<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/NCT01711645</url>
  </required_header>
  <id_info>
    <org_study_id>11-0035</org_study_id>
    <secondary_id>HHSN272201300023I</secondary_id>
    <nct_id>NCT01711645</nct_id>
  </id_info>
  <brief_title>Tdap Vaccine in Post-Partum Women</brief_title>
  <official_title>Phase IV, Open Label Trial to Evaluate Immunogenicity of Tdap Vaccine in Post-Partum Women to Optimize Vaccination Schedule for Women Who May Have a Subsequent Child</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institute of Allergy and Infectious Diseases (NIAID)</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</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>
      Monitoring immune response and longevity in serum and milk after Tdap administration to&#xD;
      postpartum women. The clinical trial will involve women (aged 18 - 45 years) who have just&#xD;
      delivered full-term infants (greater than or equal to 37 completed weeks of gestation) at&#xD;
      Vanderbilt University Medical Center. The enrollment period will be fifteen months. The&#xD;
      duration is over two years of observation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single site, prospective study involving only one intervention, receipt of a single&#xD;
      0.5 mL intramuscular (IM) dose of Adacel (Tetanus toxoid, reduced diphtheria toxoid and&#xD;
      acellular Pertussis) vaccine, among 55 healthy post partum women. The purpose of the study is&#xD;
      to examine the immune responses and subsequent decline in serum and breast milk antibody&#xD;
      titers over two years of observation. The clinical trial will involve women (aged 18 - 45&#xD;
      years) who have just delivered full-term infants (greater than or equal to 37 completed weeks&#xD;
      of gestation) at Vanderbilt University Medical Center. One particular population at&#xD;
      Vanderbilt to target will be the &quot;centering prenatal care group&quot; that has breastfeeding rates&#xD;
      as high as 75 percent at hospital discharge and maintained at 20 percent at 6 months. The&#xD;
      enrollment period will be fifteen months. The subjects, staff assessing subjects, and&#xD;
      laboratory personnel will be aware of receipt of the vaccine. Since only a single vaccine&#xD;
      product is being utilized, there is no blinding needed of the subjects or staff.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 26, 2012</start_date>
  <completion_date type="Actual">August 28, 2015</completion_date>
  <primary_completion_date type="Actual">August 28, 2015</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
  </study_design_info>
  <primary_outcome>
    <measure>Geometric Mean Fold Rise in Serum Immunoglobulin G (IgG) by ELISA at Week 2</measure>
    <time_frame>Prior to and 2 weeks following vaccination</time_frame>
    <description>Blood was collected from participants at baseline prior to vaccination and at 2 weeks after vaccination for assessment of IgG by ELISA against the pertussis toxin (PT), filamentous hemaggluttinin (FHA), pertactin (PRN) and fimbrae (FIM) antigens. Antibody concentrations were reported as ELISA units per milliliter (EU/mL). The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% confidence interval (CI).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Geometric Mean Fold Rise in Serum IgG by ELISA at Week 6</measure>
    <time_frame>Prior to and 6 weeks following vaccination</time_frame>
    <description>Blood was collected from participants at baseline prior to vaccination and at 6 weeks after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% CI.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Geometric Mean Fold Rise in Serum IgG by ELISA at Month 6</measure>
    <time_frame>Prior to and 6 months following vaccination</time_frame>
    <description>Blood was collected from participants at baseline prior to vaccination and at 6 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% CI.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Geometric Mean Fold Rise in Serum IgG by ELISA at Month 12</measure>
    <time_frame>Prior to and 12 months following vaccination</time_frame>
    <description>Blood was collected from participants at baseline prior to vaccination and at 12 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% CI.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Geometric Mean Fold Rise in Serum IgG by ELISA at Month 18</measure>
    <time_frame>Prior to and 18 months following vaccination</time_frame>
    <description>Blood was collected from participants at baseline prior to vaccination and at 18 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% CI.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Geometric Mean Fold Rise in Serum IgG by ELISA at Month 24</measure>
    <time_frame>Prior to and 24 months following vaccination</time_frame>
    <description>Blood was collected from participants at baseline prior to vaccination and at 24 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% CI.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ELISA Geometric Mean Concentrations (GMC) of Serum IgG to PT, FHA, PRN and FIM at Baseline</measure>
    <time_frame>Baseline (prior to vaccination)</time_frame>
    <description>Blood was collected from participants at baseline prior to vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. Antibody concentrations were reported as ELISA units per milliliter (EU/mL). A value of 5 EU/mL was imputed for results reported as below the lower limit of quantitation (LLOQ) (&lt;10 EU/mL). The geometric mean of participants' concentrations at the timepoint was calculated, along with the 95% CI.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Week 2</measure>
    <time_frame>2 weeks post vaccination</time_frame>
    <description>Blood was collected from participants at 2 weeks after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants' concentrations at the timepoint was calculated, along with the 95% CI.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Week 6</measure>
    <time_frame>6 weeks post vaccination</time_frame>
    <description>Blood was collected from participants at 6 weeks after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants' concentrations at the timepoint was calculated, along with the 95% CI.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 6</measure>
    <time_frame>6 months post vaccination</time_frame>
    <description>Blood was collected from participants at 6 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants' concentrations at the timepoint was calculated, along with the 95% CI.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 12</measure>
    <time_frame>12 months post vaccination</time_frame>
    <description>Blood was collected from participants at 12 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants' concentrations at the timepoint was calculated, along with the 95% CI.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 18</measure>
    <time_frame>18 months post vaccination</time_frame>
    <description>Blood was collected from participants at 18 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants' concentrations at the timepoint was calculated, along with the 95% CI.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 24</measure>
    <time_frame>24 months post vaccination</time_frame>
    <description>Blood was collected from participants at 24 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants' concentrations at the timepoint was calculated, along with the 95% CI.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Week 2</measure>
    <time_frame>Prior to and 2 weeks after vaccination</time_frame>
    <description>Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 2 weeks after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Week 6</measure>
    <time_frame>Prior to and 6 weeks after vaccination</time_frame>
    <description>Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 6 weeks after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 6</measure>
    <time_frame>Prior to and 6 months after vaccination</time_frame>
    <description>Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 6 months after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 12</measure>
    <time_frame>Prior to and 12 months after vaccination</time_frame>
    <description>Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 12 months after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 18</measure>
    <time_frame>Prior to and 18 months after vaccination</time_frame>
    <description>Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 18 months after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 24</measure>
    <time_frame>Prior to and 24 months after vaccination</time_frame>
    <description>Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 24 months after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Kinetics of the ELISA IgG Antibody Rise in Serum</measure>
    <time_frame>Prior to and following Tdap, through 24 months post-vaccination</time_frame>
    <description>The assessment of the kinetics of the ELISA IgG antibody rise in serum was defined by the protocol as the geometric mean fold rise at each timepoint (reported separately above). No additional analysis was pre-defined or performed for this outcome measure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ELISA GMC of Breast Milk IgA to Pertussis Toxin (PT) at Baseline.</measure>
    <time_frame>Baseline (prior to vaccination)</time_frame>
    <description>Breast milk (colostrum) was collected from participants at baseline prior to vaccination for assessment of secretory IgA (sIgA) to the PT antigen by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL along with the 95% confidence interval. The lower limit of quantitation (LLOQ) of the assay was 10. Results of &lt;10 were reported as half the LLOQ (5).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ELISA GMC of Breast Milk IgA to PT at Week 2</measure>
    <time_frame>2 weeks post vaccination</time_frame>
    <description>Breast milk was collected from participants at 2 weeks after vaccination for assessment of secretory IgA (sIgA) to PT and FHA by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL. Note that for the PT at this timepoint, all participants had a value of 5, the imputed value for below the LLOQ of the assay (&lt;10), and so the 95% CI is not reported, as there was no measurable variability in the data. The range is reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ELISA GMC of Breast Milk IgA to PT at Week 6</measure>
    <time_frame>6 weeks post vaccination</time_frame>
