<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/NCT02992418</url>
  </required_header>
  <id_info>
    <org_study_id>CYD66</org_study_id>
    <secondary_id>U1111-1161-3294</secondary_id>
    <secondary_id>2019-003136-23</secondary_id>
    <nct_id>NCT02992418</nct_id>
  </id_info>
  <brief_title>Study of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Adacel® in Healthy Subjects</brief_title>
  <official_title>Immunogenicity and Safety of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Adacel® in Healthy Subjects Aged 9 to 60 Years in the Philippines</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>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study was to investigate the immunogenicity and safety of CYD dengue vaccine&#xD;
      and Tetanus Toxoid (T), Reduced Diphtheria Toxoid (D) and Acellular Pertussis Vaccine&#xD;
      Adsorbed (ap) (Tdap) vaccine when both vaccines were administered concomitantly or&#xD;
      sequentially.&#xD;
&#xD;
      Primary Objectives:&#xD;
&#xD;
        -  To demonstrate the non-inferiority of the humoral immune response to the Tdap booster&#xD;
           dose concomitantly administered with the first dose of CYD dengue vaccine as compared to&#xD;
           sequential administration, measured 28 days after Tdap booster dose.&#xD;
&#xD;
        -  To demonstrate the non-inferiority of the humoral immune response to the first dose of&#xD;
           CYD dengue vaccine concomitantly administered with Tdap as compared to sequential&#xD;
           administration, measured 28 days after the first dose of CYD dengue vaccine.&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
        -  To demonstrate the non-inferiority of the humoral immune response of 3 doses of CYD&#xD;
           dengue vaccine with the first dose concomitantly administered with Tdap as compared to&#xD;
           sequential administration, measured 28 days after the third dose of CYD dengue vaccine.&#xD;
&#xD;
        -  To describe the humoral immune response at baseline and 28 days after the first and&#xD;
           third doses of CYD dengue vaccine, in each and any group.&#xD;
&#xD;
        -  To describe the humoral immune response of Tdap vaccine at baseline and 28 days after&#xD;
           concomitant administration with the first dose of CYD dengue vaccine as compared to the&#xD;
           sequential administration, in each and any group.&#xD;
&#xD;
        -  To describe the safety of the CYD dengue vaccine and of the Tdap booster dose after each&#xD;
           and any injection in each group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants were to receive CYD dengue vaccine according to a 3-dose schedule administered 6&#xD;
      months apart, with the first dose of CYD dengue vaccine administered either concomitantly or&#xD;
      sequentially with a booster dose of the Tdap vaccine, Adacel®.&#xD;
&#xD;
      During the conduct of the study, a safety signal was identified which led to the Independent&#xD;
      Data Monitoring Committee (IDMC) recommendation not to vaccinate participants who had never&#xD;
      been infected by dengue prior to the first injection, i.e., dengue non-immune participants.&#xD;
      The protocol was amended accordingly but never implemented due to absence of response of&#xD;
      Health Authorities (HA) from The Philippines.&#xD;
&#xD;
      After having waited for more than 1.5 years, and as the participants became out of window to&#xD;
      complete their immunization schedule and the last safety follow-up call (6 months after the&#xD;
      last dose), the Sponsor decided to stop the trial. Participants only attended a last safety&#xD;
      follow-up visit to terminate the study and were informed about the end of the study. As a&#xD;
      consequence, the study was prematurely terminated before injection of the last dose (3rd&#xD;
      dose) of the CYD dengue vaccine.&#xD;
&#xD;
      As a consequence of the IDMC recommendations, the main immunogenicity analyses were done in&#xD;
      dengue immune participants which is not what was planned in the protocol (and this is why the&#xD;
      primary endpoints are not exactly the same as those defined in the protocol as they were&#xD;
      finally assessed only in dengue immune participants whereas initially it was planned to be&#xD;
      assessed regardless of baseline status).&#xD;
&#xD;
      All participants were assessed for immunogenicity and safety. Safety assessments included&#xD;
      solicited reactions within 7 or 14 days after each injection, unsolicited adverse events&#xD;
      within 28 days after each injection, and serious adverse events during the study period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    No answer received from the Philippines Food and Drug Administration on protocol amendment&#xD;
    issued due to IDMC recommendations. CYD vaccine 3rd dose not given.&#xD;
  </why_stopped>
  <start_date type="Actual">December 19, 2016</start_date>
  <completion_date type="Actual">December 10, 2019</completion_date>
  <primary_completion_date type="Actual">December 10, 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 Concentrations (GMCs) of Antibodies Against Pertussis Antigens (Pertussis Toxoid, Filamentous Hemagglutinin, Pertactin, and Fimbriae 2+3) 28 Days After Dose of Tdap Vaccine in Previously Dengue Immune Participants</measure>
    <time_frame>28 days after Tdap vaccination</time_frame>
    <description>GMCs against each pertussis antigens (pertussis toxoid [PT], filamentous hemagglutinin [FHA], pertactin [PRN], fimbriae types 2 and 3 [FIM2+3]) were assessed using an enzyme-linked immunosorbent assay (ELISA) method and were measured in ELISA unit/milliliter (EU/mL). Dengue immune participants at Baseline were defined as participants with titers &gt;=10 (1/dilution) for at least one serotype with the parental dengue virus strain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens 28 Days After the Dose of Tdap Vaccine in the Previously Dengue Immune Participants</measure>
    <time_frame>28 days after Tdap vaccination</time_frame>
    <description>Seroprotection against diphtheria (Anti-D) and tetanus (Anti-T) antigens was performed by Micrometabolic Inhibition Test - Toxin Neutralization assay (MIT-TNA) and ELISA, respectively. Seroprotection was defined as anti-D and anti-T Ab concentration greater than 0.1 international units (IU)/mL. Dengue immune participants at Baseline were defined as participants with titers &gt;=10 (1/dilution) for at least one serotype with the parental dengue virus strain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants</measure>
    <time_frame>28 days after first CYD dengue vaccination</time_frame>
    <description>The GMTs against each of the four parenteral dengue virus serotypes (1, 2, 3 and 4) of CYD dengue vaccine were assessed using the 50% plaque reduction neutralization test (PRNT50) assay method. Dengue immune participants at Baseline were defined as participants with titers &gt;=10 (1/dilution) for at least one serotype with the parental dengue virus strain. Titers were measured in terms of 1/dilution.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants</measure>
    <time_frame>Baseline (Pre-CYD vaccination 1) and 28 days after the first CYD dengue vaccination</time_frame>
    <description>The GMTs against each of the four parenteral dengue virus serotypes (1, 2, 3 and 4) of CYD dengue vaccine were assessed using PRNT50 assay method. Dengue immune participants at Baseline were defined as participants with titers &gt;=10 (1/dilution) for at least one serotype with the parental dengue virus strain. Titers were measured in terms of 1/dilution.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Neutralizing Antibody Titers Against Each of the 4 Dengue Virus Serotypes of CYD at Baseline and 28 Days After First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants</measure>
    <time_frame>Baseline (Pre-CYD vaccination 1) and 28 days after the first CYD dengue vaccination</time_frame>
    <description>The GMTs against each of the four parenteral dengue virus serotypes (1, 2, 3 and 4) of CYD dengue vaccine were assessed using PRNT50 assay method. Dengue immune participants at Baseline were defined as participants with titers &gt;=10 (1/dilution) 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 Predefined Thresholds Against at Least 1, 2, 3, or 4 Serotypes of CYD at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants</measure>
    <time_frame>Baseline (Pre-CYD vaccination 1) and 28 days after the first CYD dengue vaccination</time_frame>
    <description>Dengue neutralizing antibody levels against each of the 4 dengue virus serotypes (1, 2, 3, and 4) were measured by PRNT50. Dengue immune participants at Baseline were defined as participants with titers &gt;=10 (1/dilution) for at least one serotype with the parental dengue virus strain. Percentage of participants with neutralizing antibody titers above pre-defined thresholds (&gt;=10 and &gt;=100 [1/dilution]) against at least 1, 2, 3, or 4 serotypes of CYD were reported. Here, 'dil'=dilution and &quot;vac&quot;=vaccination in the specified categories.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Concentrations of Serum Antibodies Against Pertussis Antigens (Pertussis Toxoid, Filamentous Hemagglutinin, Pertactin, and Fimbriae 2+3) at Baseline and 28 Days After the Dose of Tdap Vaccine in the Previously Dengue Immune Participants</measure>
    <time_frame>Baseline (Pre-Tdap vaccination) and 28 days after the Tdap vaccination</time_frame>
    <description>GMCs against each pertussis antigens (PT, FHA, PRN, FIM2+3) were assessed using ELISA assay method and were measured in EU/mL. Dengue immune participants at Baseline were defined as participants with titers &gt;=10 (1/dilution) for at least one serotype with the parental dengue virus strain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Serum Antibody (&gt;=0.1 IU/mL) Against Diphtheria and Tetanus Antigens at Baseline and 28 Days After the Dose of Tdap Vaccine in the Previously Dengue Immune Participants</measure>
    <time_frame>Baseline (Pre-Tdap vaccination) and 28 days after the dose of Tdap vaccination</time_frame>
    <description>The GMC against diphtheria and tetanus antigens was performed by MIT-TNA and ELISA, respectively. Dengue immune participants at Baseline were defined as participants with titers &gt;=10 (1/dilution) for at least one serotype with the parental dengue virus strain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Immediate Unsolicited Adverse Events (AE) Following Vaccination With Tdap or CYD Dengue Vaccine</measure>
    <time_frame>Within 30 minutes after any and each vaccination</time_frame>
    <description>An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the electronic case report form (eCRF) in terms of diagnosis and/or onset post-vaccination. Any unsolicited AE occurred during first 30 minutes post-vaccination was recorded on the CRF as immediate AE. At Visit 1, participants of Group 1 received no vaccination and participants of Group 2 received only Tdap vaccination. At Visit 2, participants of Group 1 received both CYD and Tdap vaccination and participants of Group 2 received only CYD vaccination. At Visit 4, participants of Groups 1 and 2 received CYD vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Solicited Injection Site Reactions Following Vaccination With Tdap or CYD Dengue Vaccine</measure>
    <time_frame>Within 7 days after any and each vaccination</time_frame>
    <description>A solicited reaction (SR) was an AE observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the eCRF and considered as related to vaccination. Solicited injection site reactions included pain, erythema, and swelling. At Visit 1, participants of Group 1 received no vaccination and participants of Group 2 received only Tdap vaccination. At Visit 2, participants of Group 1 received both CYD and Tdap vaccinations and participants of Group 2 received only CYD vaccination. At Visit 4, participants of Groups 1 and 2 received only CYD vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine</measure>
    <time_frame>Within 14 days after any and each vaccination</time_frame>
    <description>A SR reaction was an AE observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the CRF and considered as related to vaccination. Solicited injection site reactions included fever, headache, malaise, myalgia, and asthenia. At Visit 1, participants of Group 1 received no vaccination and participants of Group 2 received only Tdap vaccination. At Visit 2, participants of Group 1 received both CYD and Tdap vaccinations and participants of Group 2 received only CYD vaccination. At Visit 4, participants of Groups 1 and 2 received only CYD vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Reporting Unsolicited Adverse Events Following Vaccination With Tdap or CYD Dengue Vaccine</measure>
    <time_frame>Within 28 days after any and each vaccination</time_frame>
    <description>An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF in terms of diagnosis and/or onset post-vaccination. At Visit 1, participants of Group 1 received no vaccination and participants of Group 2 received only Tdap vaccination. At Visit 2, participants of Group 1 received both CYD and Tdap vaccinations and participants of Group 2 received only CYD vaccination. At Visit 4, participants of Groups 1 and 2 received CYD vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Reporting Non-serious Adverse Event of Special Interests (AESIs) Following Vaccination With Tdap or CYD Dengue Vaccine</measure>
    <time_frame>Within 7 days post any and each vaccination</time_frame>
    <description>Non-serious AESIs were non-serious AEs that were considered by the Sponsor to be relevant for the monitoring of the safety profile of the investigational vaccine. At Visit 1, participants of Group 1 received no vaccination and participants of Group 2 received only Tdap vaccination. At Visit 2, participants of Group 1 received both CYD and Tdap vaccinations and participants of Group 2 received only CYD vaccination. At Visit 4, participants of Groups 1 and 2 received CYD vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Reporting Serious Adverse Events (SAEs) and Serious AESIs Following Vaccination With Tdap or CYD Dengue Vaccine</measure>
    <time_frame>From Day 0 up to 6 months after the last Tdap or CYD vaccination</time_frame>
    <description>SAEs were AEs resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; required hospitalization or prolonged existing hospitalization; persistent or significant disability/incapacity; congenital anomaly or a medically important event. Serious AESIs were SAEs 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 Tdap or CYD Dengue Vaccine</measure>
    <time_frame>From Day 0 up to 6 months after the last Tdap or CYD 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">688</enrollment>
  <condition>Dengue Fever</condition>
  <condition>Dengue Hemorrhagic Fever</condition>
  <arm_group>
