<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/NCT01689324</url>
  </required_header>
  <id_info>
    <org_study_id>Td540</org_study_id>
    <secondary_id>U1111-1124-7671</secondary_id>
    <nct_id>NCT01689324</nct_id>
  </id_info>
  <brief_title>Study of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine (ADACEL®) as a Booster in Adolescents</brief_title>
  <official_title>Immunogenicity and Safety of the Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (SP306) as a Booster in Japanese Adolescents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sanofi Pasteur, a Sanofi Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sanofi</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to assess the immunogenicity and safety of tetanus toxoid, reduced&#xD;
      diphtheria toxoid and acellular pertussis vaccine (ADACEL®, Tdap vaccine) as a booster dose&#xD;
      in adolescents in Japan.&#xD;
&#xD;
      Primary Objective:&#xD;
&#xD;
        -  To assess the immunogenicity of Tdap (SP306) when administered as a single dose in&#xD;
           Japanese adolescents&#xD;
&#xD;
      Secondary Objective:&#xD;
&#xD;
        -  To assess the safety of Tdap vaccine when administered as a single dose in Japanese&#xD;
           adolescents.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All participants will receive a single booster dose of Tdap vaccine (ADACEL®) on Day 0 and&#xD;
      undergo immunogenicity assessment from blood samples provided prior to, and 28 days&#xD;
      post-vaccination. Tolerability and safety will be monitored up to 28 days post-vaccination.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">November 2012</primary_completion_date>
  <phase>Phase 1/Phase 2</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Following Vaccination With ADACEL®</measure>
    <time_frame>Day 28 post-vaccination</time_frame>
    <description>Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.1 IU/mL, post-vaccination.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Booster Response to Diphtheria and Tetanus Antigens Following Vaccination With ADACEL®</measure>
    <time_frame>Day 28 post-vaccination</time_frame>
    <description>Diphtheria booster response was defined as a ≥ 4-fold rise in pre- to post-vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.56 IU/mL; or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration &gt; 2.56 IU/mL.&#xD;
Tetanus booster response was defined as a ≥ 4-fold rise in pre- to post- vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.7 IU/mL; or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration &gt; 2.7 IU/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Booster Response to Pertussis Antigens, Pertussis Toxoid and Filamentous Hemagglutinin Following Vaccination With ADACEL®</measure>
    <time_frame>Day 28 post-vaccination</time_frame>
    <description>Booster responses were defined as: Pre-vaccination antibody concentrations less than the lower limit of quantitation (LLOQ) and a post-vaccination levels ≥ 4x LLOQ; or Pre-vaccination antibody concentrations ≥ LLOQ but &lt; 4x LLOQ, and a 4-fold rise (i.e., post-/pre-vaccination ≥ 4), or Pre-vaccination antibody concentrations ≥ 4x LLOQ and a 2-fold rise (i.e., post-/pre-vaccination ≥ 2)</description>
  </primary_outcome>
  <other_outcome>
    <measure>Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Pre-vaccination With ADACEL®</measure>
    <time_frame>Day 0 pre-vaccination</time_frame>
    <description>Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.1 IU/mL.</description>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Pre-vaccination and Post-vaccination With ADACEL®</measure>
    <time_frame>Day 0 (pre-vaccination) and day 28 post-vaccination</time_frame>
    <description>Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.01 IU/mL.</description>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Pre-vaccination and Post-vaccination With ADACEL®</measure>
    <time_frame>Day 0 (pre-vaccination) and day 28 post-vaccination</time_frame>
    <description>Seroprotection was defined as the percentage of participants with antibody concentration of ≥1.0 IU/mL.</description>
  </other_outcome>
  <other_outcome>
    <measure>Geometric Mean Concentrations With Respect to Diphtheria and Tetanus Antibodies Pre- and Post-vaccination With ADACEL®</measure>
    <time_frame>Day 0 (pre-vaccination) and Day 28 post-vaccination</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Geometric Mean Concentrations With Respect to Pertussis Antibodies Pre- and Post-vaccination With ADACEL®</measure>
    <time_frame>Day 0 (pre-vaccination) and Day 28 post-vaccination</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of Participants With Booster Response to Pertussis Antigens, Pertactin and Fimbriae Following Vaccination With ADACEL®</measure>
    <time_frame>Day 28 post-vaccination</time_frame>
