesh term: Dengue
mesh term: Hemorrhagic Fevers, Viral
mesh term: Severe Dengue
mesh term: Fever
mesh term: Hyperthermia
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
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Change of population for non-inferiority reduced to dengue seropositive participants and time window for vaccination not reached (study hold), hence non-inferiority analysis not performed & immunogenicity analysis was performed on FAS & not on PPS.
point of contact: 