    <arm_group_label>Concomitant Administration Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be administered the first dose of CYD dengue vaccine concomitantly with a dose of Tdap vaccine.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequential Administration Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be administered the first dose of CYD dengue vaccine 28 days after a dose of Tdap vaccine.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>CYD Dengue Vaccine</intervention_name>
    <description>0.5 milliliter (mL), Subcutaneous at Month 1, 7 and Month 13, respectively</description>
    <arm_group_label>Concomitant Administration Group</arm_group_label>
    <arm_group_label>Sequential Administration Group</arm_group_label>
    <other_name>Dengvaxia®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Tdap: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine adsorbed</intervention_name>
    <description>0.5 mL, intramuscularly (IM) at Month 1.</description>
    <arm_group_label>Concomitant Administration Group</arm_group_label>
    <other_name>Adacel®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Tdap: Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed</intervention_name>
    <description>0.5 mL, intramuscularly at Day 0.</description>
    <arm_group_label>Sequential Administration Group</arm_group_label>
    <other_name>Adacel®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant aged 9 to 60 years (i.e., from the day of the 9th birthday to the day&#xD;
             prior to the 61th birthday) on the day of inclusion.&#xD;
&#xD;
          -  Participant in good health, based on medical history and physical examination.&#xD;
&#xD;
          -  Informed consent form (ICF) or assent form was signed and dated by the participant&#xD;
             (based on local regulations), and/or ICF was signed and dated by the parent(s) or&#xD;
             another legally acceptable representative (and by an independent witness if required&#xD;
             by local regulations).&#xD;
&#xD;
          -  For participant aged 9 to 11 years: known (documented) receipt of at least 4 previous&#xD;
             doses of diphtheria toxoid, tetanus toxoid and acellular pertussis-containing (DTaP)&#xD;
             vaccines, with the last dose not within the last 5 years prior to enrolment.&#xD;
&#xD;
        OR For participant aged at least 12 years: known (documented or self-reported) receipt of&#xD;
        at least 3 previous doses of diphtheria toxoid, tetanus toxoid, and whole cell&#xD;
        pertussis-containing (DTwP) vaccines, with the last dose not within the last 5 years prior&#xD;
        to enrolment.&#xD;
&#xD;
          -  Participant (or participant and parent[s]/legally acceptable representatives) was able&#xD;
             to attend all scheduled visits and complied with all trial procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participant was pregnant, or lactating, or of childbearing potential (to be considered&#xD;
             of non-childbearing potential, a female must be pre-menarche or post-menopausal for at&#xD;
             least 1 year, surgically sterile, or using an effective method of contraception or&#xD;
             abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks&#xD;
             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 CYD dengue vaccine.&#xD;
&#xD;
          -  Receipt of immune globulins, blood or blood-derived products in the past 3 months,&#xD;
             which might interfere with assessment of the immune response.&#xD;
&#xD;
          -  Known or suspected congenital or acquired immunodeficiency (including human&#xD;
             immunodeficiency virus (HIV) infection with impaired immune function); or receipt of&#xD;
             immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within&#xD;
             the preceding 6 months; or long-term systemic corticosteroids therapy (prednisone or&#xD;
             equivalent for more than 2 consecutive weeks within the past 3 months).&#xD;
&#xD;
          -  A previous severe reaction to pertussis, diphtheria or tetanus vaccine including&#xD;
             immediate anaphylaxis, encephalopathy within 7 days or seizure within 3 days of&#xD;
             receiving the vaccine.&#xD;
&#xD;
          -  Known systemic hypersensitivity to any of the vaccine components, or history of a&#xD;
             life-threatening reaction to the vaccine 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 within 3 weeks preceding inclusion,&#xD;
             which might be a contraindication for IM vaccination, at the discretion of the&#xD;
             Investigator.&#xD;
&#xD;
          -  Deprived of freedom by administrative or court order, or in an emergency setting, or&#xD;
             hospitalized involuntarily.&#xD;
&#xD;
          -  Current alcohol abuse or drug addiction that, based on Investigator's judgment, may&#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 HIV, Hepatitis B, or Hepatitis C infection.&#xD;
&#xD;
          -  Personal history of Guillain-Barré syndrome.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>60 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>Muntinlupa</city>
        <state>Alabang</state>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Manila</city>
        <zip>1000</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Quezon City</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Quezon</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Philippines</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <results_first_submitted>August 11, 2020</results_first_submitted>
  <results_first_submitted_qc>August 11, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">August 27, 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>CYD Dengue Vaccine</keyword>
  <keyword>Dengavaxia®</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>January 4, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/18/NCT02992418/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 19, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/18/NCT02992418/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Study participants were enrolled from 19 December 2016 to 17 April 2017 at 4 centers in the Philippines. A total of 688 participants were enrolled and randomized in this study.</recruitment_details>
      <pre_assignment_details>Safety signal was spotted in dengue non-immune participants, which led to IDMC suggestion to not vaccinate them anymore. As no Health Authority feedback was received on amendment, study was terminated before 3rd (last) injection of CYD dengue vaccine. Hence, no participants received 3rd CYD dengue dose (as planned) and all were followed for safety.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)</title>
          <description>Participants received 1 booster dose of Tetanus Toxoid (T), Reduced Diphtheria Toxoid (D) and Acellular Pertussis Vaccine Adsorbed (ap) (Tdap) vaccine 0.5 milliliter (mL) intramuscular (IM) injection at Month 1, and 2 doses of CYD dengue vaccine 0.5 mL subcutaneous (SC) injection at Month 1 (concomitantly with Tdap booster dose) and at Month 7.</description>
        </group>
        <group group_id="P2">
          <title>CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)</title>
          <description>Participants received 1 booster dose of Tdap vaccine 0.5 mL IM injection at Day 0 and 2 doses of CYD dengue vaccine 0.5 mL SC injection at Month 1 (sequentially, one month after the Tdap booster dose) and at Month 7.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="346"/>
                <participants group_id="P2" count="342"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Analysis Set (SafAS)</title>
              <participants_list>
                <participants group_id="P1" count="338"/>
                <participants group_id="P2" count="342"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="346"/>
                <participants group_id="P2" count="342"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-compliance with the protocol</title>
              <participants_list>
                <participants group_id="P1" count="308"/>
                <participants group_id="P2" count="308"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Analysis was performed on all randomized participants.</population>
      <group_list>
        <group group_id="B1">
          <title>CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)</title>
          <description>Participants received 1 booster dose of Tdap vaccine 0.5 mL IM injection at Month 1, and 2 doses of CYD dengue vaccine 0.5 mL SC injection at Month 1 (concomitantly with Tdap booster dose) and at Month 7.</description>
        </group>
        <group group_id="B2">
          <title>CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)</title>
          <description>Participants received 1 booster dose of Tdap vaccine 0.5 mL IM injection at Day 0 and 2 doses of CYD dengue vaccine 0.5 mL SC injection at Month 1 (sequentially, one month after the Tdap booster dose) and at Month 7.</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="346"/>
            <count group_id="B2" value="342"/>
            <count group_id="B3" value="688"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="346"/>
                    <count group_id="B2" value="342"/>
                    <count group_id="B3" value="688"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.2" spread="16.3"/>
                    <measurement group_id="B2" value="27.1" spread="16.7"/>
                    <measurement group_id="B3" value="26.6" spread="16.5"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="346"/>
                    <count group_id="B2" value="342"/>
                    <count group_id="B3" value="688"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="187"/>
                    <measurement group_id="B2" value="193"/>
                    <measurement group_id="B3" value="380"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="159"/>
                    <measurement group_id="B2" value="149"/>
                    <measurement group_id="B3" value="308"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Dengue Baseline Status</title>
          <description>Dengue immune participants were defined as participants with titers greater than or equal to (&gt;=) 10 (1/dilution) for at least one serotype with the parental dengue virus strain. Dengue non-immune participants were defined as participants with titers less than (&lt;) 10 (1/dilution) for all serotypes with parental dengue virus strains with available and 'valid' results.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Dengue immune</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="346"/>
                    <count group_id="B2" value="342"/>
                    <count group_id="B3" value="688"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="314"/>
                    <measurement group_id="B2" value="315"/>
                    <measurement group_id="B3" value="629"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dengue non-immune</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="346"/>
                    <count group_id="B2" value="342"/>
                    <count group_id="B3" value="688"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Geometric Mean Concentrations (GMCs) of Antibodies Against Pertussis Antigens (Pertussis Toxoid, Filamentous Hemagglutinin, Pertactin, and Fimbriae 2+3) 28 Days After Dose of Tdap Vaccine in Previously Dengue Immune Participants</title>
        <description>GMCs against each pertussis antigens (pertussis toxoid [PT], filamentous hemagglutinin [FHA], pertactin [PRN], fimbriae types 2 and 3 [FIM2+3]) were assessed using an enzyme-linked immunosorbent assay (ELISA) method and were measured in ELISA unit/milliliter (EU/mL). Dengue immune participants at Baseline were defined as participants with titers &gt;=10 (1/dilution) for at least one serotype with the parental dengue virus strain.</description>
        <time_frame>28 days after Tdap vaccination</time_frame>
        <population>Per protocol analysis set of Tdap (PPT) included dengue immune participants who received at least one dose of Tdap and had no relevant protocol deviations. Here, 'Number analyzed' = participants with available data for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)</title>
            <description>Participants received 1 booster dose of Tdap vaccine 0.5 mL IM injection at Month 1, and 2 doses of CYD dengue vaccine 0.5 mL SC injection at Month 1 (concomitantly with Tdap booster dose) and at Month 7.</description>
          </group>
          <group group_id="O2">
            <title>CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)</title>
            <description>Participants received 1 booster dose of Tdap vaccine 0.5 mL IM injection at Day 0 and 2 doses of CYD dengue vaccine 0.5 mL SC injection at Month 1 (sequentially, one month after the Tdap booster dose) and at Month 7.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Concentrations (GMCs) of Antibodies Against Pertussis Antigens (Pertussis Toxoid, Filamentous Hemagglutinin, Pertactin, and Fimbriae 2+3) 28 Days After Dose of Tdap Vaccine in Previously Dengue Immune Participants</title>
          <description>GMCs against each pertussis antigens (pertussis toxoid [PT], filamentous hemagglutinin [FHA], pertactin [PRN], fimbriae types 2 and 3 [FIM2+3]) were assessed using an enzyme-linked immunosorbent assay (ELISA) method and were measured in ELISA unit/milliliter (EU/mL). Dengue immune participants at Baseline were defined as participants with titers &gt;=10 (1/dilution) for at least one serotype with the parental dengue virus strain.</description>
          <population>Per protocol analysis set of Tdap (PPT) included dengue immune participants who received at least one dose of Tdap and had no relevant protocol deviations. Here, 'Number analyzed' = participants with available data for each specified category.</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="312"/>
                <count group_id="O2" value="314"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Anti-PT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="300"/>
                    <count group_id="O2" value="310"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.2" lower_limit="57.7" upper_limit="73.8"/>
                    <measurement group_id="O2" value="76.0" lower_limit="67.9" upper_limit="85.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anti-FHA</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="308"/>
                    <count group_id="O2" value="314"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="273" lower_limit="248" upper_limit="299"/>
                    <measurement group_id="O2" value="267" lower_limit="241" upper_limit="296"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anti-PRN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="311"/>
                    <count group_id="O2" value="314"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.6" lower_limit="41.4" upper_limit="61.9"/>