    <description>Booster responses were defined as: Pre-vaccination antibody concentrations less than the lower limit of quantitation (LLOQ) and a post-vaccination levels ≥ 4x LLOQ; or Pre-vaccination antibody concentrations ≥ LLOQ but &lt; 4x LLOQ, and a 4-fold rise (i.e., post-/pre-vaccination ≥ 4), or Pre-vaccination antibody concentrations ≥ 4x LLOQ and a 2-fold rise (i.e., post-/pre-vaccination ≥ 2)</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With ADACEL®</measure>
    <time_frame>Day 0 up to Day 7 post-vaccination</time_frame>
    <description>Solicited injection-site reactions: Pain, Redness, and Swelling. Grade 3: Pain, Significant, prevents daily activity; Redness and Swelling, &gt;100 mm.&#xD;
Solicited systemic reactions: Fever (Temperature); Headache, Malaise, and Myalgia. Grade 3: Fever, ≥ 39°C; Headache, Malaise and Myalgia, Significant, prevents daily activity.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>Pertussis</condition>
  <condition>Tetanus</condition>
  <condition>Diphtheria</condition>
  <arm_group>
    <arm_group_label>Study Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a single booster dose of Tdap vaccine (ADACEL®) on Day 0.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>(ADACEL®): Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis</intervention_name>
    <description>0.5 mL, Intramuscular</description>
    <arm_group_label>Study Group</arm_group_label>
    <other_name>ADACEL®</other_name>
    <other_name>Tdap Vaccine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 11 or 12 years on the day of inclusion&#xD;
&#xD;
          -  Informed consent form and assent form signed and dated by the parent(s) / legal&#xD;
             representative and the subject respectively&#xD;
&#xD;
          -  Completed childhood vaccination against diphtheria, pertussis and tetanus (i.e,&#xD;
             received 4 doses of Japanese-produced tetanus toxoid, diphtheria toxoid and acellular&#xD;
             pertussis vaccine absorbed [DTaP vaccine]), confirmed by checking immunization records&#xD;
             and have not yet undergone additional adsorbed Diphtheria and Tetanus toxoid (DT)&#xD;
             vaccination&#xD;
&#xD;
          -  Able to attend all scheduled visits and to comply with all trial procedures&#xD;
&#xD;
          -  For female subjects, either pre-menarchal, or post-menarchal with a negative urine&#xD;
             pregnancy test.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any conditions or diseases which, in the opinion of the investigator&#xD;
&#xD;
          -  would pose a health risk to the subject&#xD;
&#xD;
          -  or might interfere with the ability to participate fully in the study&#xD;
&#xD;
          -  or might interfere with evaluation of the vaccine&#xD;
&#xD;
          -  or would otherwise make participation inappropriate according to the investigator's&#xD;
             clinical judgment&#xD;
&#xD;
          -  History of diphtheria, tetanus, pertussis, confirmed either clinically, serologically,&#xD;
             or microbiologically&#xD;
&#xD;
          -  Known systemic hypersensitivity to any of the vaccine components or history of a life&#xD;
             threatening reaction to a vaccine containing the same substances of the study vaccine&#xD;
&#xD;
          -  Vaccination in the last 5 years against tetanus, diphtheria, and/or pertussis&#xD;
&#xD;
          -  Known or suspected congenital immunodeficiency, or current / previous acquired&#xD;
             immunodeficiency, or current / previous receipt of immunosuppressive therapy such as&#xD;
             anti-cancer chemotherapy or radiation therapy, or current / previous (within the last&#xD;
             6 months) systemic corticosteroid therapy&#xD;
&#xD;
          -  Participation in another clinical trial investigating a vaccine, drug, medical device,&#xD;
             or medical procedure in the 4 weeks preceding the trial inclusion&#xD;
&#xD;
          -  Planned participation in another clinical trial during the present trial period&#xD;
&#xD;
          -  Receipt of blood or blood-derived products in the past 3 months, that might interfere&#xD;
             with assessment of the immune response&#xD;
&#xD;
          -  Receipt of any vaccine within the 4 weeks preceding the trial vaccination, except for&#xD;
             influenza vaccination, which may be received at least 2 weeks before the study vaccine&#xD;
&#xD;
          -  Planned receipt of any vaccine during the trial period&#xD;
&#xD;
          -  Clinical or known serological evidence of systemic illness including Hepatitis B,&#xD;
             Hepatitis C and/or Human Immunodeficiency Virus (HIV) infection&#xD;
&#xD;
          -  At high risk for diphtheria, tetanus or pertussis infection during the trial&#xD;
&#xD;
          -  Known pregnancy, or a positive urine pregnancy test&#xD;
&#xD;
          -  Currently breastfeeding a child&#xD;
&#xD;
          -  Known thrombocytopenia, contraindicating intramuscular (IM) vaccination, or a history&#xD;
             of thrombocytopenia&#xD;
&#xD;
          -  Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,&#xD;
             contraindicating IM vaccination&#xD;
&#xD;
          -  History of acute disseminated encephalomyelitis, encephalopathy, Guillain-Barré&#xD;
             Syndrome (GBS), or autoimmune disease&#xD;
