<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/NCT01698346</url>
  </required_header>
  <id_info>
    <org_study_id>cev001</org_study_id>
    <secondary_id>2011-001936-45</secondary_id>
    <nct_id>NCT01698346</nct_id>
  </id_info>
  <brief_title>Pertussis (Tdap) Vaccination in Pregnancy</brief_title>
  <official_title>Impact of Pertussis Vaccination in Pregnancy on Maternal Protection Offered to Young Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universiteit Antwerpen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Hygiene and Epidemiology, Vietnam</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universiteit Antwerpen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Despite good vaccination coverage, included in national immunization programs in developed&#xD;
      countries, the number of reported pertussis cases is rising, also in very young infants.&#xD;
      Current immunization strategies fail to protect infants too young to be immunized with the&#xD;
      licensed vaccine. Different strategies are possible to close the gap of susceptibility&#xD;
      between the loss of maternal antibodies and protection by vaccination. The main aim of the&#xD;
      present study is to measure the influence of an adult pertussis booster in pregnant women, on&#xD;
      the titer and duration of maternal antibodies in their infants. Early humoral immunity will&#xD;
      be assessed and the influence on vaccine response of the infant measured. The present study&#xD;
      offers the opportunity to have new insights in neonatal immunological mechanisms against&#xD;
      pertussis and a better understanding in strategies to protect infants against pertussis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Does vaccination of pregnant women with a combined vaccine Tetanus, diphtheria and acellular pertussis (Tdap), induce sufficiently high maternal antibody concentration in the newborns infants to possibly protect them until their own vaccination starts</measure>
    <time_frame>16 months</time_frame>
    <description>What are the concentrations of IgG against Pertussis Toxin (anti-PT), Filamentous Haemagglutinin (anti-FHA), Fimbriae (anti-Fim) and pertactin (anti-PRN):&#xD;
in women during pregnancy and at delivery after vaccination with TdaP&#xD;
in children at birth (cord), before starting vaccination (week 8), one month after primary course of three doses (week 20) and before and after the fourth pertussis vaccine dose (at month 15 and 16)&#xD;
What are the concentrations of anti-tetanus and anti-diphtheria IgG antibodies at all mentioned time points, to evaluate interference when administering several antigens and to evaluate the influence of maternal antibodies on vaccine response to tetanus and diphtheria in infants</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Vaccine associated (Severe) Adverse Events ((S)AE) in pregnant women and children during the study time</measure>
    <time_frame>16 months</time_frame>
    <description>Vaccine associated (Severe) Adverse Events ((S)AE) in pregnant women and children during the study time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant growth measurement at all time points</measure>
    <time_frame>16 months</time_frame>
    <description>Infant growth measurement at all time points</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of pneumococcal immune response in infants whose mothers received Tdap vaccination during pregnancy</measure>
    <time_frame>12 months</time_frame>
    <description>The present trial on pertussis vaccination during pregnancy, offers the opportunity to add evidence for a possible blunting effect of infant immune responses to pneumococcal infant vaccination after maternal Tdap vaccination. Pneumococcal antibodies will be measured in serum samples taken from infants after a primary series of 2 pneumococcal vaccine doses (2 and 4 months of age) and after a third vaccine dose (at 12 months of age). Infants are born from either vaccinated or unvaccinated mothers.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">99</enrollment>
  <condition>Pertussis</condition>
  <condition>Pregnancy</condition>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>50 unvaccinated pregnant women</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pertussis vaccine (Boostrix®, GSK Biologicals, Rixensart)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>50 pregnant women vaccinated with pertussis vaccine</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Pertussis vaccine</intervention_name>
    <description>Vaccination during pregnancy with a pertussis containing vaccine</description>
    <arm_group_label>Pertussis vaccine (Boostrix®, GSK Biologicals, Rixensart)</arm_group_label>
    <other_name>Boostrix®, GSK Biologicals, Rixensart</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women aged 18-35 years&#xD;
&#xD;
          -  Willing to be immunized during pregnancy OR&#xD;
&#xD;
          -  Received already a pertussis vaccination during pregnancy, as advised by gynaecologist&#xD;
             or general practitioner.&#xD;
&#xD;
          -  Age matched controls will be identified in the same time period in the recruiting&#xD;
             hospital.&#xD;
&#xD;
          -  Availability for follow-up visits and phone call access through 16 months following&#xD;
             delivery&#xD;
&#xD;
          -  Willing to have infant immunized with hexavalent vaccine at 8.12 and 16 weeks and 15&#xD;
             months of age (= normal Belgian schedule) with pediatrician, the general practitioner&#xD;
             or at the Centre for the Evaluation of Vaccination.&#xD;
&#xD;
          -  In the 18th-32nd week of a pregnancy at low risk for complications as determined by&#xD;
             the obstetrician&#xD;
&#xD;
        Exclusion Criteria:Women:&#xD;
&#xD;
          -  Serious underlying medical condition&#xD;
&#xD;
          -  History of a febrile illness (&gt;= 38° Celsius) within the past 72 hours before&#xD;
             injection&#xD;
&#xD;
          -  Previous severe reaction to any vaccine&#xD;
&#xD;
          -  Receipt of tetanus-diphtheria toxoid immunization within the past 1 month&#xD;
&#xD;
          -  Receipt of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine&#xD;
             absorbed (Tdap) immunization in the last 10 years&#xD;
&#xD;
          -  Receipt of a vaccine, blood product (excluding Rhogam) or experimental medicine within&#xD;