                    <measurement group_id="O2" value="44.9" lower_limit="36.7" upper_limit="55.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anti-FIM2+3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="309"/>
                    <count group_id="O2" value="312"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="705" lower_limit="586" upper_limit="847"/>
                    <measurement group_id="O2" value="643" lower_limit="537" upper_limit="770"/>
                  </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>Anti-PT</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority was demonstrated if the lower limit of the two-sided 95% confidence interval (CI) of the ratio of GMCs between groups (Group 1/ Group 2) was greater than (&gt;) 1/1.5 for each antigen. Overall non-inferiority was demonstrated if the 4 antigens achieved non-inferiority.</non_inferiority_desc>
            <param_type>GMC ratio</param_type>
            <param_value>0.848</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.721</ci_lower_limit>
            <ci_upper_limit>0.997</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Anti-FHA</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMCs between groups (Group 1/ Group 2) was &gt; 1/1.5 for each antigen. Overall non-inferiority was demonstrated if the 4 antigens achieved non-inferiority.</non_inferiority_desc>
            <param_type>GMC ratio</param_type>
            <param_value>1.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.892</ci_lower_limit>
            <ci_upper_limit>1.18</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Anti-PRN</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMCs between groups (Group 1/ Group 2) was &gt; 1/1.5 for each antigen. Overall non-inferiority was demonstrated if the 4 antigens achieved non-inferiority.</non_inferiority_desc>
            <param_type>GMC ratio</param_type>
            <param_value>1.11</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.836</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>Anti-FIM2+3</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMCs between groups (Group 1/ Group 2) was &gt; 1/1.5 for each antigen. Overall non-inferiority was demonstrated if the 4 antigens achieved non-inferiority.</non_inferiority_desc>
            <param_type>GMC ratio</param_type>
            <param_value>1.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.827</ci_lower_limit>
            <ci_upper_limit>1.33</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens 28 Days After the Dose of Tdap Vaccine in the Previously Dengue Immune Participants</title>
        <description>Seroprotection against diphtheria (Anti-D) and tetanus (Anti-T) antigens was performed by Micrometabolic Inhibition Test - Toxin Neutralization assay (MIT-TNA) and ELISA, respectively. Seroprotection was defined as anti-D and anti-T Ab concentration greater than 0.1 international units (IU)/mL. Dengue immune participants at Baseline were defined as participants with titers &gt;=10 (1/dilution) for at least one serotype with the parental dengue virus strain.</description>
        <time_frame>28 days after Tdap vaccination</time_frame>
        <population>Analysis was performed on PPT population. Here, 'Number analyzed' = participants with available data for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)</title>
            <description>Participants received 1 booster dose of Tdap vaccine 0.5 mL IM injection at Month 1, and 2 doses of CYD dengue vaccine 0.5 mL SC injection at Month 1 (concomitantly with Tdap booster dose) and at Month 7.</description>
          </group>
          <group group_id="O2">
            <title>CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)</title>
            <description>Participants received 1 booster dose of Tdap vaccine 0.5 mL IM injection at Day 0 and 2 doses of CYD dengue vaccine 0.5 mL SC injection at Month 1 (sequentially, one month after the Tdap booster dose) and at Month 7.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens 28 Days After the Dose of Tdap Vaccine in the Previously Dengue Immune Participants</title>
          <description>Seroprotection against diphtheria (Anti-D) and tetanus (Anti-T) antigens was performed by Micrometabolic Inhibition Test - Toxin Neutralization assay (MIT-TNA) and ELISA, respectively. Seroprotection was defined as anti-D and anti-T Ab concentration greater than 0.1 international units (IU)/mL. Dengue immune participants at Baseline were defined as participants with titers &gt;=10 (1/dilution) for at least one serotype with the parental dengue virus strain.</description>
          <population>Analysis was performed on PPT population. Here, 'Number analyzed' = participants with available data for each specified category.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="312"/>
                <count group_id="O2" value="314"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Anti-D</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="312"/>
                    <count group_id="O2" value="314"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.1" lower_limit="86.2" upper_limit="93.1"/>
                    <measurement group_id="O2" value="89.8" lower_limit="85.9" upper_limit="92.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anti-T</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="309"/>
                    <count group_id="O2" value="314"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.4" lower_limit="96.3" upper_limit="99.5"/>
                    <measurement group_id="O2" value="99.0" lower_limit="97.2" upper_limit="99.8"/>
                  </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>Anti-D</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The non-inferiority was demonstrated if the lower limit of all the 95% CI of the percentage difference was &gt; -10% for all antigens.</non_inferiority_desc>
            <param_type>Percentage difference</param_type>
            <param_value>0.26</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.53</ci_lower_limit>
            <ci_upper_limit>5.04</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Anti-T</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The non-inferiority was demonstrated if the lower limit of all the 95% CI of the percentage difference was &gt; -10% for all antigens.</non_inferiority_desc>
            <param_type>Percentage difference</param_type>
            <param_value>-0.66</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.87</ci_lower_limit>
            <ci_upper_limit>1.37</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants</title>
        <description>The GMTs against each of the four parenteral dengue virus serotypes (1, 2, 3 and 4) of CYD dengue vaccine were assessed using the 50% plaque reduction neutralization test (PRNT50) assay method. Dengue immune participants at Baseline were defined as participants with titers &gt;=10 (1/dilution) for at least one serotype with the parental dengue virus strain. Titers were measured in terms of 1/dilution.</description>
        <time_frame>28 days after first CYD dengue vaccination</time_frame>
        <population>Analysis was performed on per-protocol analysis set for CYD dengue vaccine (PPC) population which included dengue immune participants who received 1st dose of CYD dengue vaccine and had no relevant protocol deviations.</population>
        <group_list>
          <group group_id="O1">
            <title>CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)</title>
            <description>Participants received 1 booster dose of Tdap vaccine 0.5 mL IM injection at Month 1, and 2 doses of CYD dengue vaccine 0.5 mL SC injection at Month 1 (concomitantly with Tdap booster dose) and at Month 7.</description>
          </group>
          <group group_id="O2">
            <title>CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)</title>
            <description>Participants received 1 booster dose of Tdap vaccine 0.5 mL IM injection at Day 0 and 2 doses of CYD dengue vaccine 0.5 mL SC injection at Month 1 (sequentially, one month after the Tdap booster dose) and at Month 7.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants</title>
          <description>The GMTs against each of the four parenteral dengue virus serotypes (1, 2, 3 and 4) of CYD dengue vaccine were assessed using the 50% plaque reduction neutralization test (PRNT50) assay method. Dengue immune participants at Baseline were defined as participants with titers &gt;=10 (1/dilution) for at least one serotype with the parental dengue virus strain. Titers were measured in terms of 1/dilution.</description>
          <population>Analysis was performed on per-protocol analysis set for CYD dengue vaccine (PPC) population which included dengue immune participants who received 1st dose of CYD dengue vaccine and had no relevant protocol deviations.</population>
          <units>titers</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="312"/>
                <count group_id="O2" value="308"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serotype 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="513" lower_limit="427" upper_limit="617"/>
                    <measurement group_id="O2" value="461" lower_limit="384" upper_limit="552"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="677" lower_limit="588" upper_limit="780"/>
                    <measurement group_id="O2" value="568" lower_limit="489" upper_limit="661"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="653" lower_limit="558" upper_limit="765"/>
                    <measurement group_id="O2" value="706" lower_limit="603" upper_limit="828"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="378" lower_limit="324" upper_limit="442"/>
                    <measurement group_id="O2" value="472" lower_limit="404" upper_limit="551"/>
                  </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>Serotype 1</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 1/Group 2) was &gt; 1/2 for each serotype. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.</non_inferiority_desc>
            <param_type>GMT ratio</param_type>
            <param_value>1.11</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.862</ci_lower_limit>
            <ci_upper_limit>1.44</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serotype 2</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 1/Group 2) was &gt; 1/2 for each serotype. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.</non_inferiority_desc>
            <param_type>GMT ratio</param_type>
            <param_value>1.19</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.97</ci_lower_limit>
            <ci_upper_limit>1.47</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serotype 3</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 1/Group 2) was &gt; 1/2 for each serotype. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.</non_inferiority_desc>
            <param_type>GMT ratio</param_type>
            <param_value>0.925</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.739</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>Serotype 4</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 1/Group 2) was &gt; 1/2 for each serotype. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.</non_inferiority_desc>
            <param_type>GMT ratio</param_type>
            <param_value>0.802</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.644</ci_lower_limit>
            <ci_upper_limit>0.999</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants</title>
        <description>The GMTs against each of the four parenteral dengue virus serotypes (1, 2, 3 and 4) of CYD dengue vaccine were assessed using PRNT50 assay method. Dengue immune participants at Baseline were defined as participants with titers &gt;=10 (1/dilution) for at least one serotype with the parental dengue virus strain. Titers were measured in terms of 1/dilution.</description>
        <time_frame>Baseline (Pre-CYD vaccination 1) and 28 days after the first CYD dengue vaccination</time_frame>
        <population>Analysis was performed on the subset of participants who received at least one dose of study vaccines (CYD dengue or Tdap) and were immune to dengue at baseline. Here, 'Number analyzed' = participants with available data for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)</title>
            <description>Participants received 1 booster dose of Tdap vaccine 0.5 mL IM injection at Month 1, and 2 doses of CYD dengue vaccine 0.5 mL SC injection at Month 1 (concomitantly with Tdap booster dose) and at Month 7.</description>
          </group>
          <group group_id="O2">
            <title>CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)</title>
            <description>Participants received 1 booster dose of Tdap vaccine 0.5 mL IM injection at Day 0 and 2 doses of CYD dengue vaccine 0.5 mL SC injection at Month 1 (sequentially, one month after the Tdap booster dose) and at Month 7.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants</title>
          <description>The GMTs against each of the four parenteral dengue virus serotypes (1, 2, 3 and 4) of CYD dengue vaccine were assessed using PRNT50 assay method. Dengue immune participants at Baseline were defined as participants with titers &gt;=10 (1/dilution) for at least one serotype with the parental dengue virus strain. Titers were measured in terms of 1/dilution.</description>
          <population>Analysis was performed on the subset of participants who received at least one dose of study vaccines (CYD dengue or Tdap) and were immune to dengue at baseline. Here, 'Number analyzed' = participants with available data for each specified category.</population>
          <units>titers</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="314"/>
                <count group_id="O2" value="315"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serotype 1: Pre-vaccination 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="314"/>
                    <count group_id="O2" value="315"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="265" lower_limit="218" upper_limit="322"/>
                    <measurement group_id="O2" value="250" lower_limit="208" upper_limit="300"/>
                  </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="313"/>
                    <count group_id="O2" value="315"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="513" lower_limit="427" upper_limit="616"/>
                    <measurement group_id="O2" value="468" lower_limit="392" upper_limit="560"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 2: Pre-vaccination 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="314"/>
                    <count group_id="O2" value="315"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="404" lower_limit="350" upper_limit="467"/>
                    <measurement group_id="O2" value="343" lower_limit="294" upper_limit="401"/>
                  </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="313"/>