&#xD;
          -  Deprived of freedom by an administrative or court order, or in an emergency setting,&#xD;
             or hospitalized involuntarily&#xD;
&#xD;
          -  Current alcohol abuse or drug addiction that might interfere with the ability to&#xD;
             comply with trial procedures&#xD;
&#xD;
          -  Identified as an employee of an Investigator, a study center, a study-affiliated&#xD;
             vendor, or the Sponsor, with direct or indirect involvement in the proposed study or&#xD;
             other studies under the direction of that Investigator or study center; or identified&#xD;
             as a spouse or child (whether natural or adopted) of such an employee.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Sanofi Pasteur K.K</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Aichi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ibaraki</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nagano</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <link>
    <url>http://www.sanofipasteur.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>February 2014</verification_date>
  <study_first_submitted>September 17, 2012</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <results_first_submitted>November 7, 2013</results_first_submitted>
  <results_first_submitted_qc>February 19, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">February 21, 2014</results_first_posted>
  <last_update_submitted>February 19, 2014</last_update_submitted>
  <last_update_submitted_qc>February 19, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 21, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pertussis</keyword>
  <keyword>Tetanus</keyword>
  <keyword>Diphtheria</keyword>
  <keyword>Acellular pertussis</keyword>
  <keyword>ADACEL®</keyword>
  <keyword>Tdap vaccine</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>
    <mesh_term>Tetany</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaccines</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study participants were enrolled from 12 September through 14 October 2012 in 3 clinic centers in Japan.</recruitment_details>
      <pre_assignment_details>A total of 43 participants that met all the inclusion criteria but none of the exclusion criteria were enrolled and vaccinated in the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Study Group</title>
          <description>Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Study Group</title>
          <description>Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="43"/>
          </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="43"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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="11.4" spread="0.5"/>
                  </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="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </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>Japan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Following Vaccination With ADACEL®</title>
        <description>Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.1 IU/mL, post-vaccination.</description>
        <time_frame>Day 28 post-vaccination</time_frame>
        <population>Seroprotection to diphtheria and tetanus antigens were determined in the Immunology Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>Study Group</title>
            <description>Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Following Vaccination With ADACEL®</title>
          <description>Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.1 IU/mL, post-vaccination.</description>
          <population>Seroprotection to diphtheria and tetanus antigens were determined in the Immunology Analysis Set</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Diphtheria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tetanus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Booster Response to Diphtheria and Tetanus Antigens Following Vaccination With ADACEL®</title>
        <description>Diphtheria booster response was defined as a ≥ 4-fold rise in pre- to post-vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.56 IU/mL; or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration &gt; 2.56 IU/mL.&#xD;
Tetanus booster response was defined as a ≥ 4-fold rise in pre- to post- vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.7 IU/mL; or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration &gt; 2.7 IU/mL.</description>
        <time_frame>Day 28 post-vaccination</time_frame>
        <population>Booster response to diphtheria and tetanus antigens were determined in the Immunology Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>Study Group</title>
            <description>Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Booster Response to Diphtheria and Tetanus Antigens Following Vaccination With ADACEL®</title>
          <description>Diphtheria booster response was defined as a ≥ 4-fold rise in pre- to post-vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.56 IU/mL; or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration &gt; 2.56 IU/mL.&#xD;