    <description>Breast milk was collected from participants at 6 weeks after vaccination for assessment of secretory IgA (sIgA) to PT and FHA by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL. Note that for the PT at this timepoint, all participants had a value of 5, the imputed value for below the LLOQ of the assay (&lt;10), and so the 95% CI is not reported, as there was no measurable variability in the data. The range is reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ELISA GMC of Breast Milk IgA to PT at Month 6</measure>
    <time_frame>6 months post vaccination</time_frame>
    <description>Breast milk was collected from participants at 6 weeks after vaccination for assessment of secretory IgA (sIgA) to PT and FHA by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL. Note that for the PT at this timepoint, all participants had a value of 5, the imputed value for below the LLOQ of the assay (&lt;10), and so the 95% CI is not reported, as there was no measurable variability in the data. The range is reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ELISA GMC of Breast Milk IgA to FHA at Baseline.</measure>
    <time_frame>Baseline (prior to vaccination)</time_frame>
    <description>Breast milk (colostrum) was collected from participants at baseline prior to vaccination for assessment of secretory IgA (sIgA) to the FHA antigen by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL along with the 95% confidence interval.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ELISA GMC of Breast Milk IgA to FHA at Week 2.</measure>
    <time_frame>2 weeks post vaccination</time_frame>
    <description>Breast milk was collected from participants at 2 weeks post vaccination for assessment of secretory IgA (sIgA) to the FHA antigen by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL along with the 95% confidence interval.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ELISA GMC of Breast Milk IgA to FHA at Week 6.</measure>
    <time_frame>6 weeks post vaccination</time_frame>
    <description>Breast milk was collected from participants at 6 weeks post vaccination for assessment of secretory IgA (sIgA) to the FHA antigen by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL. Note that for the FHA at this timepoint, all participants had a concentration of 5, the imputed value for below the LLOQ of the assay (&lt;10), and so the 95% CI is not reported, as there was no measurable variability in the data. The range is reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ELISA GMC of Breast Milk IgA to FHA at Month 6.</measure>
    <time_frame>6 months post vaccination</time_frame>
    <description>Breast milk was collected from participants at 6 months post vaccination for assessment of secretory IgA (sIgA) to the FHA antigen by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL along with the 95% confidence interval.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ELISA GMC of Breast Milk IgA to PRN and FIM by Study Day.</measure>
    <time_frame>Baseline (prior to vaccination), Week 2, Week 6 and Month 6 post vaccination</time_frame>
    <description>Breast milk (colostrum) was collected from participants at baseline prior to vaccination for assessment of secretory IgA (sIgA) to the PRN and FIM antigen by ELISA. Available data at the timepoint were to be summarized by geometric mean of the concentration as reported in EU/mL along with the 95% confidence interval. The lower limit of quantitation (LLOQ) of the assay was 10 EU/mL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants With 4-fold Rise in Antibody in Breast Milk by Study Day.</measure>
    <time_frame>Prior to vaccination, 2 weeks, 6 weeks, and 6 months after vaccination</time_frame>
    <description>Breast milk samples were collected from participants for evaluation of PT and FHA secretory IgA (sIgA) by ELISA. The lower limit of quantification (LLOQ) for the assay was 10 EU/mL. A 4-fold rise in concentration from prior to vaccination was defined as a post-vaccination sIgA concentration greater than or equal to 40 EU/mL for participants with baseline sIgA concentrations less than the LLOQ, or 4 times the baseline sIgA concentration for baseline sIgA concentrations greater than the LLOQ.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Fold Rise in Antibody Concentrations Assessed by ELISA in Breast Milk by Study Day</measure>
    <time_frame>Prior to vaccination, 2 weeks, 6 weeks, and 6 months after vaccination</time_frame>
    <description>Breast milk samples were collected from participants for evaluation of secretory IgA (sIgA) by ELISA. Geometric mean fold rise was defined as the geometric mean of participants' fold rise in post vaccination sIgA relative to the pre-vaccination sIgA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kinetics of the ELISA IgG Antibody Decline in Breast Milk Expressed in EU/ml.</measure>
    <time_frame>Prior to vaccination, 2 weeks, 6 weeks, and 6 months after vaccination</time_frame>
    <description>Breast milk samples were collected from participants for evaluation of PT and FHA secretory IgA (sIgA) by ELISA. The protocol defined kinetics as assessment at each post-vaccination timepoint of the geometric mean fold rise, defined as the geometric mean of participants' fold rise in post vaccination sIgA relative to the pre-vaccination sIgA.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Diphtheria</condition>
  <condition>Pertussis</condition>
  <condition>Tetanus</condition>
  <arm_group>
    <arm_group_label>Adacel® Tdap vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>55 postpartum subjects receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed).</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed onto aluminum phosphate</intervention_name>
    <description>55 postpartum subjects receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed).</description>
    <arm_group_label>Adacel® Tdap vaccine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -Healthy, postpartum women as determined by medical history aged 18 - 45 years of age&#xD;
        inclusive. -Women 1-4 days postpartum from delivery of full-term infants. Full-term will be&#xD;
        defined as estimated gestational age of greater than or equal to 37 completed weeks of&#xD;
        pregnancy determined by menstrual dating and concordant with ultrasound findings as per&#xD;
        ACOG bulletin #101). -Provide written informed consent prior to initiation of any study&#xD;
        procedures. -Available for the entire study period. -Able to understand and complete all&#xD;
        relevant study procedures during study participation (women who ultimately have limited&#xD;
        ability to breast feed after enrollment will not be excluded from the study).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -Prior receipt of a tetanus or diphtheria-containing vaccine within two years of&#xD;
        enrollment. -Prior receipt of a tetanus and diphtheria toxoid and acellular pertussis&#xD;
        vaccine within two years of enrollment. -Known or suspected impairment of immunologic&#xD;
        function. -Febrile illness within the last 24 hours or an oral temperature &gt;/= 100.4&#xD;
        degrees F (&gt;/= 38 degrees C) at the time of enrollment. -History of documented tetanus,&#xD;
        diphtheria, or pertussis disease within the preceding 5 years. -History of allergic or&#xD;
        adverse reaction to diphtheria, tetanus, or pertussis vaccines. -Receipt of any steroids,&#xD;
        immunoglobulins, other blood products/transfusion within the past six months- excluding Rh&#xD;
        immunoglobulin (Rhogam™ and Rhophylac™). -Is enrolled or plans to enroll in another&#xD;
        clinical trial with an investigational product while participating in this study&#xD;
        (observational studies are allowed). -Known active infection with HIV, hepatitis B, or&#xD;
        hepatitis C. -History of alcohol or drug abuse in the last 5 years. -Any condition which,&#xD;
        in the opinion of the investigators, may pose a health risk to the subject or interfere&#xD;
        with the evaluation of the study objectives. -Any woman with health condition who is&#xD;
        currently taking glucocorticoids, i.e., oral, parenteral, and high-dose inhaled steroids,&#xD;
        and immunosuppressive or cytotoxic drugs. -Sensitive to latex, based on package insert&#xD;
        -Progressive or unstable neurologic condition, based on package insert. -Receipt of&#xD;
        influenza or other vaccines concomitantly administered or for 42 days following Adacel,&#xD;
        based on package insert.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232-2573</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 8, 2015</verification_date>
  <study_first_submitted>October 18, 2012</study_first_submitted>
  <study_first_submitted_qc>October 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 22, 2012</study_first_posted>
  <results_first_submitted>November 23, 2016</results_first_submitted>
  <results_first_submitted_qc>March 23, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">May 5, 2017</results_first_posted>
  <last_update_submitted>March 23, 2017</last_update_submitted>
  <last_update_submitted_qc>March 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acellular</keyword>
  <keyword>Adacel®</keyword>
  <keyword>Diptheria toxoids</keyword>
  <keyword>Pertussis</keyword>
  <keyword>postpartum</keyword>
  <keyword>Tdap</keyword>
  <keyword>Tetanus</keyword>
  <keyword>women</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Whooping Cough</mesh_term>
    <mesh_term>Tetanus</mesh_term>
    <mesh_term>Diphtheria</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aluminum phosphate</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Postpartum participants were recruited within 1-4 days of full-term delivery in the Nashville area between 26Oct2012 and 03Sep2013.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Adacel® Tdap Vaccine</title>
          <description>Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="55"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Adacel® Tdap Vaccine</title>
          <description>Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="55"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30.1" spread="4.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Geometric Mean Fold Rise in Serum Immunoglobulin G (IgG) by ELISA at Week 2</title>
        <description>Blood was collected from participants at baseline prior to vaccination and at 2 weeks after vaccination for assessment of IgG by ELISA against the pertussis toxin (PT), filamentous hemaggluttinin (FHA), pertactin (PRN) and fimbrae (FIM) antigens. Antibody concentrations were reported as ELISA units per milliliter (EU/mL). The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% confidence interval (CI).</description>
        <time_frame>Prior to and 2 weeks following vaccination</time_frame>
        <population>All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>Adacel® Tdap Vaccine</title>