                    <count group_id="O2" value="315"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="679" lower_limit="589" upper_limit="781"/>
                    <measurement group_id="O2" value="577" lower_limit="497" upper_limit="671"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 3: Pre-vaccination 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="314"/>
                    <count group_id="O2" value="315"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="327" lower_limit="274" upper_limit="391"/>
                    <measurement group_id="O2" value="327" lower_limit="280" upper_limit="383"/>
                  </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="313"/>
                    <count group_id="O2" value="315"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="655" lower_limit="559" upper_limit="767"/>
                    <measurement group_id="O2" value="709" lower_limit="605" upper_limit="830"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 4: Pre-vaccination 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="314"/>
                    <count group_id="O2" value="315"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="136" lower_limit="115" upper_limit="160"/>
                    <measurement group_id="O2" value="172" lower_limit="150" upper_limit="197"/>
                  </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="313"/>
                    <count group_id="O2" value="315"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="379" lower_limit="325" upper_limit="443"/>
                    <measurement group_id="O2" value="478" lower_limit="410" upper_limit="557"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Neutralizing Antibody Titers Against Each of the 4 Dengue Virus Serotypes of CYD at Baseline and 28 Days After First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants</title>
        <description>The GMTs against each of the four parenteral dengue virus serotypes (1, 2, 3 and 4) of CYD dengue vaccine were assessed using PRNT50 assay method. Dengue immune participants at Baseline were defined as participants with titers &gt;=10 (1/dilution) for at least one serotype with the parental dengue virus strain.</description>
        <time_frame>Baseline (Pre-CYD vaccination 1) and 28 days after the first CYD dengue vaccination</time_frame>
        <population>Analysis was performed on the subset of participants who received at least one dose of study vaccines (CYD dengue or Tdap) and were immune to dengue at baseline. Here, 'Number analyzed' = participants with available data for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)</title>
            <description>Participants received 1 booster dose of Tdap vaccine 0.5 mL IM injection at Month 1, and 2 doses of CYD dengue vaccine 0.5 mL SC injection at Month 1 (concomitantly with Tdap booster dose) and at Month 7.</description>
          </group>
          <group group_id="O2">
            <title>CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)</title>
            <description>Participants received 1 booster dose of Tdap vaccine 0.5 mL IM injection at Day 0 and 2 doses of CYD dengue vaccine 0.5 mL SC injection at Month 1 (sequentially, one month after the Tdap booster dose) and at Month 7.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Neutralizing Antibody Titers Against Each of the 4 Dengue Virus Serotypes of CYD at Baseline and 28 Days After First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants</title>
          <description>The GMTs against each of the four parenteral dengue virus serotypes (1, 2, 3 and 4) of CYD dengue vaccine were assessed using PRNT50 assay method. Dengue immune participants at Baseline were defined as participants with titers &gt;=10 (1/dilution) for at least one serotype with the parental dengue virus strain.</description>
          <population>Analysis was performed on the subset of participants who received at least one dose of study vaccines (CYD dengue or Tdap) and were immune to dengue at baseline. Here, 'Number analyzed' = participants with available data for each specified category.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="314"/>
                <count group_id="O2" value="315"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serotype 1: Pre-vaccination 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="314"/>
                    <count group_id="O2" value="315"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.7" lower_limit="89.2" upper_limit="95.3"/>
                    <measurement group_id="O2" value="93.3" lower_limit="90.0" upper_limit="95.8"/>
                  </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="313"/>
                    <count group_id="O2" value="315"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.8" lower_limit="95.4" upper_limit="99.1"/>
                    <measurement group_id="O2" value="98.4" lower_limit="96.3" upper_limit="99.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 2: Pre-vaccination 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="314"/>
                    <count group_id="O2" value="315"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.1" lower_limit="95.9" upper_limit="99.3"/>
                    <measurement group_id="O2" value="96.5" lower_limit="93.8" upper_limit="98.2"/>
                  </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="313"/>
                    <count group_id="O2" value="315"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="98.8" upper_limit="100.0"/>
                    <measurement group_id="O2" value="99.0" lower_limit="97.2" upper_limit="99.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 3: Pre-vaccination 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="314"/>
                    <count group_id="O2" value="315"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.5" lower_limit="92.6" upper_limit="97.5"/>
                    <measurement group_id="O2" value="97.1" lower_limit="94.6" upper_limit="98.7"/>
                  </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="313"/>
                    <count group_id="O2" value="315"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="98.8" upper_limit="100.0"/>
                    <measurement group_id="O2" value="99.7" lower_limit="98.2" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 4: Pre-vaccination 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="314"/>
                    <count group_id="O2" value="315"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.0" lower_limit="89.6" upper_limit="95.6"/>
                    <measurement group_id="O2" value="97.5" lower_limit="95.1" upper_limit="98.9"/>
                  </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="313"/>
                    <count group_id="O2" value="315"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.4" lower_limit="97.7" upper_limit="99.9"/>
                    <measurement group_id="O2" value="100.0" lower_limit="98.8" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Neutralizing Antibody Titers Above Predefined Thresholds Against at Least 1, 2, 3, or 4 Serotypes of CYD at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants</title>
        <description>Dengue neutralizing antibody levels against each of the 4 dengue virus serotypes (1, 2, 3, and 4) were measured by PRNT50. Dengue immune participants at Baseline were defined as participants with titers &gt;=10 (1/dilution) for at least one serotype with the parental dengue virus strain. Percentage of participants with neutralizing antibody titers above pre-defined thresholds (&gt;=10 and &gt;=100 [1/dilution]) against at least 1, 2, 3, or 4 serotypes of CYD were reported. Here, 'dil'=dilution and &quot;vac&quot;=vaccination in the specified categories.</description>
        <time_frame>Baseline (Pre-CYD vaccination 1) and 28 days after the first CYD dengue vaccination</time_frame>
        <population>Analysis was performed on subset of participants who received at least one dose of study vaccines (CYD dengue or Tdap) and were immune to dengue at baseline. Here, 'Number analyzed' = participants with available data for each specified categories.</population>
        <group_list>
          <group group_id="O1">
            <title>CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)</title>
            <description>Participants received 1 booster dose of Tdap vaccine 0.5 mL IM injection at Month 1, and 2 doses of CYD dengue vaccine 0.5 mL SC injection at Month 1 (concomitantly with Tdap booster dose) and at Month 7.</description>
          </group>
          <group group_id="O2">
            <title>CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)</title>
            <description>Participants received 1 booster dose of Tdap vaccine 0.5 mL IM injection at Day 0 and 2 doses of CYD dengue vaccine 0.5 mL SC injection at Month 1 (sequentially, one month after the Tdap booster dose) and at Month 7.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Neutralizing Antibody Titers Above Predefined Thresholds Against at Least 1, 2, 3, or 4 Serotypes of CYD at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants</title>
          <description>Dengue neutralizing antibody levels against each of the 4 dengue virus serotypes (1, 2, 3, and 4) were measured by PRNT50. Dengue immune participants at Baseline were defined as participants with titers &gt;=10 (1/dilution) for at least one serotype with the parental dengue virus strain. Percentage of participants with neutralizing antibody titers above pre-defined thresholds (&gt;=10 and &gt;=100 [1/dilution]) against at least 1, 2, 3, or 4 serotypes of CYD were reported. Here, 'dil'=dilution and &quot;vac&quot;=vaccination in the specified categories.</description>
          <population>Analysis was performed on subset of participants who received at least one dose of study vaccines (CYD dengue or Tdap) and were immune to dengue at baseline. Here, 'Number analyzed' = participants with available data for each 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="314"/>
                <count group_id="O2" value="315"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At least 1 Serotype: pre-vac 1: &gt;=10 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="314"/>
                    <count group_id="O2" value="315"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="98.8" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100.0" lower_limit="98.8" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least 1 Serotype: pre-vac1: &gt;=100 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="314"/>
                    <count group_id="O2" value="315"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.8" lower_limit="95.5" upper_limit="99.1"/>
                    <measurement group_id="O2" value="97.1" lower_limit="94.6" upper_limit="98.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least 1 Serotype: post-vac 1: &gt;=10 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="313"/>
                    <count group_id="O2" value="315"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="98.8" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100.0" lower_limit="98.8" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least 1 Serotype: post-vac 1: &gt;=100 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="313"/>
                    <count group_id="O2" value="315"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.7" lower_limit="98.2" upper_limit="100.0"/>
                    <measurement group_id="O2" value="99.7" lower_limit="98.2" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least 2 Serotype: pre-vac 1: &gt;=10 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="314"/>
                    <count group_id="O2" value="315"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.5" lower_limit="93.8" upper_limit="98.2"/>
                    <measurement group_id="O2" value="98.1" lower_limit="95.9" upper_limit="99.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least 2 Serotype: pre-vac 1: &gt;=100 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="314"/>
                    <count group_id="O2" value="315"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.4" lower_limit="79.9" upper_limit="88.2"/>
                    <measurement group_id="O2" value="87.0" lower_limit="82.8" upper_limit="90.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least 2 Serotype: post-vac 1: &gt;=10 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="313"/>
                    <count group_id="O2" value="315"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="98.8" upper_limit="100.0"/>
                    <measurement group_id="O2" value="99.7" lower_limit="98.2" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least 2 Serotype: post-vac 1: &gt;=100 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="313"/>
                    <count group_id="O2" value="315"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.8" lower_limit="93.0" upper_limit="97.8"/>
                    <measurement group_id="O2" value="96.5" lower_limit="93.8" upper_limit="98.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least 3 Serotype: pre-vac 1: &gt;=10 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="314"/>
                    <count group_id="O2" value="315"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.6" lower_limit="90.3" upper_limit="96.1"/>
                    <measurement group_id="O2" value="95.2" lower_limit="92.3" upper_limit="97.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least 3 Serotype: pre-vac 1: &gt;=100 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="314"/>
                    <count group_id="O2" value="315"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.1" lower_limit="71.0" upper_limit="80.7"/>
                    <measurement group_id="O2" value="76.8" lower_limit="71.8" upper_limit="81.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least 3 Serotype: post-vac 1: &gt;=10 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="313"/>
                    <count group_id="O2" value="315"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.7" lower_limit="98.2" upper_limit="100.0"/>
                    <measurement group_id="O2" value="99.4" lower_limit="97.7" upper_limit="99.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least 3 Serotype: post-vac 1: &gt;=100 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="313"/>
                    <count group_id="O2" value="315"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.4" lower_limit="86.6" upper_limit="93.4"/>
                    <measurement group_id="O2" value="92.1" lower_limit="88.5" upper_limit="94.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least 4 Serotype: pre-vac 1: &gt;=10 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="314"/>
                    <count group_id="O2" value="315"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.2" lower_limit="85.2" upper_limit="92.4"/>