Tetanus booster response was defined as a ≥ 4-fold rise in pre- to post- vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.7 IU/mL; or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration &gt; 2.7 IU/mL.</description>
          <population>Booster response to diphtheria and tetanus antigens were determined in the Immunology Analysis Set</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Diphtheria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tetanus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Booster Response to Pertussis Antigens, Pertussis Toxoid and Filamentous Hemagglutinin Following Vaccination With ADACEL®</title>
        <description>Booster responses were defined as: Pre-vaccination antibody concentrations less than the lower limit of quantitation (LLOQ) and a post-vaccination levels ≥ 4x LLOQ; or Pre-vaccination antibody concentrations ≥ LLOQ but &lt; 4x LLOQ, and a 4-fold rise (i.e., post-/pre-vaccination ≥ 4), or Pre-vaccination antibody concentrations ≥ 4x LLOQ and a 2-fold rise (i.e., post-/pre-vaccination ≥ 2)</description>
        <time_frame>Day 28 post-vaccination</time_frame>
        <population>Booster response to pertussis antigens were determined in the Immunology Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>Study Group</title>
            <description>Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Booster Response to Pertussis Antigens, Pertussis Toxoid and Filamentous Hemagglutinin Following Vaccination With ADACEL®</title>
          <description>Booster responses were defined as: Pre-vaccination antibody concentrations less than the lower limit of quantitation (LLOQ) and a post-vaccination levels ≥ 4x LLOQ; or Pre-vaccination antibody concentrations ≥ LLOQ but &lt; 4x LLOQ, and a 4-fold rise (i.e., post-/pre-vaccination ≥ 4), or Pre-vaccination antibody concentrations ≥ 4x LLOQ and a 2-fold rise (i.e., post-/pre-vaccination ≥ 2)</description>
          <population>Booster response to pertussis antigens were determined in the Immunology Analysis Set</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pertussis toxoid</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Filamentous hemagglutinin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Pre-vaccination With ADACEL®</title>
        <description>Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.1 IU/mL.</description>
        <time_frame>Day 0 pre-vaccination</time_frame>
        <population>Pre-vaccination seroprotection to diphtheria and tetanus antigens were determined in the Immunology Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>Study Group</title>
            <description>Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Pre-vaccination With ADACEL®</title>
          <description>Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.1 IU/mL.</description>
          <population>Pre-vaccination seroprotection to diphtheria and tetanus antigens were determined in the Immunology Analysis Set</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Diphtheria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tetanus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Pre-vaccination and Post-vaccination With ADACEL®</title>
        <description>Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.01 IU/mL.</description>
        <time_frame>Day 0 (pre-vaccination) and day 28 post-vaccination</time_frame>
        <population>Pre- and post-vaccination seroprotection to diphtheria and tetanus antigens were determined in the Immunology Analysis Set.</population>
        <group_list>
          <group group_id="O1">
            <title>Study Group</title>
            <description>Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Pre-vaccination and Post-vaccination With ADACEL®</title>
          <description>Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.01 IU/mL.</description>
          <population>Pre- and post-vaccination seroprotection to diphtheria and tetanus antigens were determined in the Immunology Analysis Set.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Diphtheria (Pre-vaccination)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diphtheria (Post-vaccination)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tetanus (Pre-vaccination)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tetanus (Post-vaccination)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Pre-vaccination and Post-vaccination With ADACEL®</title>
        <description>Seroprotection was defined as the percentage of participants with antibody concentration of ≥1.0 IU/mL.</description>
        <time_frame>Day 0 (pre-vaccination) and day 28 post-vaccination</time_frame>
        <population>Pre- and post-vaccination seroprotection to diphtheria and tetanus antigens were determined in the Immunology Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>Study Group</title>
            <description>Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Pre-vaccination and Post-vaccination With ADACEL®</title>
          <description>Seroprotection was defined as the percentage of participants with antibody concentration of ≥1.0 IU/mL.</description>
