<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/NCT02209623</url>
  </required_header>
  <id_info>
    <org_study_id>CISA 2014 Task III</org_study_id>
    <nct_id>NCT02209623</nct_id>
  </id_info>
  <brief_title>TDAP Safety in Pregnant Women</brief_title>
  <acronym>Tdap</acronym>
  <official_title>Clinical Study of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine (Tdap) Safety in Pregnant Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centers for Disease Control and Prevention</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Vanderbilt University Medical Center</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this observational study is to evaluate the safety of Tetanus Toxoid Reduced&#xD;
      Diphtheria, Toxoid, and Acelluar Pertussis Vaccine (Tdap) in pregnant women at ≥ 20 weeks 0&#xD;
      days gestation receiving Tdap as part of standard practice. Prior Tdap/Td/TT history will be&#xD;
      verified by medical record review when possible. There will be an emphasis on enrolling women&#xD;
      who have received Tdap before the current pregnancy, to the greatest extent possible.&#xD;
      Non-pregnant women who are receiving their initial Tdap will also be recruited.&#xD;
&#xD;
      Injection-site (local) and systemic reaction data will be assessed on the vaccination day and&#xD;
      during the 7 days following vaccination using either identical web-based or paper diaries,&#xD;
      depending on the preference of the study participant.&#xD;
&#xD;
      Pregnant women will be followed until delivery with comprehensive obstetric and neonatal&#xD;
      outcomes obtained from review of the electronic medical record.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an observational study of both pregnant and non-pregnant women. Vaccine&#xD;
      administration in the pregnant population will be part of routine care. Vaccine&#xD;
      administration in the non-pregnant women will be provided as either routine care or as part&#xD;
      of the study. Pregnant women at ≥ 20 weeks 0 days gestation who have not received Tdap during&#xD;
      the current pregnancy will be enrolled, with prioritized emphasis on enrolling pregnant women&#xD;
      who have received Tdap prior to the current pregnancy in order to attempt to address the&#xD;
      question of closely-spaced repeated dosing. Detailed data will be collected from study&#xD;
      participants on prior Tdap/Td/TT receipt. The non-pregnant women will consist of both Tdap&#xD;
      naïve and those who have received Tdap previously. With Day 0 serving as the day of&#xD;
      vaccination, participants will be followed through Day 7 for symptoms of reactogenicity. For&#xD;
      Primary Objective 1, symptoms of reactogenicity occurring from Day 0 -7 will be compared&#xD;
      between pregnant and non-pregnant women. For Objective 2, pregnant women will be followed&#xD;
      through delivery for collection of pregnancy outcome data. Pregnancy outcomes among study&#xD;
      participants will be compared with historical outcomes from summary data from both Vanderbilt&#xD;
      and Duke. In addition, follow-up will be conducted for infants born to mothers who received&#xD;
      Tdap during pregnancy to assess health outcomes and growth parameters through 6 months of&#xD;
      life.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2014</start_date>
  <completion_date type="Actual">December 18, 2017</completion_date>
  <primary_completion_date type="Actual">May 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Rates of injection-site and systemic reactions post Tdap administration.</measure>
    <time_frame>7 days post administration</time_frame>
    <description>Rates of injection-site and systemic reactions after Tdap in pregnant women versus non-pregnant women will be compared.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rates of preterm and small for gestational age (SGA) births in women who received Tdap prenatally</measure>
    <time_frame>7 days post delivery</time_frame>
    <description>Rates of preterm and small for gestational age (SGA) births in women who received Tdap prenatally will be evaluated by review of the hospital delivery record following delivery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Differences in injection-site and systemic reactions in pregnant women who received Tdap before the current pregnancy versus women who are receiving their first Tdap dose</measure>
    <time_frame>7 days post vaccination</time_frame>
    <description>Differences in injection-site and systemic reactions in pregnant women who received Tdap before the current pregnancy versus women who are receiving their first Tdap dose will be explored.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of additional obstetrical and infant outcomes in pregnant women receiving Tdap</measure>