            <description>Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Fold Rise in Serum Immunoglobulin G (IgG) by ELISA at Week 2</title>
          <description>Blood was collected from participants at baseline prior to vaccination and at 2 weeks after vaccination for assessment of IgG by ELISA against the pertussis toxin (PT), filamentous hemaggluttinin (FHA), pertactin (PRN) and fimbrae (FIM) antigens. Antibody concentrations were reported as ELISA units per milliliter (EU/mL). The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% confidence interval (CI).</description>
          <population>All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.</population>
          <units>Fold Rise</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8" lower_limit="3.8" upper_limit="5.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FHA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.6" lower_limit="7.2" upper_limit="10.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PRN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.6" lower_limit="14.4" upper_limit="32.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FIM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.4" lower_limit="12.4" upper_limit="40.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Geometric Mean Fold Rise in Serum IgG by ELISA at Week 6</title>
        <description>Blood was collected from participants at baseline prior to vaccination and at 6 weeks after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% CI.</description>
        <time_frame>Prior to and 6 weeks following vaccination</time_frame>
        <population>All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>Adacel® Tdap Vaccine</title>
            <description>Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Fold Rise in Serum IgG by ELISA at Week 6</title>
          <description>Blood was collected from participants at baseline prior to vaccination and at 6 weeks after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% CI.</description>
          <population>All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.</population>
          <units>Fold Rise</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5" lower_limit="2.9" upper_limit="4.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FHA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7" lower_limit="5.7" upper_limit="8.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PRN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.1" lower_limit="12.5" upper_limit="29.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FIM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.6" lower_limit="11.1" upper_limit="31.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Geometric Mean Fold Rise in Serum IgG by ELISA at Month 6</title>
        <description>Blood was collected from participants at baseline prior to vaccination and at 6 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% CI.</description>
        <time_frame>Prior to and 6 months following vaccination</time_frame>
        <population>All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>Adacel® Tdap Vaccine</title>
            <description>Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Fold Rise in Serum IgG by ELISA at Month 6</title>
          <description>Blood was collected from participants at baseline prior to vaccination and at 6 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% CI.</description>
          <population>All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.</population>
          <units>Fold Rise</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" lower_limit="1.6" upper_limit="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FHA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" lower_limit="3.0" upper_limit="3.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PRN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.1" lower_limit="5.5" upper_limit="12.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FIM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.1" lower_limit="6.2" upper_limit="16.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Geometric Mean Fold Rise in Serum IgG by ELISA at Month 12</title>
        <description>Blood was collected from participants at baseline prior to vaccination and at 12 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% CI.</description>
        <time_frame>Prior to and 12 months following vaccination</time_frame>
        <population>All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>Adacel® Tdap Vaccine</title>
            <description>Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Fold Rise in Serum IgG by ELISA at Month 12</title>
          <description>Blood was collected from participants at baseline prior to vaccination and at 12 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% CI.</description>
          <population>All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.</population>
          <units>Fold Rise</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" lower_limit="1.4" upper_limit="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FHA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" lower_limit="2.2" upper_limit="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PRN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.1" lower_limit="3.6" upper_limit="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FIM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.9" lower_limit="4.3" upper_limit="11.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Geometric Mean Fold Rise in Serum IgG by ELISA at Month 18</title>
        <description>Blood was collected from participants at baseline prior to vaccination and at 18 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% CI.</description>
        <time_frame>Prior to and 18 months following vaccination</time_frame>
        <population>All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>Adacel® Tdap Vaccine</title>
            <description>Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Fold Rise in Serum IgG by ELISA at Month 18</title>
          <description>Blood was collected from participants at baseline prior to vaccination and at 18 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% CI.</description>
          <population>All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.</population>
          <units>Fold Rise</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" lower_limit="1.4" upper_limit="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FHA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4" lower_limit="2.1" upper_limit="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PRN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.6" lower_limit="3.3" upper_limit="6.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FIM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.8" lower_limit="4.3" upper_limit="10.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Geometric Mean Fold Rise in Serum IgG by ELISA at Month 24</title>
        <description>Blood was collected from participants at baseline prior to vaccination and at 24 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% CI.</description>
        <time_frame>Prior to and 24 months following vaccination</time_frame>
        <population>All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>Adacel® Tdap Vaccine</title>
            <description>Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Fold Rise in Serum IgG by ELISA at Month 24</title>
          <description>Blood was collected from participants at baseline prior to vaccination and at 24 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% CI.</description>
          <population>All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.</population>
          <units>Fold Rise</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" lower_limit="1.2" upper_limit="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FHA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" lower_limit="1.9" upper_limit="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PRN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.9" lower_limit="3.3" upper_limit="7.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FIM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.0" lower_limit="4.0" upper_limit="12.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>ELISA Geometric Mean Concentrations (GMC) of Serum IgG to PT, FHA, PRN and FIM at Baseline</title>
        <description>Blood was collected from participants at baseline prior to vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. Antibody concentrations were reported as ELISA units per milliliter (EU/mL). A value of 5 EU/mL was imputed for results reported as below the lower limit of quantitation (LLOQ) (&lt;10 EU/mL). The geometric mean of participants' concentrations at the timepoint was calculated, along with the 95% CI.</description>
        <time_frame>Baseline (prior to vaccination)</time_frame>
        <population>All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>Adacel® Tdap Vaccine</title>
            <description>Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose</description>
          </group>
        </group_list>
        <measure>
          <title>ELISA Geometric Mean Concentrations (GMC) of Serum IgG to PT, FHA, PRN and FIM at Baseline</title>
          <description>Blood was collected from participants at baseline prior to vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. Antibody concentrations were reported as ELISA units per milliliter (EU/mL). A value of 5 EU/mL was imputed for results reported as below the lower limit of quantitation (LLOQ) (&lt;10 EU/mL). The geometric mean of participants' concentrations at the timepoint was calculated, along with the 95% CI.</description>
          <population>All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.</population>
          <units>EU/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.6" lower_limit="5.7" upper_limit="7.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FHA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.9" lower_limit="12.6" upper_limit="20.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PRN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.3" lower_limit="14.1" upper_limit="29.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FIM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.1" lower_limit="23.4" upper_limit="62.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Week 2</title>
        <description>Blood was collected from participants at 2 weeks after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants' concentrations at the timepoint was calculated, along with the 95% CI.</description>
        <time_frame>2 weeks post vaccination</time_frame>