          <population>Pre- and post-vaccination seroprotection to diphtheria and tetanus antigens were determined in the Immunology Analysis Set</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Diphtheria (Pre-vaccination)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diphtheria (Post-vaccination)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tetanus (Pre-vaccination)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tetanus (Post-vaccination)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Geometric Mean Concentrations With Respect to Diphtheria and Tetanus Antibodies Pre- and Post-vaccination With ADACEL®</title>
        <time_frame>Day 0 (pre-vaccination) and Day 28 post-vaccination</time_frame>
        <population>Pre and post vaccination geometric mean concentrations to Diphtheria and Tetanus antigens were determined in the Immunology Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>Study Group</title>
            <description>Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Concentrations With Respect to Diphtheria and Tetanus Antibodies Pre- and Post-vaccination With ADACEL®</title>
          <population>Pre and post vaccination geometric mean concentrations to Diphtheria and Tetanus antigens were determined in the Immunology Analysis Set</population>
          <units>Titers</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="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Diphtheria (Pre-vaccination)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.22" lower_limit="0.14" upper_limit="0.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diphtheria (Post-vaccination)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.58" lower_limit="6.76" upper_limit="10.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tetanus (Pre-vaccination)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.46" lower_limit="0.33" upper_limit="0.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tetanus (Post-vaccination)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.80" lower_limit="30.16" upper_limit="47.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Geometric Mean Concentrations With Respect to Pertussis Antibodies Pre- and Post-vaccination With ADACEL®</title>
        <time_frame>Day 0 (pre-vaccination) and Day 28 post-vaccination</time_frame>
        <population>Pre and post vaccination geometric mean concentrations to pertussis antibodies were determined in the Immunology Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>Study Group</title>
            <description>Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Concentrations With Respect to Pertussis Antibodies Pre- and Post-vaccination With ADACEL®</title>
          <population>Pre and post vaccination geometric mean concentrations to pertussis antibodies were determined in the Immunology Analysis Set</population>
          <units>Titers</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="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pertussis toxoid (pre-vaccination)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.21" lower_limit="7.82" upper_limit="19.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pertussis toxoid (post-vaccination)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.92" lower_limit="33.65" upper_limit="65.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Filamentous hemagglutinin (pre-vaccination)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.79" lower_limit="23.47" upper_limit="51.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Filamentous hemagglutinin (post-vaccination)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="204.00" lower_limit="164.26" upper_limit="253.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pertactin (pre-vaccination)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.64" lower_limit="6.28" upper_limit="18.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pertactin (post-vaccination)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="272.82" lower_limit="197.63" upper_limit="376.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fimbriae types 2 and 3 (pre-vaccination)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.78" lower_limit="5.42" upper_limit="11.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fimbriae types 2 and 3 (post-vaccination)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="748.28" lower_limit="443.23" upper_limit="1263.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Percentage of Participants With Booster Response to Pertussis Antigens, Pertactin and Fimbriae Following Vaccination With ADACEL®</title>
        <description>Booster responses were defined as: Pre-vaccination antibody concentrations less than the lower limit of quantitation (LLOQ) and a post-vaccination levels ≥ 4x LLOQ; or Pre-vaccination antibody concentrations ≥ LLOQ but &lt; 4x LLOQ, and a 4-fold rise (i.e., post-/pre-vaccination ≥ 4), or Pre-vaccination antibody concentrations ≥ 4x LLOQ and a 2-fold rise (i.e., post-/pre-vaccination ≥ 2)</description>
        <time_frame>Day 28 post-vaccination</time_frame>
        <population>Booster response to pertussis antigens were determined in the Immunology Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>Study Group</title>
            <description>Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Booster Response to Pertussis Antigens, Pertactin and Fimbriae Following Vaccination With ADACEL®</title>
          <description>Booster responses were defined as: Pre-vaccination antibody concentrations less than the lower limit of quantitation (LLOQ) and a post-vaccination levels ≥ 4x LLOQ; or Pre-vaccination antibody concentrations ≥ LLOQ but &lt; 4x LLOQ, and a 4-fold rise (i.e., post-/pre-vaccination ≥ 4), or Pre-vaccination antibody concentrations ≥ 4x LLOQ and a 2-fold rise (i.e., post-/pre-vaccination ≥ 2)</description>
          <population>Booster response to pertussis antigens were determined in the Immunology Analysis Set</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pertactin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fimbriae Types 2 and 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With ADACEL®</title>
        <description>Solicited injection-site reactions: Pain, Redness, and Swelling. Grade 3: Pain, Significant, prevents daily activity; Redness and Swelling, &gt;100 mm.&#xD;
Solicited systemic reactions: Fever (Temperature); Headache, Malaise, and Myalgia. Grade 3: Fever, ≥ 39°C; Headache, Malaise and Myalgia, Significant, prevents daily activity.</description>
        <time_frame>Day 0 up to Day 7 post-vaccination</time_frame>
        <population>Solicited injection site and systemic reactions were assessed in the Safety Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>Study Group</title>
            <description>Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With ADACEL®</title>
          <description>Solicited injection-site reactions: Pain, Redness, and Swelling. Grade 3: Pain, Significant, prevents daily activity; Redness and Swelling, &gt;100 mm.&#xD;
Solicited systemic reactions: Fever (Temperature); Headache, Malaise, and Myalgia. Grade 3: Fever, ≥ 39°C; Headache, Malaise and Myalgia, Significant, prevents daily activity.</description>
          <population>Solicited injection site and systemic reactions were assessed in the Safety Analysis Set</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Solicited injection site Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 solicited injection site Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Solicited injection site Erythema</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 solicited injection site Erythema</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Solicited injection site Swelling</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 solicited injection site Swelling</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Fever</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Headache</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Malaise</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Malaise</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Myalgia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data were collected from Day 0 (post-vaccination) up to 1 month post-vaccination</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Study Group</title>
          <description>Participants received a single booster dose of Tdap vaccine on Day 0.</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="43"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5.00</frequency_threshold>
        <default_vocab>MedDRA 15.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="39" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Solicited injection site Pain</sub_title>
                <counts group_id="E1" events="37" subjects_affected="37" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Solicited injection site Erythema</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Solicited injection site Swelling</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="17" subjects_affected="17" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" events="9" subjects_affected="7" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="43"/>
              </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>Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Director</name_or_title>
      <organization>Sanofi Pasteur Inc.</organization>
      <email>RegistryContactUs@sanofipasteur.com</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/NCT01689324
org study id: Td540
secondary id: U1111-1124-7671
nct id: NCT01689324
lead sponsor: 
has dmc: No
This study is designed to assess the immunogenicity and safety of tetanus toxoid, reduced
      diphtheria toxoid and acellular pertussis vaccine (ADACEL®, Tdap vaccine) as a booster dose
      in adolescents in Japan.

      Primary Objective:

        -  To assess the immunogenicity of Tdap (SP306) when administered as a single dose in
           Japanese adolescents

      Secondary Objective:

        -  To assess the safety of Tdap vaccine when administered as a single dose in Japanese
           adolescents.
All participants will receive a single booster dose of Tdap vaccine (ADACEL®) on Day 0 and
      undergo immunogenicity assessment from blood samples provided prior to, and 28 days
      post-vaccination. Tolerability and safety will be monitored up to 28 days post-vaccination.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Following Vaccination With ADACEL®
time frame: Day 28 post-vaccination
description: Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.1 IU/mL, post-vaccination.
measure: Percentage of Participants With Booster Response to Diphtheria and Tetanus Antigens Following Vaccination With ADACEL®
time frame: Day 28 post-vaccination
description: Diphtheria booster response was defined as a ≥ 4-fold rise in pre- to post-vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.56 IU/mL; or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration > 2.56 IU/mL.
Tetanus booster response was defined as a ≥ 4-fold rise in pre- to post- vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.7 IU/mL; or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration > 2.7 IU/mL.
measure: Percentage of Participants With Booster Response to Pertussis Antigens, Pertussis Toxoid and Filamentous Hemagglutinin Following Vaccination With ADACEL®
time frame: Day 28 post-vaccination
description: Booster responses were defined as: Pre-vaccination antibody concentrations less than the lower limit of quantitation (LLOQ) and a post-vaccination levels ≥ 4x LLOQ; or Pre-vaccination antibody concentrations ≥ LLOQ but < 4x LLOQ, and a 4-fold rise (i.e., post-/pre-vaccination ≥ 4), or Pre-vaccination antibody concentrations ≥ 4x LLOQ and a 2-fold rise (i.e., post-/pre-vaccination ≥ 2)
measure: Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Pre-vaccination With ADACEL®
time frame: Day 0 pre-vaccination
description: Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.1 IU/mL.
measure: Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Pre-vaccination and Post-vaccination With ADACEL®
time frame: Day 0 (pre-vaccination) and day 28 post-vaccination
description: Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.01 IU/mL.
measure: Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Pre-vaccination and Post-vaccination With ADACEL®
time frame: Day 0 (pre-vaccination) and day 28 post-vaccination
description: Seroprotection was defined as the percentage of participants with antibody concentration of ≥1.0 IU/mL.
measure: Geometric Mean Concentrations With Respect to Diphtheria and Tetanus Antibodies Pre- and Post-vaccination With ADACEL®
time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
measure: Geometric Mean Concentrations With Respect to Pertussis Antibodies Pre- and Post-vaccination With ADACEL®
time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
measure: Percentage of Participants With Booster Response to Pertussis Antigens, Pertactin and Fimbriae Following Vaccination With ADACEL®
time frame: Day 28 post-vaccination
description: Booster responses were defined as: Pre-vaccination antibody concentrations less than the lower limit of quantitation (LLOQ) and a post-vaccination levels ≥ 4x LLOQ; or Pre-vaccination antibody concentrations ≥ LLOQ but < 4x LLOQ, and a 4-fold rise (i.e., post-/pre-vaccination ≥ 4), or Pre-vaccination antibody concentrations ≥ 4x LLOQ and a 2-fold rise (i.e., post-/pre-vaccination ≥ 2)
measure: Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With ADACEL®
time frame: Day 0 up to Day 7 post-vaccination
description: Solicited injection-site reactions: Pain, Redness, and Swelling. Grade 3: Pain, Significant, prevents daily activity; Redness and Swelling, >100 mm.
Solicited systemic reactions: Fever (Temperature); Headache, Malaise, and Myalgia. Grade 3: Fever, ≥ 39°C; Headache, Malaise and Myalgia, Significant, prevents daily activity.
arm group label: Study Group
arm group type: Experimental
description: Participants will receive a single booster dose of Tdap vaccine (ADACEL®) on Day 0.
intervention type: Biological
intervention name: (ADACEL®): Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis
description: 0.5 mL, Intramuscular
arm group label: Study Group
other name: ADACEL®
other name: Tdap Vaccine
criteria: 
gender: All
minimum age: 11 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Medical Director
role: Study Director
affiliation: Sanofi Pasteur K.K
facility: 
facility: 
facility: 
country: Japan
url: http://www.sanofipasteur.com
description: Related Info
responsible party type: Sponsor
mesh term: Whooping Cough
mesh term: Tetanus
mesh term: Diphtheria
mesh term: Tetany
mesh term: Vaccines
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 