<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/NCT04486638</url>
  </required_header>
  <id_info>
    <org_study_id>DNG00044</org_study_id>
    <nct_id>NCT04486638</nct_id>
  </id_info>
  <brief_title>Dengvaxia US Pregnancy Registry</brief_title>
  <acronym>DNG00044</acronym>
  <official_title>Dengvaxia US Pregnancy Registry: A Surveillance Study to Assess the Safety of Dengvaxia Among Exposed Pregnant Women and Their Offsprings (DNG00044)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sanofi Pasteur, a Sanofi Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sanofi</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to assess maternal, obstetrical, pregnancy, and&#xD;
      neonatal and infant outcomes among women and their offspring(s) vaccinated with Dengvaxia&#xD;
      during their pregnancy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Exposed pregnant women will be followed up to the end of their pregnancy, and the&#xD;
      offspring(s) will be followed up to 1 year of age.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 7, 2022</start_date>
  <completion_date type="Anticipated">November 2026</completion_date>
  <primary_completion_date type="Anticipated">November 2026</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>22 Months</target_duration>
  <primary_outcome>
    <measure>Percentage of pregnant women with maternal adverse events</measure>
    <time_frame>From vaccination until end of follow-up (maximum 22 months after cohort entry)</time_frame>
    <description>Maternal adverse events are reported as serious or non-serious</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pecentage of women with obstetrical adverse events</measure>
    <time_frame>From vaccination until 1 month post-delivery</time_frame>
    <description>Obstetrical adverse events are collected during pregnancy, labour, delivery and puerperium, and are reported as serious or non-serious</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of participants with adverse pregnancy outcome</measure>
    <time_frame>On day of birth</time_frame>
    <description>Adverse pregnancy outcomes include ectopic pregnancy, elective/induced abortion with no fetal defect(s) or fetus status unknown, elective/induced abortion with fetal defect(s), spontaneous abortion/miscarriage (&lt;20 weeks), stillbirth/fetal death at 20-27 weeks, fetal death at ≥28 weeks, and fetal death due to maternal death</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of offsprings with neonatal adverse events</measure>
    <time_frame>From day of birth to 28 days post-birth</time_frame>
    <description>Neonatal events are reported as serious or non-serious</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of offsprings with infant adverse events</measure>
    <time_frame>From 29 days to 365 days post-birth</time_frame>
    <description>Infant events are reported as serious or non-serious</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Dengue Virus Infection</condition>
  <arm_group>
    <arm_group_label>Pregnant women and their offspring(s)</arm_group_label>
    <description>Women and their offspring(s) exposed to Dengvaxia during pregnancy</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Dengue Tetravalent Vaccine, Live</intervention_name>
    <description>Pharmaceutical form: Powder and solvent for suspension for injection Route of administration: Subcutaneous</description>
    <arm_group_label>Pregnant women and their offspring(s)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women of any age and their offspring(s) residing in the US and its Territories&#xD;
        whose Dengvaxia pregnancy exposure is reported to the pregnancy registry&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        The eligible population will include pregnant women of any age and their offspring(s)&#xD;
        residing in the US and its Territories whose Dengvaxia pregnancy exposure is reported to&#xD;
        the pregnancy registry.&#xD;
&#xD;
        Reports of Dengvaxia pregnancy exposure must contain the following information to be&#xD;
        included in the registry:&#xD;
&#xD;
          -  Sufficient evidence to confirm the case qualifies as &quot;exposed during pregnancy&quot;;&#xD;
&#xD;
          -  Vaccine name (brand or generic) is provided (i.e., including manufacturer unknown&#xD;
             exposures).&#xD;
&#xD;
        The above information is not intended to contain all considerations relevant to a patient's&#xD;
        potential participation in a clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Sciences &amp; Operations</last_name>
    <role>Study Director</role>
    <affiliation>Sanofi</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dengvaxia US Pregnancy Registry HelpLine</last_name>
    <phone>1-800-822-2463</phone>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Trial Transparency email recommended (Toll free number for US &amp; Canada)</last_name>
    <phone>800-633-1610</phone>
    <phone_ext>option 6</phone_ext>
    <email>Contact-Us@sanofi.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Investigational Site</name>
      <address>
        <city>Puerto Rico</city>
        <country>Puerto Rico</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Puerto Rico</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>August 17, 2023</last_update_submitted>
  <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
  <!-- 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/NCT04486638
org study id: DNG00044
nct id: NCT04486638
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The primary objective of this study is to assess maternal, obstetrical, pregnancy, and
      neonatal and infant outcomes among women and their offspring(s) vaccinated with Dengvaxia
      during their pregnancy
Exposed pregnant women will be followed up to the end of their pregnancy, and the
      offspring(s) will be followed up to 1 year of age.
observational model: Cohort
time perspective: Prospective
measure: Percentage of pregnant women with maternal adverse events
time frame: From vaccination until end of follow-up (maximum 22 months after cohort entry)
description: Maternal adverse events are reported as serious or non-serious
measure: Pecentage of women with obstetrical adverse events
time frame: From vaccination until 1 month post-delivery
description: Obstetrical adverse events are collected during pregnancy, labour, delivery and puerperium, and are reported as serious or non-serious
measure: Percentage of participants with adverse pregnancy outcome
time frame: On day of birth
description: Adverse pregnancy outcomes include ectopic pregnancy, elective/induced abortion with no fetal defect(s) or fetus status unknown, elective/induced abortion with fetal defect(s), spontaneous abortion/miscarriage (<20 weeks), stillbirth/fetal death at 20-27 weeks, fetal death at ≥28 weeks, and fetal death due to maternal death
measure: Percentage of offsprings with neonatal adverse events
time frame: From day of birth to 28 days post-birth
description: Neonatal events are reported as serious or non-serious
measure: Percentage of offsprings with infant adverse events
time frame: From 29 days to 365 days post-birth
description: Infant events are reported as serious or non-serious
arm group label: Pregnant women and their offspring(s)
description: Women and their offspring(s) exposed to Dengvaxia during pregnancy
intervention type: Biological
intervention name: Dengue Tetravalent Vaccine, Live
description: Pharmaceutical form: Powder and solvent for suspension for injection Route of administration: Subcutaneous
arm group label: Pregnant women and their offspring(s)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Clinical Sciences & Operations
role: Study Director
affiliation: Sanofi
last name: Dengvaxia US Pregnancy Registry HelpLine
phone: 1-800-822-2463
last name: Trial Transparency email recommended (Toll free number for US & Canada)
phone: 800-633-1610
phone ext: option 6
email: Contact-Us@sanofi.com
facility: 
status: Recruiting
country: Puerto Rico
responsible party type: Sponsor
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