        <population>All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>Adacel® Tdap Vaccine</title>
            <description>Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose</description>
          </group>
        </group_list>
        <measure>
          <title>ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Week 2</title>
          <description>Blood was collected from participants at 2 weeks after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants' concentrations at the timepoint was calculated, along with the 95% CI.</description>
          <population>All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.</population>
          <units>EU/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.5" lower_limit="39.2" upper_limit="67.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FHA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="154.3" lower_limit="132.3" upper_limit="179.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PRN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="581.5" lower_limit="430.4" upper_limit="785.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FIM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1156.3" lower_limit="794.2" upper_limit="1683.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Week 6</title>
        <description>Blood was collected from participants at 6 weeks after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants' concentrations at the timepoint was calculated, along with the 95% CI.</description>
        <time_frame>6 weeks post vaccination</time_frame>
        <population>All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>Adacel® Tdap Vaccine</title>
            <description>Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose</description>
          </group>
        </group_list>
        <measure>
          <title>ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Week 6</title>
          <description>Blood was collected from participants at 6 weeks after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants' concentrations at the timepoint was calculated, along with the 95% CI.</description>
          <population>All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.</population>
          <units>EU/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.5" lower_limit="28.5" upper_limit="49.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FHA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="126.1" lower_limit="106.5" upper_limit="149.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PRN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="496.8" lower_limit="355.6" upper_limit="694.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FIM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="905.1" lower_limit="663.2" upper_limit="1235.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 6</title>
        <description>Blood was collected from participants at 6 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants' concentrations at the timepoint was calculated, along with the 95% CI.</description>
        <time_frame>6 months post vaccination</time_frame>
        <population>All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>Adacel® Tdap Vaccine</title>
            <description>Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose</description>
          </group>
        </group_list>
        <measure>
          <title>ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 6</title>
          <description>Blood was collected from participants at 6 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants' concentrations at the timepoint was calculated, along with the 95% CI.</description>
          <population>All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.</population>
          <units>EU/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.2" lower_limit="15.0" upper_limit="24.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FHA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.4" lower_limit="53.3" upper_limit="73.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PRN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="212.3" lower_limit="149.9" upper_limit="300.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FIM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="492.8" lower_limit="358.4" upper_limit="677.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 12</title>
        <description>Blood was collected from participants at 12 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants' concentrations at the timepoint was calculated, along with the 95% CI.</description>
        <time_frame>12 months post vaccination</time_frame>
        <population>All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>Adacel® Tdap Vaccine</title>
            <description>Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose</description>
          </group>
        </group_list>
        <measure>
          <title>ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 12</title>
          <description>Blood was collected from participants at 12 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants' concentrations at the timepoint was calculated, along with the 95% CI.</description>
          <population>All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.</population>
          <units>EU/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.1" lower_limit="11.6" upper_limit="19.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FHA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.2" lower_limit="39.0" upper_limit="54.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PRN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="141.1" lower_limit="103.4" upper_limit="192.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FIM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="368.7" lower_limit="264.2" upper_limit="514.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 18</title>
        <description>Blood was collected from participants at 18 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants' concentrations at the timepoint was calculated, along with the 95% CI.</description>
        <time_frame>18 months post vaccination</time_frame>
        <population>All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>Adacel® Tdap Vaccine</title>
            <description>Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose</description>
          </group>
        </group_list>
        <measure>
          <title>ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 18</title>
          <description>Blood was collected from participants at 18 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants' concentrations at the timepoint was calculated, along with the 95% CI.</description>
          <population>All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.</population>
          <units>EU/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.1" lower_limit="12.0" upper_limit="19.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FHA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.6" lower_limit="35.4" upper_limit="56.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PRN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="121.1" lower_limit="84.0" upper_limit="174.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FIM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="330.7" lower_limit="234.6" upper_limit="466.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 24</title>
        <description>Blood was collected from participants at 24 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants' concentrations at the timepoint was calculated, along with the 95% CI.</description>
        <time_frame>24 months post vaccination</time_frame>
        <population>All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>Adacel® Tdap Vaccine</title>
            <description>Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose</description>
          </group>
        </group_list>
        <measure>
          <title>ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 24</title>
          <description>Blood was collected from participants at 24 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants' concentrations at the timepoint was calculated, along with the 95% CI.</description>
          <population>All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.</population>
          <units>EU/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.8" lower_limit="7.9" upper_limit="14.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FHA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.0" lower_limit="30.1" upper_limit="50.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PRN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="114.1" lower_limit="74.9" upper_limit="173.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FIM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="298.0" lower_limit="187.3" upper_limit="474.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Week 2</title>
        <description>Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 2 weeks after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.</description>
        <time_frame>Prior to and 2 weeks after vaccination</time_frame>
        <population>All participants with blood collected and results reported at both timepoints are included in the analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>Adacel® Tdap Vaccine</title>
            <description>Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose</description>
          </group>
        </group_list>
        <measure>
          <title>Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Week 2</title>
          <description>Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 2 weeks after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.</description>
          <population>All participants with blood collected and results reported at both timepoints are included in the analysis population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FHA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PRN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FIM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Week 6</title>
        <description>Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 6 weeks after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.</description>
        <time_frame>Prior to and 6 weeks after vaccination</time_frame>
        <population>All participants with blood collected and results reported at both timepoints are included in the analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>Adacel® Tdap Vaccine</title>
            <description>Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose</description>
          </group>
        </group_list>
        <measure>
          <title>Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Week 6</title>