                    <measurement group_id="O2" value="91.1" lower_limit="87.4" upper_limit="94.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least 4 Serotype: pre-vac 1: &gt;=100 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="314"/>
                    <count group_id="O2" value="315"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.9" lower_limit="47.2" upper_limit="58.5"/>
                    <measurement group_id="O2" value="54.3" lower_limit="48.6" upper_limit="59.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least 4 Serotype: post-vac 1: &gt;=10 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="313"/>
                    <count group_id="O2" value="315"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.4" lower_limit="95.0" upper_limit="98.9"/>
                    <measurement group_id="O2" value="98.1" lower_limit="95.9" upper_limit="99.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least 4 Serotype: post-vac 1: &gt;=100 (1/dil)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="313"/>
                    <count group_id="O2" value="315"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.8" lower_limit="68.6" upper_limit="78.6"/>
                    <measurement group_id="O2" value="75.6" lower_limit="70.4" upper_limit="80.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Concentrations of Serum Antibodies Against Pertussis Antigens (Pertussis Toxoid, Filamentous Hemagglutinin, Pertactin, and Fimbriae 2+3) at Baseline and 28 Days After the Dose of Tdap Vaccine in the Previously Dengue Immune Participants</title>
        <description>GMCs against each pertussis antigens (PT, FHA, PRN, FIM2+3) were assessed using ELISA assay method and were measured in EU/mL. Dengue immune participants at Baseline were defined as participants with titers &gt;=10 (1/dilution) for at least one serotype with the parental dengue virus strain.</description>
        <time_frame>Baseline (Pre-Tdap vaccination) and 28 days after the Tdap vaccination</time_frame>
        <population>Analysis was performed on the subset of participants who received at least one dose of study vaccines (CYD dengue or Tdap) and were immune to dengue at baseline. Here, 'Number analyzed' = participants with available data for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)</title>
            <description>Participants received 1 booster dose of Tdap vaccine 0.5 mL IM injection at Month 1, and 2 doses of CYD dengue vaccine 0.5 mL SC injection at Month 1 (concomitantly with Tdap booster dose) and at Month 7.</description>
          </group>
          <group group_id="O2">
            <title>CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)</title>
            <description>Participants received 1 booster dose of Tdap vaccine 0.5 mL IM injection at Day 0 and 2 doses of CYD dengue vaccine 0.5 mL SC injection at Month 1 (sequentially, one month after the Tdap booster dose) and at Month 7.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Concentrations of Serum Antibodies Against Pertussis Antigens (Pertussis Toxoid, Filamentous Hemagglutinin, Pertactin, and Fimbriae 2+3) at Baseline and 28 Days After the Dose of Tdap Vaccine in the Previously Dengue Immune Participants</title>
          <description>GMCs against each pertussis antigens (PT, FHA, PRN, FIM2+3) were assessed using ELISA assay method and were measured in EU/mL. Dengue immune participants at Baseline were defined as participants with titers &gt;=10 (1/dilution) for at least one serotype with the parental dengue virus strain.</description>
          <population>Analysis was performed on the subset of participants who received at least one dose of study vaccines (CYD dengue or Tdap) and were immune to dengue at baseline. Here, 'Number analyzed' = participants with available data for each specified category.</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="314"/>
                <count group_id="O2" value="315"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Anti-PT: Pre-vaccination</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="313"/>
                    <count group_id="O2" value="313"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.46" lower_limit="7.34" upper_limit="9.75"/>
                    <measurement group_id="O2" value="9.56" lower_limit="8.33" upper_limit="11.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anti-PT: 28 days post-vaccination</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="301"/>
                    <count group_id="O2" value="311"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.0" lower_limit="57.5" upper_limit="73.5"/>
                    <measurement group_id="O2" value="76.1" lower_limit="68.1" upper_limit="85.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anti-FHA: Pre-vaccination</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="310"/>
                    <count group_id="O2" value="314"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.9" lower_limit="17.6" upper_limit="22.6"/>
                    <measurement group_id="O2" value="19.4" lower_limit="17.1" upper_limit="22.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anti-FHA: 28 days post-vaccination</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="309"/>
                    <count group_id="O2" value="315"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="272" lower_limit="248" upper_limit="299"/>
                    <measurement group_id="O2" value="266" lower_limit="240" upper_limit="295"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anti-PRN: Pre-vaccination</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="314"/>
                    <count group_id="O2" value="315"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.79" lower_limit="3.39" upper_limit="4.24"/>
                    <measurement group_id="O2" value="3.65" lower_limit="3.25" upper_limit="4.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anti-PRN: 28 days post-vaccination</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="312"/>
                    <count group_id="O2" value="315"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.6" lower_limit="41.4" upper_limit="61.8"/>
                    <measurement group_id="O2" value="45.0" lower_limit="36.8" upper_limit="55.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anti-FIM2+3: Pre-vaccination</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="297"/>
                    <count group_id="O2" value="298"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.1" lower_limit="12.4" upper_limit="18.5"/>
                    <measurement group_id="O2" value="14.9" lower_limit="12.2" upper_limit="18.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anti-FIM2+3: 28 days post-vaccination</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="310"/>
                    <count group_id="O2" value="313"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="700" lower_limit="583" upper_limit="841"/>
                    <measurement group_id="O2" value="642" lower_limit="537" upper_limit="769"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving Serum Antibody (&gt;=0.1 IU/mL) Against Diphtheria and Tetanus Antigens at Baseline and 28 Days After the Dose of Tdap Vaccine in the Previously Dengue Immune Participants</title>
        <description>The GMC against diphtheria and tetanus antigens was performed by MIT-TNA and ELISA, respectively. Dengue immune participants at Baseline were defined as participants with titers &gt;=10 (1/dilution) for at least one serotype with the parental dengue virus strain.</description>
        <time_frame>Baseline (Pre-Tdap vaccination) and 28 days after the dose of Tdap vaccination</time_frame>
        <population>Analysis was performed on the subset of participants who received at least one dose of study vaccines (CYD dengue or Tdap) and were immune to dengue at baseline. Here, 'Number analyzed' = participants with available data for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)</title>
            <description>Participants received 1 booster dose of Tdap vaccine 0.5 mL IM injection at Month 1, and 2 doses of CYD dengue vaccine 0.5 mL SC injection at Month 1 (concomitantly with Tdap booster dose) and at Month 7.</description>
          </group>
          <group group_id="O2">
            <title>CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)</title>
            <description>Participants received 1 booster dose of Tdap vaccine 0.5 mL IM injection at Day 0 and 2 doses of CYD dengue vaccine 0.5 mL SC injection at Month 1 (sequentially, one month after the Tdap booster dose) and at Month 7.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Serum Antibody (&gt;=0.1 IU/mL) Against Diphtheria and Tetanus Antigens at Baseline and 28 Days After the Dose of Tdap Vaccine in the Previously Dengue Immune Participants</title>
          <description>The GMC against diphtheria and tetanus antigens was performed by MIT-TNA and ELISA, respectively. Dengue immune participants at Baseline were defined as participants with titers &gt;=10 (1/dilution) for at least one serotype with the parental dengue virus strain.</description>
          <population>Analysis was performed on the subset of participants who received at least one dose of study vaccines (CYD dengue or Tdap) and were immune to dengue at baseline. Here, 'Number analyzed' = participants with available data for each specified category.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="314"/>
                <count group_id="O2" value="315"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Anti-D: Pre-vaccination</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="314"/>
                    <count group_id="O2" value="314"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.8" lower_limit="26.7" upper_limit="37.3"/>
                    <measurement group_id="O2" value="32.8" lower_limit="27.6" upper_limit="38.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anti-T: Pre-vaccination</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="314"/>
                    <count group_id="O2" value="313"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.7" lower_limit="58.1" upper_limit="69.0"/>
                    <measurement group_id="O2" value="69.6" lower_limit="64.2" upper_limit="74.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anti-D: 28 days post-vaccination</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="313"/>
                    <count group_id="O2" value="315"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.1" lower_limit="86.2" upper_limit="93.2"/>
                    <measurement group_id="O2" value="89.8" lower_limit="86.0" upper_limit="92.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anti-T: 28 days post-vaccination</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="310"/>
                    <count group_id="O2" value="315"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.1" lower_limit="95.8" upper_limit="99.3"/>
                    <measurement group_id="O2" value="99.0" lower_limit="97.2" upper_limit="99.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Immediate Unsolicited Adverse Events (AE) Following Vaccination With Tdap or CYD Dengue Vaccine</title>
        <description>An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the electronic case report form (eCRF) in terms of diagnosis and/or onset post-vaccination. Any unsolicited AE occurred during first 30 minutes post-vaccination was recorded on the CRF as immediate AE. At Visit 1, participants of Group 1 received no vaccination and participants of Group 2 received only Tdap vaccination. At Visit 2, participants of Group 1 received both CYD and Tdap vaccination and participants of Group 2 received only CYD vaccination. At Visit 4, participants of Groups 1 and 2 received CYD vaccination.</description>
        <time_frame>Within 30 minutes after any and each vaccination</time_frame>
        <population>Analysis was performed on SafAS population, which included participants who received at least one dose of the study vaccines (CYD dengue or Tdap). Here, 'Number analyzed' = participants with available data for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)</title>
            <description>Participants received 1 booster dose of Tdap vaccine 0.5 mL IM injection at Month 1, and 2 doses of CYD dengue vaccine 0.5 mL SC injection at Month 1 (concomitantly with Tdap booster dose) and at Month 7.</description>
          </group>
          <group group_id="O2">
            <title>CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)</title>
            <description>Participants received 1 booster dose of Tdap vaccine 0.5 mL IM injection at Day 0 and 2 doses of CYD dengue vaccine 0.5 mL SC injection at Month 1 (sequentially, one month after the Tdap booster dose) and at Month 7.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Immediate Unsolicited Adverse Events (AE) Following Vaccination With Tdap or CYD Dengue Vaccine</title>
          <description>An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the electronic case report form (eCRF) in terms of diagnosis and/or onset post-vaccination. Any unsolicited AE occurred during first 30 minutes post-vaccination was recorded on the CRF as immediate AE. At Visit 1, participants of Group 1 received no vaccination and participants of Group 2 received only Tdap vaccination. At Visit 2, participants of Group 1 received both CYD and Tdap vaccination and participants of Group 2 received only CYD vaccination. At Visit 4, participants of Groups 1 and 2 received CYD vaccination.</description>
          <population>Analysis was performed on SafAS population, which included participants who received at least one dose of the study vaccines (CYD dengue or Tdap). Here, 'Number analyzed' = participants with available data for each specified category.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="338"/>
                <count group_id="O2" value="342"/>
              </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="338"/>
                    <count group_id="O2" value="342"/>
                  </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 Tdap vaccination 1 (Visit 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="342"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post CYD/Tdap vaccination (Visit 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="338"/>
                    <count group_id="O2" value="338"/>
                  </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 2 (Visit 4)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="321"/>
                    <count group_id="O2" value="319"/>
                  </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 With Solicited Injection Site Reactions Following Vaccination With Tdap or CYD Dengue Vaccine</title>
        <description>A solicited reaction (SR) was an AE observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the eCRF and considered as related to vaccination. Solicited injection site reactions included pain, erythema, and swelling. At Visit 1, participants of Group 1 received no vaccination and participants of Group 2 received only Tdap vaccination. At Visit 2, participants of Group 1 received both CYD and Tdap vaccinations and participants of Group 2 received only CYD vaccination. At Visit 4, participants of Groups 1 and 2 received only CYD vaccination.</description>