             the 4 weeks prior to injection through 4 weeks following injection&#xD;
&#xD;
          -  Receipt of or plans to receive influenza vaccine within the 4weeks prior to or&#xD;
             following injection. One month interval should be respected in order to evaluate&#xD;
             eventual Adverse events following one of both vaccines (fever, local symptoms).&#xD;
&#xD;
          -  High risk for serious obstetrical complication&#xD;
&#xD;
          -  Anything in the opinion of the investigator that would put the participant at risk.&#xD;
&#xD;
        Exclusion criteria for the offspring:&#xD;
&#xD;
          -  Serious underlying medical condition&#xD;
&#xD;
          -  No signed informed consent by both parents&#xD;
&#xD;
          -  Severe reactions to any vaccine&#xD;
&#xD;
          -  Anything in the opinion of the investigator that would put the participant at risk.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elke Leuridan, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universiteit Antwerpen</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Thu Ha Thi Hoang, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Institute for Hygiene and Epidemiology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre for the Evaluation of Vaccination</name>
      <address>
        <city>Antwerp</city>
        <zip>2610</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Institute of Hygien and Epidemiology</name>
      <address>
        <city>Hanoi</city>
        <zip>10000</zip>
        <country>Vietnam</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Vietnam</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>September 21, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>October 22, 2019</last_update_submitted>
  <last_update_submitted_qc>October 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universiteit Antwerpen</investigator_affiliation>
    <investigator_full_name>Elke Leuridan, MD, PhD</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Pertussis</keyword>
  <keyword>Infants</keyword>
  <keyword>Vaccination</keyword>
  <keyword>Pregnancy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Whooping Cough</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/NCT01698346
org study id: cev001
secondary id: 2011-001936-45
nct id: NCT01698346
lead sponsor: 
collaborator: 
has dmc: No
Despite good vaccination coverage, included in national immunization programs in developed
      countries, the number of reported pertussis cases is rising, also in very young infants.
      Current immunization strategies fail to protect infants too young to be immunized with the
      licensed vaccine. Different strategies are possible to close the gap of susceptibility
      between the loss of maternal antibodies and protection by vaccination. The main aim of the
      present study is to measure the influence of an adult pertussis booster in pregnant women, on
      the titer and duration of maternal antibodies in their infants. Early humoral immunity will
      be assessed and the influence on vaccine response of the infant measured. The present study
      offers the opportunity to have new insights in neonatal immunological mechanisms against
      pertussis and a better understanding in strategies to protect infants against pertussis.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Does vaccination of pregnant women with a combined vaccine Tetanus, diphtheria and acellular pertussis (Tdap), induce sufficiently high maternal antibody concentration in the newborns infants to possibly protect them until their own vaccination starts
time frame: 16 months
description: What are the concentrations of IgG against Pertussis Toxin (anti-PT), Filamentous Haemagglutinin (anti-FHA), Fimbriae (anti-Fim) and pertactin (anti-PRN):
in women during pregnancy and at delivery after vaccination with TdaP
in children at birth (cord), before starting vaccination (week 8), one month after primary course of three doses (week 20) and before and after the fourth pertussis vaccine dose (at month 15 and 16)
What are the concentrations of anti-tetanus and anti-diphtheria IgG antibodies at all mentioned time points, to evaluate interference when administering several antigens and to evaluate the influence of maternal antibodies on vaccine response to tetanus and diphtheria in infants
measure: Vaccine associated (Severe) Adverse Events ((S)AE) in pregnant women and children during the study time
time frame: 16 months
description: Vaccine associated (Severe) Adverse Events ((S)AE) in pregnant women and children during the study time
measure: Infant growth measurement at all time points
time frame: 16 months
description: Infant growth measurement at all time points
measure: Assessment of pneumococcal immune response in infants whose mothers received Tdap vaccination during pregnancy
time frame: 12 months
description: The present trial on pertussis vaccination during pregnancy, offers the opportunity to add evidence for a possible blunting effect of infant immune responses to pneumococcal infant vaccination after maternal Tdap vaccination. Pneumococcal antibodies will be measured in serum samples taken from infants after a primary series of 2 pneumococcal vaccine doses (2 and 4 months of age) and after a third vaccine dose (at 12 months of age). Infants are born from either vaccinated or unvaccinated mothers.
arm group label: control
arm group type: No Intervention
description: 50 unvaccinated pregnant women
arm group label: Pertussis vaccine (Boostrix®, GSK Biologicals, Rixensart)
arm group type: Active Comparator
description: 50 pregnant women vaccinated with pertussis vaccine
intervention type: Biological
intervention name: Pertussis vaccine
description: Vaccination during pregnancy with a pertussis containing vaccine
arm group label: Pertussis vaccine (Boostrix®, GSK Biologicals, Rixensart)
other name: Boostrix®, GSK Biologicals, Rixensart
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Elke Leuridan, MD, PhD
role: Principal Investigator
affiliation: Universiteit Antwerpen
last name: Thu Ha Thi Hoang, MD PhD
role: Principal Investigator
affiliation: National Institute for Hygiene and Epidemiology
facility: 
facility: 
country: Belgium
country: Vietnam
responsible party type: Principal Investigator
investigator affiliation: Universiteit Antwerpen
investigator full name: Elke Leuridan, MD, PhD
investigator title: MD, PhD
mesh term: Whooping Cough