    <time_frame>7 days post delivery</time_frame>
    <description>To assess rates of additional obstetrical and infant outcomes in pregnant women receiving Tdap including, but not limited to, maternal or fetal death, placental abruption, postpartum hemorrhage, pregnancy related hypertension, gestational diabetes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health outcomes and growth parameters among infants born to women who received Tdap during pregnancy</measure>
    <time_frame>6 months post delivery</time_frame>
    <description>To describe health outcomes and growth parameters through 6 months of life among infants born to women who received Tdap during pregnancy</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Measurement of serum cytokines before and after severe, local and systemic reactions</measure>
    <time_frame>28 days post vaccination</time_frame>
    <description>Levels of cytokines will also be compared across groups (pregnant vs. non-pregnant women)</description>
  </other_outcome>
  <other_outcome>
    <measure>Measurement of serum antibody levels to pertussis toxin, filamentous hemagglutinin, pertactin, fimbria and diphtheria and tetanus toxins</measure>
    <time_frame>28 days post vaccination</time_frame>
    <description>Antibody responses pre and post-vaccination will be compared between pregnant and non-pregnant women to each pertussis vaccine antigen</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">375</enrollment>
  <condition>Pertussis</condition>
  <arm_group>
    <arm_group_label>Pregnant Women receiving TDAP</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>TDAP</intervention_name>
    <arm_group_label>Pregnant Women receiving TDAP</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum Samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        375 healthy pregnant women at ≥ 20 weeks 0 days gestation through ≤ 34 weeks 0 days&#xD;
        gestation and their infants and 225 healthy non-pregnant women, age range 18-45 years&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion:&#xD;
&#xD;
        Subjects who meet the following criteria will be eligible to participate in this&#xD;
        observational study. Tdap administration will be given as routine standard of care.&#xD;
&#xD;
          -  Pregnant and non-pregnant women, as determined by medical history, aged 18 - 45 years&#xD;
             of age inclusive&#xD;
&#xD;
          -  For pregnant women only - Singleton gestation ≥ 20 weeks 0 days gestation - ≤34 weeks&#xD;
             0 days gestation based on reconciliation of last menstrual period and ultrasound&#xD;
             dating. Estimated due date (EDD) and Gestational Age (GA) - EDD will be based on&#xD;
             reconciliation of a &quot;sure&quot; first day of the last menstrual period (LMP) and earliest&#xD;
             dating ultrasound. If the LMP is uncertain, then the earliest dating ultrasound will&#xD;
             be used to determine EDD and GA. If the ultrasound derived-EDD is in agreement with&#xD;
             sure-LMP derived EDD, then the LMP-derived EDD is used to determine GA. If the&#xD;
             ultrasound derived EDD is not in agreement with the LMP-derived EDD, the&#xD;
             ultrasound-derived EDD is used to determine GA.&#xD;
&#xD;
          -  Intention of receiving Tdap vaccine based on ACIP guidelines&#xD;
&#xD;
          -  Willing to provide written informed consent prior to initiation of any study&#xD;
             procedures&#xD;
&#xD;
          -  English or Spanish literate&#xD;
&#xD;
          -  Intention of being available for entire study period and complete all relevant study&#xD;
             procedures&#xD;
&#xD;
        Exclusion:&#xD;
&#xD;
          -  Subjects who meet the following criteria will not be eligible to participate in this&#xD;
             study:&#xD;
&#xD;
          -  Febrile illness within the last 24 hours or an oral temperature &gt; 100.4oF (&gt; 38oC)&#xD;
             prior to Tdap administration&#xD;
&#xD;
          -  Severe allergic reaction (e.g., anaphylaxis) to any component of Tdap or any other&#xD;
             diphtheria toxoid, tetanus toxoid and pertussis antigen containing vaccine&#xD;
&#xD;
          -  Encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures)&#xD;
             within 7 days of administration of a previous pertussis antigen-containing vaccine.&#xD;
&#xD;
          -  Known or suspected impairment of immunologic function including active infection with&#xD;
             HIV, hepatitis B or C, current use of glucocorticoids, i.e., oral, parenteral, and&#xD;