        <time_frame>Within 7 days after any and each vaccination</time_frame>
        <population>Analysis was performed on SafAS population. Here, 'Number analyzed' = participants with available data for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)</title>
            <description>Participants received 1 booster dose of Tdap vaccine 0.5 mL IM injection at Month 1, and 2 doses of CYD dengue vaccine 0.5 mL SC injection at Month 1 (concomitantly with Tdap booster dose) and at Month 7.</description>
          </group>
          <group group_id="O2">
            <title>CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)</title>
            <description>Participants received 1 booster dose of Tdap vaccine 0.5 mL IM injection at Day 0 and 2 doses of CYD dengue vaccine 0.5 mL SC injection at Month 1 (sequentially, one month after the Tdap booster dose) and at Month 7.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Solicited Injection Site Reactions Following Vaccination With Tdap or CYD Dengue Vaccine</title>
          <description>A solicited reaction (SR) was an AE observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the eCRF and considered as related to vaccination. Solicited injection site reactions included pain, erythema, and swelling. At Visit 1, participants of Group 1 received no vaccination and participants of Group 2 received only Tdap vaccination. At Visit 2, participants of Group 1 received both CYD and Tdap vaccinations and participants of Group 2 received only CYD vaccination. At Visit 4, participants of Groups 1 and 2 received only CYD vaccination.</description>
          <population>Analysis was performed on SafAS population. Here, 'Number analyzed' = participants with available data for each specified category.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="338"/>
                <count group_id="O2" value="342"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pain: Post any vaccination</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="338"/>
                    <count group_id="O2" value="341"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="229"/>
                    <measurement group_id="O2" value="237"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain: Post Tdap vaccination (Visit 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="341"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="212"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain: Post CYD/Tdap vaccination (Visit 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="338"/>
                    <count group_id="O2" value="338"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="218"/>
                    <measurement group_id="O2" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain: Post CYD vaccination 2 (Visit 4)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="320"/>
                    <count group_id="O2" value="319"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61"/>
                    <measurement group_id="O2" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema: Post any vaccination</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="338"/>
                    <count group_id="O2" value="341"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema: Post Tdap vaccination (Visit 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="341"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema: Post CYD/Tdap vaccination (Visit 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="338"/>
                    <count group_id="O2" value="338"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema: Post CYD vaccination 2 (Visit 4)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="320"/>
                    <count group_id="O2" value="319"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling: Post any vaccination</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="338"/>
                    <count group_id="O2" value="341"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling: Post Tdap vaccination (Visit 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="341"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling: Post CYD/Tdap vaccination (Visit 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="338"/>
                    <count group_id="O2" value="338"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling: Post CYD vaccination 2 (Visit 4)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="320"/>
                    <count group_id="O2" value="319"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine</title>
        <description>A SR reaction was an AE observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the CRF and considered as related to vaccination. Solicited injection site reactions included fever, headache, malaise, myalgia, and asthenia. At Visit 1, participants of Group 1 received no vaccination and participants of Group 2 received only Tdap vaccination. At Visit 2, participants of Group 1 received both CYD and Tdap vaccinations and participants of Group 2 received only CYD vaccination. At Visit 4, participants of Groups 1 and 2 received only CYD vaccination.</description>
        <time_frame>Within 14 days after any and each vaccination</time_frame>
        <population>Analysis was performed on SafAS population. Here, 'Number analyzed' = participants with available data for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)</title>
            <description>Participants received 1 booster dose of Tdap vaccine 0.5 mL IM injection at Month 1, and 2 doses of CYD dengue vaccine 0.5 mL SC injection at Month 1 (concomitantly with Tdap booster dose) and at Month 7.</description>
          </group>
          <group group_id="O2">
            <title>CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)</title>
            <description>Participants received 1 booster dose of Tdap vaccine 0.5 mL IM injection at Day 0 and 2 doses of CYD dengue vaccine 0.5 mL SC injection at Month 1 (sequentially, one month after the Tdap booster dose) and at Month 7.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine</title>
          <description>A SR reaction was an AE observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the CRF and considered as related to vaccination. Solicited injection site reactions included fever, headache, malaise, myalgia, and asthenia. At Visit 1, participants of Group 1 received no vaccination and participants of Group 2 received only Tdap vaccination. At Visit 2, participants of Group 1 received both CYD and Tdap vaccinations and participants of Group 2 received only CYD vaccination. At Visit 4, participants of Groups 1 and 2 received only CYD vaccination.</description>
          <population>Analysis was performed on SafAS population. Here, 'Number analyzed' = participants with available data for each specified category.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="338"/>
                <count group_id="O2" value="342"/>
              </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="338"/>
                    <count group_id="O2" value="340"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever: Post Tdap vaccination (Visit 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="339"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever: Post CYD/Tdap vaccination (Visit 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="338"/>
                    <count group_id="O2" value="338"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever: Post CYD vaccination 2 (Visit 4)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="320"/>
                    <count group_id="O2" value="319"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="9"/>
                  </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="338"/>
                    <count group_id="O2" value="341"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89"/>
                    <measurement group_id="O2" value="115"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache: Post Tdap vaccination (Visit 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="341"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache: Post CYD/Tdap vaccination (Visit 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="338"/>
                    <count group_id="O2" value="338"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70"/>
                    <measurement group_id="O2" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache: Post CYD vaccination 2 (Visit 4)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="320"/>
                    <count group_id="O2" value="319"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                    <measurement group_id="O2" value="35"/>
                  </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="338"/>
                    <count group_id="O2" value="341"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91"/>
                    <measurement group_id="O2" value="111"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Malaise: Post Tdap vaccination (Visit 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="341"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Malaise: Post CYD/Tdap vaccination (Visit 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="338"/>
                    <count group_id="O2" value="338"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74"/>
                    <measurement group_id="O2" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Malaise: Post CYD vaccination 2 (Visit 4)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="320"/>
                    <count group_id="O2" value="319"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="33"/>
                  </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="338"/>
                    <count group_id="O2" value="341"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74"/>
                    <measurement group_id="O2" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia: Post Tdap vaccination (Visit 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="341"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia: Post CYD/Tdap vaccination (Visit 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="338"/>
                    <count group_id="O2" value="338"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67"/>
                    <measurement group_id="O2" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia: Post CYD vaccination 2 (Visit 4)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="320"/>
                    <count group_id="O2" value="319"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="22"/>
                  </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="338"/>
                    <count group_id="O2" value="341"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67"/>
                    <measurement group_id="O2" value="94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asthenia: Post Tdap vaccination (Visit 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="341"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asthenia: Post CYD/Tdap vaccination (Visit 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="338"/>
                    <count group_id="O2" value="338"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asthenia: Post CYD vaccination 2 (Visit 4)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="320"/>
                    <count group_id="O2" value="319"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Reporting Unsolicited Adverse Events Following Vaccination With Tdap or CYD Dengue Vaccine</title>
        <description>An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF in terms of diagnosis and/or onset post-vaccination. At Visit 1, participants of Group 1 received no vaccination and participants of Group 2 received only Tdap vaccination. At Visit 2, participants of Group 1 received both CYD and Tdap vaccinations and participants of Group 2 received only CYD vaccination. At Visit 4, participants of Groups 1 and 2 received CYD vaccination.</description>
        <time_frame>Within 28 days after any and each vaccination</time_frame>
        <population>Analysis was performed on SafAS population. Here, 'Number analyzed' = participants with available data for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)</title>
            <description>Participants received 1 booster dose of Tdap vaccine 0.5 mL IM injection at Month 1, and 2 doses of CYD dengue vaccine 0.5 mL SC injection at Month 1 (concomitantly with Tdap booster dose) and at Month 7.</description>
          </group>
          <group group_id="O2">
            <title>CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)</title>
            <description>Participants received 1 booster dose of Tdap vaccine 0.5 mL IM injection at Day 0 and 2 doses of CYD dengue vaccine 0.5 mL SC injection at Month 1 (sequentially, one month after the Tdap booster dose) and at Month 7.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting Unsolicited Adverse Events Following Vaccination With Tdap or CYD Dengue Vaccine</title>
          <description>An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF in terms of diagnosis and/or onset post-vaccination. At Visit 1, participants of Group 1 received no vaccination and participants of Group 2 received only Tdap vaccination. At Visit 2, participants of Group 1 received both CYD and Tdap vaccinations and participants of Group 2 received only CYD vaccination. At Visit 4, participants of Groups 1 and 2 received CYD vaccination.</description>
          <population>Analysis was performed on SafAS population. Here, 'Number analyzed' = participants with available data for each specified category.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="338"/>
                <count group_id="O2" value="342"/>
              </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="338"/>
                    <count group_id="O2" value="342"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56"/>
                    <measurement group_id="O2" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Tdap vaccination (Visit 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="342"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post CYD/Tdap vaccination (Visit 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="338"/>
                    <count group_id="O2" value="338"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post CYD vaccination 2 (Visit 4)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="321"/>
                    <count group_id="O2" value="319"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="26"/>
                  </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 Tdap or CYD Dengue Vaccine</title>