          <description>Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 6 weeks after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.</description>
          <population>All participants with blood collected and results reported at both timepoints are included in the analysis population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FHA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PRN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FIM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 6</title>
        <description>Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 6 months after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.</description>
        <time_frame>Prior to and 6 months after vaccination</time_frame>
        <population>All participants with blood collected and results reported at both timepoints are included in the analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>Adacel® Tdap Vaccine</title>
            <description>Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose</description>
          </group>
        </group_list>
        <measure>
          <title>Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 6</title>
          <description>Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 6 months after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.</description>
          <population>All participants with blood collected and results reported at both timepoints are included in the analysis population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FHA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PRN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FIM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 12</title>
        <description>Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 12 months after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.</description>
        <time_frame>Prior to and 12 months after vaccination</time_frame>
        <population>All participants with blood collected and results reported at both timepoints are included in the analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>Adacel® Tdap Vaccine</title>
            <description>Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose</description>
          </group>
        </group_list>
        <measure>
          <title>Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 12</title>
          <description>Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 12 months after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.</description>
          <population>All participants with blood collected and results reported at both timepoints are included in the analysis population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FHA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PRN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FIM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 18</title>
        <description>Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 18 months after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.</description>
        <time_frame>Prior to and 18 months after vaccination</time_frame>
        <population>All participants with blood collected and results reported at both timepoints are included in the analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>Adacel® Tdap Vaccine</title>
            <description>Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose</description>
          </group>
        </group_list>
        <measure>
          <title>Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 18</title>
          <description>Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 18 months after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.</description>
          <population>All participants with blood collected and results reported at both timepoints are included in the analysis population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FHA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PRN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FIM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 24</title>
        <description>Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 24 months after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.</description>
        <time_frame>Prior to and 24 months after vaccination</time_frame>
        <population>All participants with blood collected and results reported at both timepoints are included in the analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>Adacel® Tdap Vaccine</title>
            <description>Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose</description>
          </group>
        </group_list>
        <measure>
          <title>Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 24</title>
          <description>Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 24 months after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.</description>
          <population>All participants with blood collected and results reported at both timepoints are included in the analysis population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FHA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PRN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FIM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Kinetics of the ELISA IgG Antibody Rise in Serum</title>
        <description>The assessment of the kinetics of the ELISA IgG antibody rise in serum was defined by the protocol as the geometric mean fold rise at each timepoint (reported separately above). No additional analysis was pre-defined or performed for this outcome measure.</description>
        <time_frame>Prior to and following Tdap, through 24 months post-vaccination</time_frame>
        <population>No analysis was conducted for this outcome measure. See previous outcome measures for geometric mean fold rises at each timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Adacel® Tdap Vaccine</title>
            <description>Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose</description>
          </group>
        </group_list>
        <measure>
          <title>Kinetics of the ELISA IgG Antibody Rise in Serum</title>
          <description>The assessment of the kinetics of the ELISA IgG antibody rise in serum was defined by the protocol as the geometric mean fold rise at each timepoint (reported separately above). No additional analysis was pre-defined or performed for this outcome measure.</description>
          <population>No analysis was conducted for this outcome measure. See previous outcome measures for geometric mean fold rises at each timepoint.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>ELISA GMC of Breast Milk IgA to Pertussis Toxin (PT) at Baseline.</title>
        <description>Breast milk (colostrum) was collected from participants at baseline prior to vaccination for assessment of secretory IgA (sIgA) to the PT antigen by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL along with the 95% confidence interval. The lower limit of quantitation (LLOQ) of the assay was 10. Results of &lt;10 were reported as half the LLOQ (5).</description>
        <time_frame>Baseline (prior to vaccination)</time_frame>
        <population>All participants providing a breast milk (colostrum) sample at the timepoint are included in the analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>Adacel® Tdap Vaccine</title>
            <description>Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose</description>
          </group>
        </group_list>
        <measure>
          <title>ELISA GMC of Breast Milk IgA to Pertussis Toxin (PT) at Baseline.</title>
          <description>Breast milk (colostrum) was collected from participants at baseline prior to vaccination for assessment of secretory IgA (sIgA) to the PT antigen by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL along with the 95% confidence interval. The lower limit of quantitation (LLOQ) of the assay was 10. Results of &lt;10 were reported as half the LLOQ (5).</description>
          <population>All participants providing a breast milk (colostrum) sample at the timepoint are included in the analysis population.</population>
          <units>EU/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.8" lower_limit="2.5" upper_limit="336.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>ELISA GMC of Breast Milk IgA to PT at Week 2</title>
        <description>Breast milk was collected from participants at 2 weeks after vaccination for assessment of secretory IgA (sIgA) to PT and FHA by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL. Note that for the PT at this timepoint, all participants had a value of 5, the imputed value for below the LLOQ of the assay (&lt;10), and so the 95% CI is not reported, as there was no measurable variability in the data. The range is reported.</description>
        <time_frame>2 weeks post vaccination</time_frame>
        <population>All participants providing a breast milk sample at the timepoint are included in the analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>Adacel® Tdap Vaccine</title>
            <description>Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose</description>
          </group>
        </group_list>
        <measure>
          <title>ELISA GMC of Breast Milk IgA to PT at Week 2</title>
          <description>Breast milk was collected from participants at 2 weeks after vaccination for assessment of secretory IgA (sIgA) to PT and FHA by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL. Note that for the PT at this timepoint, all participants had a value of 5, the imputed value for below the LLOQ of the assay (&lt;10), and so the 95% CI is not reported, as there was no measurable variability in the data. The range is reported.</description>
          <population>All participants providing a breast milk sample at the timepoint are included in the analysis population.</population>
          <units>EU/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" lower_limit="5.0" upper_limit="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>ELISA GMC of Breast Milk IgA to PT at Week 6</title>
        <description>Breast milk was collected from participants at 6 weeks after vaccination for assessment of secretory IgA (sIgA) to PT and FHA by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL. Note that for the PT at this timepoint, all participants had a value of 5, the imputed value for below the LLOQ of the assay (&lt;10), and so the 95% CI is not reported, as there was no measurable variability in the data. The range is reported.</description>
        <time_frame>6 weeks post vaccination</time_frame>
        <population>All participants providing a breast milk sample at the timepoint are included in the analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>Adacel® Tdap Vaccine</title>
            <description>Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose</description>
          </group>
        </group_list>
        <measure>
          <title>ELISA GMC of Breast Milk IgA to PT at Week 6</title>
          <description>Breast milk was collected from participants at 6 weeks after vaccination for assessment of secretory IgA (sIgA) to PT and FHA by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL. Note that for the PT at this timepoint, all participants had a value of 5, the imputed value for below the LLOQ of the assay (&lt;10), and so the 95% CI is not reported, as there was no measurable variability in the data. The range is reported.</description>
          <population>All participants providing a breast milk sample at the timepoint are included in the analysis population.</population>
          <units>EU/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" lower_limit="5.0" upper_limit="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>ELISA GMC of Breast Milk IgA to PT at Month 6</title>
        <description>Breast milk was collected from participants at 6 weeks after vaccination for assessment of secretory IgA (sIgA) to PT and FHA by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL. Note that for the PT at this timepoint, all participants had a value of 5, the imputed value for below the LLOQ of the assay (&lt;10), and so the 95% CI is not reported, as there was no measurable variability in the data. The range is reported.</description>
        <time_frame>6 months post vaccination</time_frame>
        <population>All participants providing a breast milk sample at the timepoint are included in the analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>Adacel® Tdap Vaccine</title>
            <description>Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose</description>
          </group>
        </group_list>
        <measure>
          <title>ELISA GMC of Breast Milk IgA to PT at Month 6</title>
          <description>Breast milk was collected from participants at 6 weeks after vaccination for assessment of secretory IgA (sIgA) to PT and FHA by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL. Note that for the PT at this timepoint, all participants had a value of 5, the imputed value for below the LLOQ of the assay (&lt;10), and so the 95% CI is not reported, as there was no measurable variability in the data. The range is reported.</description>
          <population>All participants providing a breast milk sample at the timepoint are included in the analysis population.</population>
          <units>EU/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" lower_limit="5.0" upper_limit="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>ELISA GMC of Breast Milk IgA to FHA at Baseline.</title>
        <description>Breast milk (colostrum) was collected from participants at baseline prior to vaccination for assessment of secretory IgA (sIgA) to the FHA antigen by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL along with the 95% confidence interval.</description>
        <time_frame>Baseline (prior to vaccination)</time_frame>
        <population>All participants providing a breast milk (colostrum) sample at the timepoint are included in the analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>Adacel® Tdap Vaccine</title>
            <description>Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose</description>
          </group>
        </group_list>
        <measure>
          <title>ELISA GMC of Breast Milk IgA to FHA at Baseline.</title>
          <description>Breast milk (colostrum) was collected from participants at baseline prior to vaccination for assessment of secretory IgA (sIgA) to the FHA antigen by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL along with the 95% confidence interval.</description>
          <population>All participants providing a breast milk (colostrum) sample at the timepoint are included in the analysis population.</population>
          <units>EU/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.3" lower_limit="6.9" upper_limit="116.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>ELISA GMC of Breast Milk IgA to FHA at Week 2.</title>
        <description>Breast milk was collected from participants at 2 weeks post vaccination for assessment of secretory IgA (sIgA) to the FHA antigen by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL along with the 95% confidence interval.</description>
        <time_frame>2 weeks post vaccination</time_frame>
        <population>All participants providing a breast milk sample at the timepoint are included in the analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>Adacel® Tdap Vaccine</title>
            <description>Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose</description>
          </group>
        </group_list>
        <measure>
          <title>ELISA GMC of Breast Milk IgA to FHA at Week 2.</title>
          <description>Breast milk was collected from participants at 2 weeks post vaccination for assessment of secretory IgA (sIgA) to the FHA antigen by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL along with the 95% confidence interval.</description>
          <population>All participants providing a breast milk sample at the timepoint are included in the analysis population.</population>
          <units>EU/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.4" lower_limit="4.8" upper_limit="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>ELISA GMC of Breast Milk IgA to FHA at Week 6.</title>
        <description>Breast milk was collected from participants at 6 weeks post vaccination for assessment of secretory IgA (sIgA) to the FHA antigen by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL. Note that for the FHA at this timepoint, all participants had a concentration of 5, the imputed value for below the LLOQ of the assay (&lt;10), and so the 95% CI is not reported, as there was no measurable variability in the data. The range is reported.</description>
        <time_frame>6 weeks post vaccination</time_frame>
        <population>All participants providing a breast milk sample at the timepoint are included in the analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>Adacel® Tdap Vaccine</title>
            <description>Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose</description>
          </group>
        </group_list>
        <measure>
          <title>ELISA GMC of Breast Milk IgA to FHA at Week 6.</title>
          <description>Breast milk was collected from participants at 6 weeks post vaccination for assessment of secretory IgA (sIgA) to the FHA antigen by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL. Note that for the FHA at this timepoint, all participants had a concentration of 5, the imputed value for below the LLOQ of the assay (&lt;10), and so the 95% CI is not reported, as there was no measurable variability in the data. The range is reported.</description>
          <population>All participants providing a breast milk sample at the timepoint are included in the analysis population.</population>
          <units>EU/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" lower_limit="5.0" upper_limit="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>ELISA GMC of Breast Milk IgA to FHA at Month 6.</title>
        <description>Breast milk was collected from participants at 6 months post vaccination for assessment of secretory IgA (sIgA) to the FHA antigen by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL along with the 95% confidence interval.</description>
        <time_frame>6 months post vaccination</time_frame>
        <population>All participants providing a breast milk sample at the timepoint are included in the analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>Adacel® Tdap Vaccine</title>
            <description>Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose</description>
          </group>
        </group_list>
        <measure>
          <title>ELISA GMC of Breast Milk IgA to FHA at Month 6.</title>
          <description>Breast milk was collected from participants at 6 months post vaccination for assessment of secretory IgA (sIgA) to the FHA antigen by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL along with the 95% confidence interval.</description>
          <population>All participants providing a breast milk sample at the timepoint are included in the analysis population.</population>
          <units>EU/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.2" lower_limit="4.8" upper_limit="5.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>ELISA GMC of Breast Milk IgA to PRN and FIM by Study Day.</title>
        <description>Breast milk (colostrum) was collected from participants at baseline prior to vaccination for assessment of secretory IgA (sIgA) to the PRN and FIM antigen by ELISA. Available data at the timepoint were to be summarized by geometric mean of the concentration as reported in EU/mL along with the 95% confidence interval. The lower limit of quantitation (LLOQ) of the assay was 10 EU/mL.</description>
        <time_frame>Baseline (prior to vaccination), Week 2, Week 6 and Month 6 post vaccination</time_frame>
        <population>The laboratory staff was not successful in attempts to conduct the ELISA assay against the pertactin and fimbrae antigens with the breast milk samples.</population>
        <group_list>
          <group group_id="O1">
            <title>Adacel® Tdap Vaccine</title>
            <description>Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose</description>
          </group>
        </group_list>
        <measure>
          <title>ELISA GMC of Breast Milk IgA to PRN and FIM by Study Day.</title>
          <description>Breast milk (colostrum) was collected from participants at baseline prior to vaccination for assessment of secretory IgA (sIgA) to the PRN and FIM antigen by ELISA. Available data at the timepoint were to be summarized by geometric mean of the concentration as reported in EU/mL along with the 95% confidence interval. The lower limit of quantitation (LLOQ) of the assay was 10 EU/mL.</description>
          <population>The laboratory staff was not successful in attempts to conduct the ELISA assay against the pertactin and fimbrae antigens with the breast milk samples.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants With 4-fold Rise in Antibody in Breast Milk by Study Day.</title>
        <description>Breast milk samples were collected from participants for evaluation of PT and FHA secretory IgA (sIgA) by ELISA. The lower limit of quantification (LLOQ) for the assay was 10 EU/mL. A 4-fold rise in concentration from prior to vaccination was defined as a post-vaccination sIgA concentration greater than or equal to 40 EU/mL for participants with baseline sIgA concentrations less than the LLOQ, or 4 times the baseline sIgA concentration for baseline sIgA concentrations greater than the LLOQ.</description>