             high-dose inhaled steroids, and immunosuppressive or cytotoxic drugs.&#xD;
&#xD;
          -  Note, if a woman were to require antenatal corticosteroids for benefit of fetal lung&#xD;
             maturity within 8 days post enrollment, she would not be excluded from the study for&#xD;
             reactogenicity analysis. However, if antenatal corticosteroids were received anytime&#xD;
             between vaccination and 28-day sample collection for serologic studies, she would be&#xD;
             excluded from serologic studies as they could be altered by steroid receipt.&#xD;
&#xD;
          -  Receipt of any licensed vaccine OR investigational product within 1 week prior to Tdap&#xD;
             vaccination in this study or planning receipt of any vaccines during 8-day&#xD;
             post-vaccination period.&#xD;
&#xD;
          -  Note, any woman receiving an investigational vaccine or live vaccine inadvertently at&#xD;
             any time during pregnancy will be excluded from analysis. (Note, inadvertent receipt&#xD;
             of licensed HPV vaccine or any other inactivated licensed vaccine outside of the&#xD;
             parameters specified above is not a reason for exclusion).&#xD;
&#xD;
          -  Any condition which, in the opinion of the investigators, may pose a health risk to&#xD;
             the subject or interfere with the evaluation of the study objectives.&#xD;
&#xD;
          -  Anyone who is a relative of any research study personnel&#xD;
&#xD;
          -  Anyone who is an employee of any research study personnel&#xD;
&#xD;
          -  For pregnant women only&#xD;
&#xD;
          -  Tdap/Td/TT receipt during current pregnancy prior to study enrollment&#xD;
&#xD;
          -  Signs or symptoms of active preterm labor, defined as regular uterine contractions&#xD;
             with cervical change&#xD;
&#xD;
          -  For non-pregnant women only&#xD;
&#xD;
          -  Intention of becoming pregnant during study participation&#xD;
&#xD;
          -  Anyone who is already enrolled or plans to enroll in another clinical trial with an&#xD;
             investigational product within 30 days of Tdap receipt. Co-enrollment in observational&#xD;
             or behavioral intervention studies are allowed at any time while enrollment in a&#xD;
             clinical trial involving an investigational product (other than vaccine) may occur&#xD;
             after 30 days following Tdap receipt. Receipt of inactivated vaccines during&#xD;
             pregnancy, including routinely recommended inactivated influenza vaccine, given as&#xD;
             part of usual care, is not an exclusion for this study, except during the 8 days after&#xD;
             Tdap vaccination&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kathryn M Edwards, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Geeta K Swamy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Karen R Broder, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centers for Disease Control and Prevention</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kimberly B Fortner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University Dept of ObGyn, Division of Maternal-Fetal Medicine</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt Medical Center, Vaccine Research Program</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <last_update_submitted>December 18, 2017</last_update_submitted>
  <last_update_submitted_qc>December 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University</investigator_affiliation>
    <investigator_full_name>Kathryn Edwards</investigator_full_name>
    <investigator_title>Professor, Sarah Sell and Cornelius Vanderbilt Chair of Pediatrics</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Whooping Cough</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02209623
org study id: CISA 2014 Task III
nct id: NCT02209623
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this observational study is to evaluate the safety of Tetanus Toxoid Reduced
      Diphtheria, Toxoid, and Acelluar Pertussis Vaccine (Tdap) in pregnant women at ≥ 20 weeks 0
      days gestation receiving Tdap as part of standard practice. Prior Tdap/Td/TT history will be
      verified by medical record review when possible. There will be an emphasis on enrolling women
      who have received Tdap before the current pregnancy, to the greatest extent possible.
      Non-pregnant women who are receiving their initial Tdap will also be recruited.

      Injection-site (local) and systemic reaction data will be assessed on the vaccination day and
      during the 7 days following vaccination using either identical web-based or paper diaries,
      depending on the preference of the study participant.