        <description>Non-serious AESIs were non-serious AEs that were considered by the Sponsor to be relevant for the monitoring of the safety profile of the investigational vaccine. At Visit 1, participants of Group 1 received no vaccination and participants of Group 2 received only Tdap vaccination. At Visit 2, participants of Group 1 received both CYD and Tdap vaccinations and participants of Group 2 received only CYD vaccination. At Visit 4, participants of Groups 1 and 2 received CYD vaccination.</description>
        <time_frame>Within 7 days post any and each vaccination</time_frame>
        <population>Analysis was performed on SafAS population. Here, 'Number analyzed' = participants with available data for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)</title>
            <description>Participants received 1 booster dose of Tdap vaccine 0.5 mL IM injection at Month 1, and 2 doses of CYD dengue vaccine 0.5 mL SC injection at Month 1 (concomitantly with Tdap booster dose) and at Month 7.</description>
          </group>
          <group group_id="O2">
            <title>CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)</title>
            <description>Participants received 1 booster dose of Tdap vaccine 0.5 mL IM injection at Day 0 and 2 doses of CYD dengue vaccine 0.5 mL SC injection at Month 1 (sequentially, one month after the Tdap booster dose) and at Month 7.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting Non-serious Adverse Event of Special Interests (AESIs) Following Vaccination With Tdap or CYD Dengue Vaccine</title>
          <description>Non-serious AESIs were non-serious AEs that were considered by the Sponsor to be relevant for the monitoring of the safety profile of the investigational vaccine. At Visit 1, participants of Group 1 received no vaccination and participants of Group 2 received only Tdap vaccination. At Visit 2, participants of Group 1 received both CYD and Tdap vaccinations and participants of Group 2 received only CYD vaccination. At Visit 4, participants of Groups 1 and 2 received CYD vaccination.</description>
          <population>Analysis was performed on SafAS population. Here, 'Number analyzed' = participants with available data for each specified category.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="338"/>
                <count group_id="O2" value="342"/>
              </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="338"/>
                    <count group_id="O2" value="342"/>
                  </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 Tdap vaccination (Visit 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="342"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post CYD/Tdap vaccination (Visit 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="338"/>
                    <count group_id="O2" value="338"/>
                  </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 2 (Visit 4)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="321"/>
                    <count group_id="O2" value="319"/>
                  </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) and Serious AESIs Following Vaccination With Tdap or CYD Dengue Vaccine</title>
        <description>SAEs were AEs resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; required hospitalization or prolonged existing hospitalization; persistent or significant disability/incapacity; congenital anomaly or a medically important event. Serious AESIs were SAEs 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 Tdap or CYD vaccination</time_frame>
        <population>Analysis was performed on SafAS population.</population>
        <group_list>
          <group group_id="O1">
            <title>CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)</title>
            <description>Participants received 1 booster dose of Tdap vaccine 0.5 mL IM injection at Month 1, and 2 doses of CYD dengue vaccine 0.5 mL SC injection at Month 1 (concomitantly with Tdap booster dose) and at Month 7.</description>
          </group>
          <group group_id="O2">
            <title>CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)</title>
            <description>Participants received 1 booster dose of Tdap vaccine 0.5 mL IM injection at Day 0 and 2 doses of CYD dengue vaccine 0.5 mL SC injection at Month 1 (sequentially, one month after the Tdap booster dose) and at Month 7.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting Serious Adverse Events (SAEs) and Serious AESIs Following Vaccination With Tdap or CYD Dengue Vaccine</title>
          <description>SAEs were AEs resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; required hospitalization or prolonged existing hospitalization; persistent or significant disability/incapacity; congenital anomaly or a medically important event. Serious AESIs were SAEs 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 SafAS population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="338"/>
                <count group_id="O2" value="342"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serious AESI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </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 Tdap 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 Tdap or CYD vaccination</time_frame>
        <population>Analysis was performed on SafAS population.</population>
        <group_list>
          <group group_id="O1">
            <title>CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)</title>
            <description>Participants received 1 booster dose of Tdap vaccine 0.5 mL IM injection at Month 1, and 2 doses of CYD dengue vaccine 0.5 mL SC injection at Month 1 (concomitantly with Tdap booster dose) and at Month 7.</description>
          </group>
          <group group_id="O2">
            <title>CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)</title>
            <description>Participants received 1 booster dose of Tdap vaccine 0.5 mL IM injection at Day 0 and 2 doses of CYD dengue vaccine 0.5 mL SC injection at Month 1 (sequentially, one month after the Tdap booster dose) and at Month 7.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting Cases of Virologically Confirmed Dengue (VCD) Hospitalization Following Vaccination With Tdap 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 SafAS population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="338"/>
                <count group_id="O2" value="342"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                  </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. SR data were collected from Day 0 up to Day 14 post-vaccination. The SAEs were collected throughout the trial, i.e. up to 6 months after last Tdap or CYD vaccination.</time_frame>
      <desc>SR was an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.</desc>
      <group_list>
        <group group_id="E1">
          <title>CYD Dengue Vaccine + Tdap Vaccine (Concomitant Administration)</title>
          <description>Participants received 1 booster dose of Tdap vaccine 0.5 mL IM injection at Month 1, and 2 doses of CYD dengue vaccine 0.5 mL SC injection at Month 1 (concomitantly with Tdap booster dose) and at Month 7.</description>
        </group>
        <group group_id="E2">
          <title>CYD Dengue Vaccine + Tdap Vaccine (Sequential Administration)</title>
          <description>Participants received 1 booster dose of Tdap vaccine 0.5 mL IM injection at Day 0 and 2 doses of CYD dengue vaccine 0.5 mL SC injection at Month 1 (sequentially, one month after the Tdap booster dose) and at Month 7.</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="338"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="342"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="338"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="342"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertensive Heart Disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="338"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="342"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="338"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="342"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="338"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="342"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Jaundice Cholestatic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="338"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="342"/>
              </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="338"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="342"/>
              </event>
              <event>
                <sub_title>Atypical Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="338"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="342"/>
              </event>
              <event>
                <sub_title>Dengue Fever</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="338"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="342"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="338"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="342"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Incisional Hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="338"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="342"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Breast Cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="338"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="342"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebral Infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="338"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="342"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="338"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="342"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Abortion Complete</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="338"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="342"/>
              </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="338"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="342"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash Generalised</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="338"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="342"/>
              </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="248" subjects_at_risk="338"/>
                <counts group_id="E2" subjects_affected="263" subjects_at_risk="342"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="78" subjects_affected="67" subjects_at_risk="338"/>
                <counts group_id="E2" events="115" subjects_affected="94" subjects_at_risk="342"/>
              </event>
              <event>
                <sub_title>Injection Site Pain</sub_title>
                <counts group_id="E1" events="376" subjects_affected="229" subjects_at_risk="338"/>
                <counts group_id="E2" events="320" subjects_affected="237" subjects_at_risk="342"/>
              </event>
              <event>
                <sub_title>Injection Site Swelling</sub_title>
                <counts group_id="E1" events="29" subjects_affected="25" subjects_at_risk="338"/>
                <counts group_id="E2" events="35" subjects_affected="32" subjects_at_risk="342"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="106" subjects_affected="91" subjects_at_risk="338"/>
                <counts group_id="E2" events="142" subjects_affected="111" subjects_at_risk="342"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <description>Pyrexia/fever events that occurred after 14 days post-vaccination were considered as unsolicited AEs.</description>
                <counts group_id="E1" events="22" subjects_affected="22" subjects_at_risk="338"/>
                <counts group_id="E2" events="33" subjects_affected="32" subjects_at_risk="342"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" events="17" subjects_affected="17" subjects_at_risk="338"/>
                <counts group_id="E2" events="21" subjects_affected="17" subjects_at_risk="342"/>
              </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="93" subjects_affected="74" subjects_at_risk="338"/>
                <counts group_id="E2" events="130" subjects_affected="100" subjects_at_risk="342"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <description>Headache event that occurred after 14 days post-vaccination was considered as an unsolicited AE.</description>
                <counts group_id="E1" events="106" subjects_affected="89" subjects_at_risk="338"/>
                <counts group_id="E2" events="152" subjects_affected="116" subjects_at_risk="342"/>
              </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>Due to absence of response of competent authorities from The Philippines on protocol amendment, the study was prematurely terminated before injection of last dose (3rd dose) of the CYD dengue vaccine. Objectives related to 3rd dose were not assessed.</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/NCT02992418
org study id: CYD66
secondary id: U1111-1161-3294
secondary id: 2019-003136-23
nct id: NCT02992418
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The aim of the study was to investigate the immunogenicity and safety of CYD dengue vaccine
      and Tetanus Toxoid (T), Reduced Diphtheria Toxoid (D) and Acellular Pertussis Vaccine
      Adsorbed (ap) (Tdap) vaccine when both vaccines were administered concomitantly or
      sequentially.

      Primary Objectives:

        -  To demonstrate the non-inferiority of the humoral immune response to the Tdap booster
           dose concomitantly administered with the first dose of CYD dengue vaccine as compared to
           sequential administration, measured 28 days after Tdap booster dose.

        -  To demonstrate the non-inferiority of the humoral immune response to the first dose of
           CYD dengue vaccine concomitantly administered with Tdap as compared to sequential
           administration, measured 28 days after the first dose of CYD dengue vaccine.

      Secondary Objectives:

        -  To demonstrate the non-inferiority of the humoral immune response of 3 doses of CYD
           dengue vaccine with the first dose concomitantly administered with Tdap as compared to
           sequential administration, measured 28 days after the third dose of CYD dengue vaccine.

        -  To describe the humoral immune response at baseline and 28 days after the first and
           third doses of CYD dengue vaccine, in each and any group.

        -  To describe the humoral immune response of Tdap vaccine at baseline and 28 days after
           concomitant administration with the first dose of CYD dengue vaccine as compared to the
           sequential administration, in each and any group.

        -  To describe the safety of the CYD dengue vaccine and of the Tdap booster dose after each
           and any injection in each group.
Participants were to receive CYD dengue vaccine according to a 3-dose schedule administered 6
      months apart, with the first dose of CYD dengue vaccine administered either concomitantly or
      sequentially with a booster dose of the Tdap vaccine, Adacel®.