        <time_frame>Prior to vaccination, 2 weeks, 6 weeks, and 6 months after vaccination</time_frame>
        <population>Only 4 participants were able to provide a breast milk (colostrum) sample at baseline and post vaccination samples had no detectable titer, resulting in a fold-rise analysis being uninterpretable; therefore, this analysis was not conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Adacel® Tdap Vaccine</title>
            <description>Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants With 4-fold Rise in Antibody in Breast Milk by Study Day.</title>
          <description>Breast milk samples were collected from participants for evaluation of PT and FHA secretory IgA (sIgA) by ELISA. The lower limit of quantification (LLOQ) for the assay was 10 EU/mL. A 4-fold rise in concentration from prior to vaccination was defined as a post-vaccination sIgA concentration greater than or equal to 40 EU/mL for participants with baseline sIgA concentrations less than the LLOQ, or 4 times the baseline sIgA concentration for baseline sIgA concentrations greater than the LLOQ.</description>
          <population>Only 4 participants were able to provide a breast milk (colostrum) sample at baseline and post vaccination samples had no detectable titer, resulting in a fold-rise analysis being uninterpretable; therefore, this analysis was not conducted.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Fold Rise in Antibody Concentrations Assessed by ELISA in Breast Milk by Study Day</title>
        <description>Breast milk samples were collected from participants for evaluation of secretory IgA (sIgA) by ELISA. Geometric mean fold rise was defined as the geometric mean of participants' fold rise in post vaccination sIgA relative to the pre-vaccination sIgA.</description>
        <time_frame>Prior to vaccination, 2 weeks, 6 weeks, and 6 months after vaccination</time_frame>
        <population>Only 4 participants were able to provide a breast milk (colostrum) sample at baseline and post vaccination samples had no detectable titer, resulting in a fold-rise analysis being uninterpretable; therefore, this analysis was not conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Adacel® Tdap Vaccine</title>
            <description>Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Fold Rise in Antibody Concentrations Assessed by ELISA in Breast Milk by Study Day</title>
          <description>Breast milk samples were collected from participants for evaluation of secretory IgA (sIgA) by ELISA. Geometric mean fold rise was defined as the geometric mean of participants' fold rise in post vaccination sIgA relative to the pre-vaccination sIgA.</description>
          <population>Only 4 participants were able to provide a breast milk (colostrum) sample at baseline and post vaccination samples had no detectable titer, resulting in a fold-rise analysis being uninterpretable; therefore, this analysis was not conducted.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Kinetics of the ELISA IgG Antibody Decline in Breast Milk Expressed in EU/ml.</title>
        <description>Breast milk samples were collected from participants for evaluation of PT and FHA secretory IgA (sIgA) by ELISA. The protocol defined kinetics as assessment at each post-vaccination timepoint of the geometric mean fold rise, defined as the geometric mean of participants' fold rise in post vaccination sIgA relative to the pre-vaccination sIgA.</description>
        <time_frame>Prior to vaccination, 2 weeks, 6 weeks, and 6 months after vaccination</time_frame>
        <population>Only 4 participants were able to provide a breast milk (colostrum) sample at baseline and post vaccination samples had no detectable titer, resulting in a fold-rise analysis being uninterpretable; therefore, this analysis was not conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Adacel® Tdap Vaccine</title>
            <description>Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose</description>
          </group>
        </group_list>
        <measure>
          <title>Kinetics of the ELISA IgG Antibody Decline in Breast Milk Expressed in EU/ml.</title>
          <description>Breast milk samples were collected from participants for evaluation of PT and FHA secretory IgA (sIgA) by ELISA. The protocol defined kinetics as assessment at each post-vaccination timepoint of the geometric mean fold rise, defined as the geometric mean of participants' fold rise in post vaccination sIgA relative to the pre-vaccination sIgA.</description>
          <population>Only 4 participants were able to provide a breast milk (colostrum) sample at baseline and post vaccination samples had no detectable titer, resulting in a fold-rise analysis being uninterpretable; therefore, this analysis was not conducted.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Since pertussis vaccine is offered as standard of care to healthy adults, including postpartum women, anticipated AEs related to pertussis vaccine administration, as per Package Insert, were not collected. AEs reported for this protocol were limited to 1. severe vaso-vagal reaction, including loss of consciousness or &gt; grade 2 hypotension, associated with the blood draw; and 2. adverse events leading to infection or inability to breast feed following the use of the breast pump.</time_frame>
      <desc>Anticipated adverse events related to administration of the pertussis vaccine as per Package Insert include injection site reactions (pain, swelling and erythema) and systemic reactions (headache body ache and muscle weakness). Events meeting VAERS reporting requirements were to be reported to VAERS and not collected for this protocol.</desc>
      <group_list>
        <group group_id="E1">
          <title>Adacel® Tdap Vaccine</title>
          <description>Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Kathryn M. Edwards, MD</name_or_title>
      <organization>Vanderbilt Medical Center</organization>
      <phone>615-322-3078</phone>
      <email>Kathryn.edwards@vanderbilt.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01711645
org study id: 11-0035
secondary id: HHSN272201300023I
nct id: NCT01711645
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Monitoring immune response and longevity in serum and milk after Tdap administration to
      postpartum women. The clinical trial will involve women (aged 18 - 45 years) who have just
      delivered full-term infants (greater than or equal to 37 completed weeks of gestation) at
      Vanderbilt University Medical Center. The enrollment period will be fifteen months. The
      duration is over two years of observation.
This is a single site, prospective study involving only one intervention, receipt of a single
      0.5 mL intramuscular (IM) dose of Adacel (Tetanus toxoid, reduced diphtheria toxoid and
      acellular Pertussis) vaccine, among 55 healthy post partum women. The purpose of the study is
      to examine the immune responses and subsequent decline in serum and breast milk antibody
      titers over two years of observation. The clinical trial will involve women (aged 18 - 45
      years) who have just delivered full-term infants (greater than or equal to 37 completed weeks
      of gestation) at Vanderbilt University Medical Center. One particular population at
      Vanderbilt to target will be the "centering prenatal care group" that has breastfeeding rates
      as high as 75 percent at hospital discharge and maintained at 20 percent at 6 months. The
      enrollment period will be fifteen months. The subjects, staff assessing subjects, and
      laboratory personnel will be aware of receipt of the vaccine. Since only a single vaccine
      product is being utilized, there is no blinding needed of the subjects or staff.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
measure: Geometric Mean Fold Rise in Serum Immunoglobulin G (IgG) by ELISA at Week 2
time frame: Prior to and 2 weeks following vaccination
description: Blood was collected from participants at baseline prior to vaccination and at 2 weeks after vaccination for assessment of IgG by ELISA against the pertussis toxin (PT), filamentous hemaggluttinin (FHA), pertactin (PRN) and fimbrae (FIM) antigens. Antibody concentrations were reported as ELISA units per milliliter (EU/mL). The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% confidence interval (CI).
measure: Geometric Mean Fold Rise in Serum IgG by ELISA at Week 6
time frame: Prior to and 6 weeks following vaccination
description: Blood was collected from participants at baseline prior to vaccination and at 6 weeks after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% CI.
measure: Geometric Mean Fold Rise in Serum IgG by ELISA at Month 6
time frame: Prior to and 6 months following vaccination
description: Blood was collected from participants at baseline prior to vaccination and at 6 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% CI.
measure: Geometric Mean Fold Rise in Serum IgG by ELISA at Month 12
time frame: Prior to and 12 months following vaccination
description: Blood was collected from participants at baseline prior to vaccination and at 12 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% CI.
measure: Geometric Mean Fold Rise in Serum IgG by ELISA at Month 18
time frame: Prior to and 18 months following vaccination
description: Blood was collected from participants at baseline prior to vaccination and at 18 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% CI.
measure: Geometric Mean Fold Rise in Serum IgG by ELISA at Month 24
time frame: Prior to and 24 months following vaccination
description: Blood was collected from participants at baseline prior to vaccination and at 24 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% CI.
measure: ELISA Geometric Mean Concentrations (GMC) of Serum IgG to PT, FHA, PRN and FIM at Baseline
time frame: Baseline (prior to vaccination)
description: Blood was collected from participants at baseline prior to vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. Antibody concentrations were reported as ELISA units per milliliter (EU/mL). A value of 5 EU/mL was imputed for results reported as below the lower limit of quantitation (LLOQ) (<10 EU/mL). The geometric mean of participants' concentrations at the timepoint was calculated, along with the 95% CI.
measure: ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Week 2
time frame: 2 weeks post vaccination
description: Blood was collected from participants at 2 weeks after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants' concentrations at the timepoint was calculated, along with the 95% CI.
