<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/NCT02258178</url>
  </required_header>
  <id_info>
    <org_study_id>V58_36OB</org_study_id>
    <nct_id>NCT02258178</nct_id>
  </id_info>
  <brief_title>Flucelvax Pregnancy Registry</brief_title>
  <official_title>Flucelvax Pregnancy Registry: an Observational Study on the Safety of Flucelvax Exposure in Pregnant Women and Their Offspring</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seqirus</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seqirus</source>
  <brief_summary>
    <textblock>
      The goal of the registry is to develop a better understanding of the safety of Flucelvax in&#xD;
      women and their offspring who were exposed to the vaccine during pregnancy&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">June 2020</completion_date>
  <primary_completion_date type="Anticipated">June 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>major congenital malformation</measure>
    <time_frame>From time of enrollment during pregnancy to time of delivery or pregnancy termination</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>preterm birth</measure>
    <time_frame>From time of enrollment during pregnancy to time of delivery or pregnancy termination</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>low birth weight</measure>
    <time_frame>From time of enrollment during pregnancy to time of delivery or pregnancy termination</time_frame>
  </primary_outcome>
  <other_outcome>
    <measure>Live birth</measure>
    <time_frame>From time of enrollment during pregnancy to time of delivery or pregnancy termination</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>stillbirth</measure>
    <time_frame>From time of enrollment during pregnancy to time of delivery or pregnancy termination</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>spontaneous abortion</measure>
    <time_frame>From time of enrollment during pregnancy to time of delivery or pregnancy termination</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>ectopic pregnancy</measure>
    <time_frame>From time of enrollment during pregnancy to time of delivery or pregnancy termination</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>molar pregnancy</measure>
    <time_frame>From time of enrollment during pregnancy to time of delivery or pregnancy termination</time_frame>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Pregnant Women, Influenza</condition>
  <arm_group>
    <arm_group_label>1, Flucelvax</arm_group_label>
    <description>Flucelvax exposure in pregnancy</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Flucelvax (cTIV)</intervention_name>
    <description>vaccine exposure in routine care (no vaccination per protocol)</description>
    <arm_group_label>1, Flucelvax</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women aged 18 years or older within the US who were immunized with the Flucelvax&#xD;
        vaccine at any time during pregnancy.The registry will allow eligible pregnant women to&#xD;
        selfenroll and also allow HCPs to report de-identified data on pregnancy exposures and&#xD;
        outcomes&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnancy women pregnant women aged 18 years or older within the US who were immunized&#xD;
             with the Flucelvax vaccine at any time during pregnancy.The registry will allow&#xD;
             eligible pregnant women to selfenroll and also allow HCPs to report de-identified data&#xD;
             on pregnancy exposures and outcomes.&#xD;
&#xD;
          -  Sufficient evidence to confirm that Flucelvax exposure occurred during pregnancy&#xD;
&#xD;
          -  Sufficient information to determine whether the pregnancy is prospectively or&#xD;
             retrospectively registered (ie, whether the outcome of pregnancy was known at the time&#xD;
             of first contact with the registry)&#xD;
&#xD;
          -  Date the pregnancy exposure is registered&#xD;
&#xD;
          -  Full reporter (ie, HCP) contact information to allow for follow-up (name, address,etc)&#xD;
             The primary population for analysis will include prospectively enrolled pregnancies&#xD;
             exposed to Flucelvax that are not lost to follow-up (ie, with outcome information that&#xD;
             meet the minimum criteria for evaluation)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Invalid registry reports and pregnancies deemed lost to follow-up will be excluded&#xD;
             from the primary analysis. Retrospective reports will not be included, although&#xD;
             retrospective cases with MCMs will be reviewed and reported separately.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>PPD</name>
      <address>
        <city>Wilmington</city>
        <state>North Carolina</state>
        <zip>28401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 7, 2014</study_first_posted>
  <last_update_submitted>October 3, 2017</last_update_submitted>
  <last_update_submitted_qc>October 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02258178
org study id: V58_36OB
nct id: NCT02258178
lead sponsor: 
The goal of the registry is to develop a better understanding of the safety of Flucelvax in
      women and their offspring who were exposed to the vaccine during pregnancy
observational model: Cohort
time perspective: Other
measure: major congenital malformation
time frame: From time of enrollment during pregnancy to time of delivery or pregnancy termination
measure: preterm birth
time frame: From time of enrollment during pregnancy to time of delivery or pregnancy termination
measure: low birth weight
time frame: From time of enrollment during pregnancy to time of delivery or pregnancy termination
measure: Live birth
time frame: From time of enrollment during pregnancy to time of delivery or pregnancy termination
measure: stillbirth
time frame: From time of enrollment during pregnancy to time of delivery or pregnancy termination
measure: spontaneous abortion
time frame: From time of enrollment during pregnancy to time of delivery or pregnancy termination
measure: ectopic pregnancy
time frame: From time of enrollment during pregnancy to time of delivery or pregnancy termination
measure: molar pregnancy
time frame: From time of enrollment during pregnancy to time of delivery or pregnancy termination
arm group label: 1, Flucelvax
description: Flucelvax exposure in pregnancy
intervention type: Biological
intervention name: Flucelvax (cTIV)
description: vaccine exposure in routine care (no vaccination per protocol)
arm group label: 1, Flucelvax
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor