<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/NCT03803618</url>
  </required_header>
  <id_info>
    <org_study_id>UPM REB 2017-0237</org_study_id>
    <nct_id>NCT03803618</nct_id>
  </id_info>
  <brief_title>Dengue Effectiveness Study in the Philippines</brief_title>
  <official_title>Effectiveness of the Tetravalent Dengue Vaccine, CYD-TDV (Dengvaxia®) in the Philippines</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of the Philippines</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sanofi Pasteur, a Sanofi Company</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Research Institute for Tropical Medicine, Philippines</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of the Philippines</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an observational study that aims to determine the effectiveness of a tetravalent&#xD;
      dengue vaccine (CYD-TDV) when given through a community-based immunization program against&#xD;
      hospitalized and /or severe virologically confirmed dengue.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a matched case-control study. Cases will be children who are admitted with a clinical&#xD;
      suspicion of dengue at the study hospitals and were eligible to have received the dengue&#xD;
      vaccine during the mass immunization. The outcome of interest is hospitalized and/or severe&#xD;
      virologically-confirmed dengue and the exposure is receipt of the dengue vaccine. Each case&#xD;
      will be matched to two controls who were also eligible to have received the dengue vaccine&#xD;
      and lives in the same area as the case. Cases and controls will be matched by age and sex.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">April 30, 2023</completion_date>
  <primary_completion_date type="Actual">November 30, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>hospitalized and / or severe virologically confirmed dengue</measure>
    <time_frame>5 years</time_frame>
    <description>The primary outcome are children who are hospitalized and/or severe virologically confirmed dengue</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">2081</enrollment>
  <condition>Dengue</condition>
  <condition>Severe Dengue</condition>
  <condition>Virologically Confirmed Dengue</condition>
  <arm_group>
    <arm_group_label>Confirmed dengue case</arm_group_label>
    <description>Dengue cases who are 9-14 years old during the dengue mass vaccination program in Cebu with &lt;5 days history of fever, admitted in the participating hospitals with dengue virus confirmation by RT-PCR</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Age and sex matched neighborhood controls</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Any leftover sera will be used for future studies and stored at UPM-NIH for fifteen (15)&#xD;
      years after the end of this study. Future studies using the sera will undergo appropriate&#xD;
      ethical reviews as required. After this period, specimens will be destroyed according to&#xD;
      local guidelines. Additional consent will be obtained from the parent for storage and future&#xD;
      use of these samples. Only the Principal Investigator and designated study personnel will&#xD;
      have access to these specimens.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Individuals to be enrolled in the study as probable cases will be admitted patients in the&#xD;
        hospital study sites who are residents of the area, eligible to have received the dengue&#xD;
        vaccine at the time of the initiation of community-based dengue vaccination program, and&#xD;
        suspected to have dengue.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        CASE-CONTROL STUDIES&#xD;
&#xD;
          -  For a suspected case to be enrolled in the study, he/she should:&#xD;
&#xD;
               -  Provide signed informed consent and assent (as applicable)&#xD;
&#xD;
               -  Be within the age group eligible to receive the dengue vaccine at the time of&#xD;
                  mass vaccination (i.e. no condition that would have made him/her ineligible for&#xD;
                  dengue vaccination)&#xD;
&#xD;
               -  Be admitted in any of the participating hospitals for suspected dengue&#xD;
&#xD;
               -  Have ≤5 days history of fever.&#xD;
&#xD;
               -  For the case to be included in the analysis, the participant must meet all the&#xD;
                  inclusion criteria above plus have virologically-confirmed dengue infection by&#xD;
                  RT-PCR&#xD;
&#xD;
          -  For controls to be recruited into the study, he/she should:&#xD;
&#xD;
               -  Provide signed informed consent and assent (as applicable)&#xD;
&#xD;
               -  Be age and sex-matched to the case&#xD;
&#xD;
               -  Be from the same community as the matched case&#xD;
&#xD;
               -  Be eligible to have received dengue vaccine during the community-based dengue&#xD;
                  immunization campaign in 2017 (i.e. no condition that would have made him/her&#xD;
                  ineligible for dengue vaccination)&#xD;
&#xD;