measure: ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Week 6
time frame: 6 weeks post vaccination
description: Blood was collected from participants at 6 weeks after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants' concentrations at the timepoint was calculated, along with the 95% CI.
measure: ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 6
time frame: 6 months post vaccination
description: Blood was collected from participants at 6 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants' concentrations at the timepoint was calculated, along with the 95% CI.
measure: ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 12
time frame: 12 months post vaccination
description: Blood was collected from participants at 12 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants' concentrations at the timepoint was calculated, along with the 95% CI.
measure: ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 18
time frame: 18 months post vaccination
description: Blood was collected from participants at 18 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants' concentrations at the timepoint was calculated, along with the 95% CI.
measure: ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 24
time frame: 24 months post vaccination
description: Blood was collected from participants at 24 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants' concentrations at the timepoint was calculated, along with the 95% CI.
measure: Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Week 2
time frame: Prior to and 2 weeks after vaccination
description: Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 2 weeks after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.
measure: Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Week 6
time frame: Prior to and 6 weeks after vaccination
description: Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 6 weeks after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.
measure: Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 6
time frame: Prior to and 6 months after vaccination
description: Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 6 months after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.
measure: Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 12
time frame: Prior to and 12 months after vaccination
description: Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 12 months after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.
measure: Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 18
time frame: Prior to and 18 months after vaccination
description: Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 18 months after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.
measure: Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 24
time frame: Prior to and 24 months after vaccination
description: Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 24 months after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.
measure: Kinetics of the ELISA IgG Antibody Rise in Serum
time frame: Prior to and following Tdap, through 24 months post-vaccination
description: The assessment of the kinetics of the ELISA IgG antibody rise in serum was defined by the protocol as the geometric mean fold rise at each timepoint (reported separately above). No additional analysis was pre-defined or performed for this outcome measure.
measure: ELISA GMC of Breast Milk IgA to Pertussis Toxin (PT) at Baseline.
time frame: Baseline (prior to vaccination)
description: Breast milk (colostrum) was collected from participants at baseline prior to vaccination for assessment of secretory IgA (sIgA) to the PT antigen by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL along with the 95% confidence interval. The lower limit of quantitation (LLOQ) of the assay was 10. Results of <10 were reported as half the LLOQ (5).
measure: ELISA GMC of Breast Milk IgA to PT at Week 2
time frame: 2 weeks post vaccination
description: Breast milk was collected from participants at 2 weeks after vaccination for assessment of secretory IgA (sIgA) to PT and FHA by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL. Note that for the PT at this timepoint, all participants had a value of 5, the imputed value for below the LLOQ of the assay (<10), and so the 95% CI is not reported, as there was no measurable variability in the data. The range is reported.
measure: ELISA GMC of Breast Milk IgA to PT at Week 6
time frame: 6 weeks post vaccination
description: Breast milk was collected from participants at 6 weeks after vaccination for assessment of secretory IgA (sIgA) to PT and FHA by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL. Note that for the PT at this timepoint, all participants had a value of 5, the imputed value for below the LLOQ of the assay (<10), and so the 95% CI is not reported, as there was no measurable variability in the data. The range is reported.
measure: ELISA GMC of Breast Milk IgA to PT at Month 6
time frame: 6 months post vaccination
description: Breast milk was collected from participants at 6 weeks after vaccination for assessment of secretory IgA (sIgA) to PT and FHA by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL. Note that for the PT at this timepoint, all participants had a value of 5, the imputed value for below the LLOQ of the assay (<10), and so the 95% CI is not reported, as there was no measurable variability in the data. The range is reported.
measure: ELISA GMC of Breast Milk IgA to FHA at Baseline.
time frame: Baseline (prior to vaccination)
description: Breast milk (colostrum) was collected from participants at baseline prior to vaccination for assessment of secretory IgA (sIgA) to the FHA antigen by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL along with the 95% confidence interval.
measure: ELISA GMC of Breast Milk IgA to FHA at Week 2.
time frame: 2 weeks post vaccination
description: Breast milk was collected from participants at 2 weeks post vaccination for assessment of secretory IgA (sIgA) to the FHA antigen by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL along with the 95% confidence interval.
measure: ELISA GMC of Breast Milk IgA to FHA at Week 6.
time frame: 6 weeks post vaccination
description: Breast milk was collected from participants at 6 weeks post vaccination for assessment of secretory IgA (sIgA) to the FHA antigen by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL. Note that for the FHA at this timepoint, all participants had a concentration of 5, the imputed value for below the LLOQ of the assay (<10), and so the 95% CI is not reported, as there was no measurable variability in the data. The range is reported.
measure: ELISA GMC of Breast Milk IgA to FHA at Month 6.
time frame: 6 months post vaccination
description: Breast milk was collected from participants at 6 months post vaccination for assessment of secretory IgA (sIgA) to the FHA antigen by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL along with the 95% confidence interval.
measure: ELISA GMC of Breast Milk IgA to PRN and FIM by Study Day.
time frame: Baseline (prior to vaccination), Week 2, Week 6 and Month 6 post vaccination
description: Breast milk (colostrum) was collected from participants at baseline prior to vaccination for assessment of secretory IgA (sIgA) to the PRN and FIM antigen by ELISA. Available data at the timepoint were to be summarized by geometric mean of the concentration as reported in EU/mL along with the 95% confidence interval. The lower limit of quantitation (LLOQ) of the assay was 10 EU/mL.
measure: Proportion of Participants With 4-fold Rise in Antibody in Breast Milk by Study Day.
time frame: Prior to vaccination, 2 weeks, 6 weeks, and 6 months after vaccination
description: Breast milk samples were collected from participants for evaluation of PT and FHA secretory IgA (sIgA) by ELISA. The lower limit of quantification (LLOQ) for the assay was 10 EU/mL. A 4-fold rise in concentration from prior to vaccination was defined as a post-vaccination sIgA concentration greater than or equal to 40 EU/mL for participants with baseline sIgA concentrations less than the LLOQ, or 4 times the baseline sIgA concentration for baseline sIgA concentrations greater than the LLOQ.
measure: Geometric Mean Fold Rise in Antibody Concentrations Assessed by ELISA in Breast Milk by Study Day
time frame: Prior to vaccination, 2 weeks, 6 weeks, and 6 months after vaccination
description: Breast milk samples were collected from participants for evaluation of secretory IgA (sIgA) by ELISA. Geometric mean fold rise was defined as the geometric mean of participants' fold rise in post vaccination sIgA relative to the pre-vaccination sIgA.
measure: Kinetics of the ELISA IgG Antibody Decline in Breast Milk Expressed in EU/ml.
time frame: Prior to vaccination, 2 weeks, 6 weeks, and 6 months after vaccination
description: Breast milk samples were collected from participants for evaluation of PT and FHA secretory IgA (sIgA) by ELISA. The protocol defined kinetics as assessment at each post-vaccination timepoint of the geometric mean fold rise, defined as the geometric mean of participants' fold rise in post vaccination sIgA relative to the pre-vaccination sIgA.
arm group label: Adacel® Tdap vaccine
arm group type: Experimental
description: 55 postpartum subjects receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed).
intervention type: Biological
intervention name: Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed onto aluminum phosphate
description: 55 postpartum subjects receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed).
arm group label: Adacel® Tdap vaccine
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Whooping Cough
mesh term: Tetanus
mesh term: Diphtheria
mesh term: Aluminum phosphate
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 