<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/NCT04460781</url>
  </required_header>
  <id_info>
    <org_study_id>VAP00007</org_study_id>
    <nct_id>NCT04460781</nct_id>
  </id_info>
  <brief_title>Surveillance Study to Assess the Safety of Flublok Quadrivalent (Influenza Vaccine) in Pregnant Women and Their Offspring</brief_title>
  <acronym>VAP00007</acronym>
  <official_title>Post-Licensure Database Surveillance Study to Assess the Safety of Flublok Quadrivalent (Influenza Vaccine) in Pregnant Women and Their Offspring</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>
      Primary Objective:&#xD;
&#xD;
      To evaluate the safety of Flublok Quadrivalent influenza vaccine in pregnant women included&#xD;
      in the VAP00003 Study (NCT03694392) and their offspring exposed during pregnancy or up to 28&#xD;
      days preceding the estimated date of conception with regards to pregnancy, birth, and&#xD;
      neonatal/infant outcomes&#xD;
&#xD;
      Secondary Objective:&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Data will be recorded prospectively during the safety follow-up for pregnant women until&#xD;
      delivery (or pregnancy outcome, whichever is later), and for infants of pregnant women for 1&#xD;
      year after birth.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 17, 2018</start_date>
  <completion_date type="Actual">February 28, 2022</completion_date>
  <primary_completion_date type="Actual">February 28, 2022</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>1 Year</target_duration>
  <primary_outcome>
    <measure>Incidence Rates of Pregnancy Outcome Events</measure>
    <time_frame>From start of pregnancy or up to 28 days prior to conception until delivery or pregnancy outcome</time_frame>
    <description>Pregnancy outcome events: spontaneous abortion, preterm labor, stillbirth/Fetal death, congenital/fetal anomalies detected during pregnancy, eclampsia, and placental abruption</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence Rates of Birth Events</measure>
    <time_frame>At birth</time_frame>
    <description>Preterm birth, low birth weight or small for gestational age observed or diagnosed at birth</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence Rates of Neonatal/ Infant Outcomes</measure>
    <time_frame>From birth to Day 365 post-birth</time_frame>
    <description>Neonatal/ infant outcomes: infant death, any congenital anomalies detected after delivery, and failure to thrive</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">96175</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>1</arm_group_label>
    <description>Pregnant women from the VAP00003 Study and their offspring - Pregnant women from the VAP00003 Study (NCT03694392) between September 2018 and May 2020 (2 influenza seasons), and infants born from this cohort of pregnant women</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Flublok Quadrivalent influenza vaccine RIV4</intervention_name>
    <description>Route of administration: Intramuscular</description>
    <arm_group_label>1</arm_group_label>
    <other_name>RIV4</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Standard-dose quadrivalent inactivated influenza vaccine SD-IIV4</intervention_name>
    <description>Route of administration: Intramuscular</description>
    <arm_group_label>1</arm_group_label>
    <other_name>SD-IIV4</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women were not randomized. A modified-cluster randomization scheme was used. Facilities&#xD;
        were assigned to blocks and were randomized within blocks, ensuring that roughly half the&#xD;
        facilities within each block initially administer one vaccine of the 2 vaccines planned in&#xD;
        the study, and the other half administer the alternate vaccine. Iteratively, over time, the&#xD;
        vaccine administered within each facility will then alternate.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
        Pregnant women:&#xD;
&#xD;
          -  Laboratory or medical professional confirmation of pregnancy&#xD;
&#xD;
          -  Exposure to either Flublok Quadrivalent influenza vaccine or standard-dose&#xD;
             quadrivalent inactivated influenza vaccine (SD-IIV4) in the VAP00003 Study during&#xD;
             pregnancy or within 28 days preceding conception&#xD;
&#xD;
        Offspring:&#xD;
&#xD;
          -  Infants delivered by pregnant women who satisfy the criteria above Exclusion criteria&#xD;
&#xD;
          -  Documented receipt of any other influenza vaccine at any other time during the&#xD;
             pregnancy&#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>64 Years</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 Pasteur, a Sanofi Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kaiser Permanente Northern California</name>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <zip>94612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>May 23, 2022</last_update_submitted>
  <last_update_submitted_qc>May 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2022</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>Influenza, Human</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>
  <!-- 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/NCT04460781
org study id: VAP00007
nct id: NCT04460781
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Primary Objective:

      To evaluate the safety of Flublok Quadrivalent influenza vaccine in pregnant women included
      in the VAP00003 Study (NCT03694392) and their offspring exposed during pregnancy or up to 28
      days preceding the estimated date of conception with regards to pregnancy, birth, and
      neonatal/infant outcomes

      Secondary Objective:
Data will be recorded prospectively during the safety follow-up for pregnant women until
      delivery (or pregnancy outcome, whichever is later), and for infants of pregnant women for 1
      year after birth.
observational model: Cohort
time perspective: Prospective
measure: Incidence Rates of Pregnancy Outcome Events
time frame: From start of pregnancy or up to 28 days prior to conception until delivery or pregnancy outcome
description: Pregnancy outcome events: spontaneous abortion, preterm labor, stillbirth/Fetal death, congenital/fetal anomalies detected during pregnancy, eclampsia, and placental abruption
measure: Incidence Rates of Birth Events
time frame: At birth
description: Preterm birth, low birth weight or small for gestational age observed or diagnosed at birth
measure: Incidence Rates of Neonatal/ Infant Outcomes
time frame: From birth to Day 365 post-birth
description: Neonatal/ infant outcomes: infant death, any congenital anomalies detected after delivery, and failure to thrive
arm group label: 1
description: Pregnant women from the VAP00003 Study and their offspring - Pregnant women from the VAP00003 Study (NCT03694392) between September 2018 and May 2020 (2 influenza seasons), and infants born from this cohort of pregnant women
intervention type: Biological
intervention name: Flublok Quadrivalent influenza vaccine RIV4
description: Route of administration: Intramuscular
arm group label: 1
other name: RIV4
intervention type: Biological
intervention name: Standard-dose quadrivalent inactivated influenza vaccine SD-IIV4
description: Route of administration: Intramuscular
arm group label: 1
other name: SD-IIV4
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 64 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Clinical Sciences & Operations
role: Study Director
affiliation: Sanofi Pasteur, a Sanofi Company
facility: 
country: United States
responsible party type: Sponsor
mesh term: Influenza, Human
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