               -  Have had no episode of clinically-diagnosed or laboratory-confirmed dengue fever&#xD;
                  from the start of the community -based dengue immunization campaign to the focal&#xD;
                  time (the date of onset of dengue fever in the matched case)&#xD;
&#xD;
               -  Should not have been previously recruited as a control.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Any subject whose parent/guardian refuse to provide informed consent and/or assent.&#xD;
&#xD;
          -  In addition, the following conditions automatically exclude children from the dengue&#xD;
             mass immunization:&#xD;
&#xD;
               -  Children &lt;9 years or adults older than 45 years of age&#xD;
&#xD;
               -  Anyone who is allergic or has had an allergic reaction to a prior dose or to any&#xD;
                  component of the dengue vaccine&#xD;
&#xD;
               -  Recipient of blood product in the last 3 months&#xD;
&#xD;
               -  Immunocompromised individuals, due to but not limited to genetic defects, HIV&#xD;
                  infection, or therapies that affect the immune system such as high-dose&#xD;
                  corticosteroids or chemotherapy&#xD;
&#xD;
               -  Recipient of any vaccine within the past month&#xD;
&#xD;
               -  History of bleeding disorder&#xD;
&#xD;
               -  Pregnant or breastfeeding women&#xD;
&#xD;
               -  Enrolled in dengue vaccine Phase 3 clinical study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jacqueline L. Deen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UPM - NIH, Institute of Child Health and Human Development</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cebu Provincial Hospital - Balamban</name>
      <address>
        <city>Balamban</city>
        <state>Cebu</state>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cebu Provincial Hospital - Bogo</name>
      <address>
        <city>Bogo City</city>
        <state>Cebu</state>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cebu Provincial Hospital - Danao</name>
      <address>
        <city>Danao</city>
        <state>Cebu</state>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eversley Childs Sanitarium and General Hospital</name>
      <address>
        <city>Mandaue City</city>
        <state>Cebu</state>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Philippines</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>May 16, 2023</last_update_submitted>
  <last_update_submitted_qc>May 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dengue</mesh_term>
    <mesh_term>Severe Dengue</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03803618
org study id: UPM REB 2017-0237
nct id: NCT03803618
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
This is an observational study that aims to determine the effectiveness of a tetravalent
      dengue vaccine (CYD-TDV) when given through a community-based immunization program against
      hospitalized and /or severe virologically confirmed dengue.
This is a matched case-control study. Cases will be children who are admitted with a clinical
      suspicion of dengue at the study hospitals and were eligible to have received the dengue
      vaccine during the mass immunization. The outcome of interest is hospitalized and/or severe
      virologically-confirmed dengue and the exposure is receipt of the dengue vaccine. Each case
      will be matched to two controls who were also eligible to have received the dengue vaccine
      and lives in the same area as the case. Cases and controls will be matched by age and sex.
observational model: Case-Control
time perspective: Prospective
measure: hospitalized and / or severe virologically confirmed dengue
time frame: 5 years
description: The primary outcome are children who are hospitalized and/or severe virologically confirmed dengue
arm group label: Confirmed dengue case
description: Dengue cases who are 9-14 years old during the dengue mass vaccination program in Cebu with <5 days history of fever, admitted in the participating hospitals with dengue virus confirmation by RT-PCR
arm group label: Control
description: Age and sex matched neighborhood controls
Any leftover sera will be used for future studies and stored at UPM-NIH for fifteen (15)
      years after the end of this study. Future studies using the sera will undergo appropriate
      ethical reviews as required. After this period, specimens will be destroyed according to
      local guidelines. Additional consent will be obtained from the parent for storage and future
      use of these samples. Only the Principal Investigator and designated study personnel will
      have access to these specimens.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 9 Years
maximum age: 14 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jacqueline L. Deen, MD
role: Principal Investigator
affiliation: UPM - NIH, Institute of Child Health and Human Development
facility: 
facility: 
facility: 
facility: 
country: Philippines
responsible party type: Sponsor
mesh term: Dengue
mesh term: Severe Dengue