      During the conduct of the study, a safety signal was identified which led to the Independent
      Data Monitoring Committee (IDMC) recommendation not to vaccinate participants who had never
      been infected by dengue prior to the first injection, i.e., dengue non-immune participants.
      The protocol was amended accordingly but never implemented due to absence of response of
      Health Authorities (HA) from The Philippines.

      After having waited for more than 1.5 years, and as the participants became out of window to
      complete their immunization schedule and the last safety follow-up call (6 months after the
      last dose), the Sponsor decided to stop the trial. Participants only attended a last safety
      follow-up visit to terminate the study and were informed about the end of the study. As a
      consequence, the study was prematurely terminated before injection of the last dose (3rd
      dose) of the CYD dengue vaccine.

      As a consequence of the IDMC recommendations, the main immunogenicity analyses were done in
      dengue immune participants which is not what was planned in the protocol (and this is why the
      primary endpoints are not exactly the same as those defined in the protocol as they were
      finally assessed only in dengue immune participants whereas initially it was planned to be
      assessed regardless of baseline status).

      All participants were assessed for immunogenicity and safety. 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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Geometric Mean Concentrations (GMCs) of Antibodies Against Pertussis Antigens (Pertussis Toxoid, Filamentous Hemagglutinin, Pertactin, and Fimbriae 2+3) 28 Days After Dose of Tdap Vaccine in Previously Dengue Immune Participants
time frame: 28 days after Tdap vaccination
description: GMCs against each pertussis antigens (pertussis toxoid [PT], filamentous hemagglutinin [FHA], pertactin [PRN], fimbriae types 2 and 3 [FIM2+3]) were assessed using an enzyme-linked immunosorbent assay (ELISA) method and were measured in ELISA unit/milliliter (EU/mL). Dengue immune participants at Baseline were defined as participants with titers >=10 (1/dilution) for at least one serotype with the parental dengue virus strain.
measure: Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens 28 Days After the Dose of Tdap Vaccine in the Previously Dengue Immune Participants
time frame: 28 days after Tdap vaccination
description: Seroprotection against diphtheria (Anti-D) and tetanus (Anti-T) antigens was performed by Micrometabolic Inhibition Test - Toxin Neutralization assay (MIT-TNA) and ELISA, respectively. Seroprotection was defined as anti-D and anti-T Ab concentration greater than 0.1 international units (IU)/mL. Dengue immune participants at Baseline were defined as participants with titers >=10 (1/dilution) for at least one serotype with the parental dengue virus strain.
measure: Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants
time frame: 28 days after first CYD dengue vaccination
description: The GMTs against each of the four parenteral dengue virus serotypes (1, 2, 3 and 4) of CYD dengue vaccine were assessed using the 50% plaque reduction neutralization test (PRNT50) assay method. Dengue immune participants at Baseline were defined as participants with titers >=10 (1/dilution) for at least one serotype with the parental dengue virus strain. Titers were measured in terms of 1/dilution.
measure: Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants
time frame: Baseline (Pre-CYD vaccination 1) and 28 days after the first CYD dengue vaccination
description: The GMTs against each of the four parenteral dengue virus serotypes (1, 2, 3 and 4) of CYD dengue vaccine were assessed using PRNT50 assay method. Dengue immune participants at Baseline were defined as participants with titers >=10 (1/dilution) for at least one serotype with the parental dengue virus strain. Titers were measured in terms of 1/dilution.
measure: Percentage of Participants With Neutralizing Antibody Titers Against Each of the 4 Dengue Virus Serotypes of CYD at Baseline and 28 Days After First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants
time frame: Baseline (Pre-CYD vaccination 1) and 28 days after the first CYD dengue vaccination
description: The GMTs against each of the four parenteral dengue virus serotypes (1, 2, 3 and 4) of CYD dengue vaccine were assessed using PRNT50 assay method. Dengue immune participants at Baseline were defined as participants with titers >=10 (1/dilution) for at least one serotype with the parental dengue virus strain.
measure: Percentage of Participants With Neutralizing Antibody Titers Above Predefined Thresholds Against at Least 1, 2, 3, or 4 Serotypes of CYD at Baseline and 28 Days After the First Dose of CYD Dengue Vaccination in the Previously Dengue Immune Participants
time frame: Baseline (Pre-CYD vaccination 1) and 28 days after the first CYD dengue vaccination
description: Dengue neutralizing antibody levels against each of the 4 dengue virus serotypes (1, 2, 3, and 4) were measured by PRNT50. Dengue immune participants at Baseline were defined as participants with titers >=10 (1/dilution) for at least one serotype with the parental dengue virus strain. Percentage of participants with neutralizing antibody titers above pre-defined thresholds (>=10 and >=100 [1/dilution]) against at least 1, 2, 3, or 4 serotypes of CYD were reported. Here, 'dil'=dilution and "vac"=vaccination in the specified categories.
measure: Geometric Mean Concentrations of Serum Antibodies Against Pertussis Antigens (Pertussis Toxoid, Filamentous Hemagglutinin, Pertactin, and Fimbriae 2+3) at Baseline and 28 Days After the Dose of Tdap Vaccine in the Previously Dengue Immune Participants
time frame: Baseline (Pre-Tdap vaccination) and 28 days after the Tdap vaccination
description: GMCs against each pertussis antigens (PT, FHA, PRN, FIM2+3) were assessed using ELISA assay method and were measured in EU/mL. Dengue immune participants at Baseline were defined as participants with titers >=10 (1/dilution) for at least one serotype with the parental dengue virus strain.
measure: Percentage of Participants Achieving Serum Antibody (>=0.1 IU/mL) Against Diphtheria and Tetanus Antigens at Baseline and 28 Days After the Dose of Tdap Vaccine in the Previously Dengue Immune Participants
time frame: Baseline (Pre-Tdap vaccination) and 28 days after the dose of Tdap vaccination
description: The GMC against diphtheria and tetanus antigens was performed by MIT-TNA and ELISA, respectively. Dengue immune participants at Baseline were defined as participants with titers >=10 (1/dilution) for at least one serotype with the parental dengue virus strain.
measure: Number of Participants With Immediate Unsolicited Adverse Events (AE) Following Vaccination With Tdap or CYD Dengue Vaccine
time frame: Within 30 minutes after any and each vaccination
description: An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the electronic case report form (eCRF) in terms of diagnosis and/or onset post-vaccination. Any unsolicited AE occurred during first 30 minutes post-vaccination was recorded on the CRF as immediate AE. At Visit 1, participants of Group 1 received no vaccination and participants of Group 2 received only Tdap vaccination. At Visit 2, participants of Group 1 received both CYD and Tdap vaccination and participants of Group 2 received only CYD vaccination. At Visit 4, participants of Groups 1 and 2 received CYD vaccination.
measure: Number of Participants With Solicited Injection Site Reactions Following Vaccination With Tdap or CYD Dengue Vaccine
time frame: Within 7 days after any and each vaccination
description: A solicited reaction (SR) was an AE observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the eCRF and considered as related to vaccination. Solicited injection site reactions included pain, erythema, and swelling. At Visit 1, participants of Group 1 received no vaccination and participants of Group 2 received only Tdap vaccination. At Visit 2, participants of Group 1 received both CYD and Tdap vaccinations and participants of Group 2 received only CYD vaccination. At Visit 4, participants of Groups 1 and 2 received only CYD vaccination.
measure: Number of Participants With Solicited Systemic Reactions Following Vaccination With Tdap or CYD Dengue Vaccine
time frame: Within 14 days after any and each vaccination
description: A SR reaction was an AE observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the CRF and considered as related to vaccination. Solicited injection site reactions included fever, headache, malaise, myalgia, and asthenia. At Visit 1, participants of Group 1 received no vaccination and participants of Group 2 received only Tdap vaccination. At Visit 2, participants of Group 1 received both CYD and Tdap vaccinations and participants of Group 2 received only CYD vaccination. At Visit 4, participants of Groups 1 and 2 received only CYD vaccination.
measure: Number of Participants Reporting Unsolicited Adverse Events Following Vaccination With Tdap or CYD Dengue Vaccine
time frame: Within 28 days after any and each vaccination
description: An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF in terms of diagnosis and/or onset post-vaccination. At Visit 1, participants of Group 1 received no vaccination and participants of Group 2 received only Tdap vaccination. At Visit 2, participants of Group 1 received both CYD and Tdap vaccinations and participants of Group 2 received only CYD vaccination. At Visit 4, participants of Groups 1 and 2 received CYD vaccination.
measure: Number of Participants Reporting Non-serious Adverse Event of Special Interests (AESIs) Following Vaccination With Tdap or CYD Dengue Vaccine
time frame: Within 7 days post any and each vaccination
description: Non-serious AESIs were non-serious AEs that were considered by the Sponsor to be relevant for the monitoring of the safety profile of the investigational vaccine. At Visit 1, participants of Group 1 received no vaccination and participants of Group 2 received only Tdap vaccination. At Visit 2, participants of Group 1 received both CYD and Tdap vaccinations and participants of Group 2 received only CYD vaccination. At Visit 4, participants of Groups 1 and 2 received CYD vaccination.
measure: Number of Participants Reporting Serious Adverse Events (SAEs) and Serious AESIs Following Vaccination With Tdap or CYD Dengue Vaccine
time frame: From Day 0 up to 6 months after the last Tdap or CYD vaccination
description: SAEs were AEs resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; required hospitalization or prolonged existing hospitalization; persistent or significant disability/incapacity; congenital anomaly or a medically important event. Serious AESIs were SAEs 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 Tdap or CYD Dengue Vaccine
time frame: From Day 0 up to 6 months after the last Tdap or CYD 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: Concomitant Administration Group
arm group type: Experimental
description: Participants will be administered the first dose of CYD dengue vaccine concomitantly with a dose of Tdap vaccine.
arm group label: Sequential Administration Group
arm group type: Experimental
description: Participants will be administered the first dose of CYD dengue vaccine 28 days after a dose of Tdap vaccine.
intervention type: Biological
intervention name: CYD Dengue Vaccine
description: 0.5 milliliter (mL), Subcutaneous at Month 1, 7 and Month 13, respectively
arm group label: Concomitant Administration Group
arm group label: Sequential Administration Group
other name: Dengvaxia®
intervention type: Biological
intervention name: Tdap: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine adsorbed
description: 0.5 mL, intramuscularly (IM) at Month 1.
arm group label: Concomitant Administration Group
other name: Adacel®
intervention type: Biological
intervention name: Tdap: Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed
description: 0.5 mL, intramuscularly at Day 0.
arm group label: Sequential Administration Group
other name: Adacel®
criteria: 
gender: All
minimum age: 9 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Medical Director
role: Study Director
affiliation: Sanofi Pasteur SA
facility: 
facility: 
facility: 
facility: 
country: Philippines
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: Due to absence of response of competent authorities from The Philippines on protocol amendment, the study was prematurely terminated before injection of last dose (3rd dose) of the CYD dengue vaccine. Objectives related to 3rd dose were not assessed.
point of contact: 