      Pregnant women will be followed until delivery with comprehensive obstetric and neonatal
      outcomes obtained from review of the electronic medical record.
This is an observational study of both pregnant and non-pregnant women. Vaccine
      administration in the pregnant population will be part of routine care. Vaccine
      administration in the non-pregnant women will be provided as either routine care or as part
      of the study. Pregnant women at ≥ 20 weeks 0 days gestation who have not received Tdap during
      the current pregnancy will be enrolled, with prioritized emphasis on enrolling pregnant women
      who have received Tdap prior to the current pregnancy in order to attempt to address the
      question of closely-spaced repeated dosing. Detailed data will be collected from study
      participants on prior Tdap/Td/TT receipt. The non-pregnant women will consist of both Tdap
      naïve and those who have received Tdap previously. With Day 0 serving as the day of
      vaccination, participants will be followed through Day 7 for symptoms of reactogenicity. For
      Primary Objective 1, symptoms of reactogenicity occurring from Day 0 -7 will be compared
      between pregnant and non-pregnant women. For Objective 2, pregnant women will be followed
      through delivery for collection of pregnancy outcome data. Pregnancy outcomes among study
      participants will be compared with historical outcomes from summary data from both Vanderbilt
      and Duke. In addition, follow-up will be conducted for infants born to mothers who received
      Tdap during pregnancy to assess health outcomes and growth parameters through 6 months of
      life.
observational model: Other
time perspective: Prospective
measure: Rates of injection-site and systemic reactions post Tdap administration.
time frame: 7 days post administration
description: Rates of injection-site and systemic reactions after Tdap in pregnant women versus non-pregnant women will be compared.
measure: Rates of preterm and small for gestational age (SGA) births in women who received Tdap prenatally
time frame: 7 days post delivery
description: Rates of preterm and small for gestational age (SGA) births in women who received Tdap prenatally will be evaluated by review of the hospital delivery record following delivery.
measure: Differences in injection-site and systemic reactions in pregnant women who received Tdap before the current pregnancy versus women who are receiving their first Tdap dose
time frame: 7 days post vaccination
description: Differences in injection-site and systemic reactions in pregnant women who received Tdap before the current pregnancy versus women who are receiving their first Tdap dose will be explored.
measure: Rates of additional obstetrical and infant outcomes in pregnant women receiving Tdap
time frame: 7 days post delivery
description: To assess rates of additional obstetrical and infant outcomes in pregnant women receiving Tdap including, but not limited to, maternal or fetal death, placental abruption, postpartum hemorrhage, pregnancy related hypertension, gestational diabetes
measure: Health outcomes and growth parameters among infants born to women who received Tdap during pregnancy
time frame: 6 months post delivery
description: To describe health outcomes and growth parameters through 6 months of life among infants born to women who received Tdap during pregnancy
measure: Measurement of serum cytokines before and after severe, local and systemic reactions
time frame: 28 days post vaccination
description: Levels of cytokines will also be compared across groups (pregnant vs. non-pregnant women)
measure: Measurement of serum antibody levels to pertussis toxin, filamentous hemagglutinin, pertactin, fimbria and diphtheria and tetanus toxins
time frame: 28 days post vaccination
description: Antibody responses pre and post-vaccination will be compared between pregnant and non-pregnant women to each pertussis vaccine antigen
arm group label: Pregnant Women receiving TDAP
intervention type: Biological
intervention name: TDAP
arm group label: Pregnant Women receiving TDAP
Serum Samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kathryn M Edwards, MD
role: Principal Investigator
affiliation: Vanderbilt Medical Center
last name: Geeta K Swamy, MD
role: Principal Investigator
affiliation: Duke Medical Center
last name: Karen R Broder, MD
role: Principal Investigator
affiliation: Centers for Disease Control and Prevention
last name: Kimberly B Fortner, MD
role: Principal Investigator
affiliation: Vanderbilt University
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University
investigator full name: Kathryn Edwards
investigator title: Professor, Sarah Sell and Cornelius Vanderbilt Chair of Pediatrics
mesh term: Whooping Cough
sharing ipd: No