<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/NCT02260882</url>
  </required_header>
  <id_info>
    <org_study_id>V110-902</org_study_id>
    <secondary_id>152859</secondary_id>
    <nct_id>NCT02260882</nct_id>
  </id_info>
  <brief_title>Revaccination With PNEUMOVAX™ 23 in Older Japanese Adults (V110-902)</brief_title>
  <official_title>A Study Evaluating the Safety and Immunogenicity of Revaccination With 23-Valent Pneumococcal Polysaccharide Vaccine in Older Japanese Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Merck Sharp &amp; Dohme LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if revaccination with pneumococcal vaccine&#xD;
      (PNEUMOVAX™ 23, V110) is well tolerated and produces an immune response in older Japanese&#xD;
      adults. The primary hypothesis being tested is that the geometric mean concentration of&#xD;
      antibodies to pneumococcal polysaccharide serotypes 3, 6B, and 23F at 4 weeks after&#xD;
      revaccination will be superior to that before revaccination in Japanese adults who received a&#xD;
      primary vaccination at least 5 years before revaccination.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 31, 2014</start_date>
  <completion_date type="Actual">April 9, 2015</completion_date>
  <primary_completion_date type="Actual">April 9, 2015</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 4 Weeks After Revaccination</measure>
    <time_frame>Baseline and 4 weeks after revaccination</time_frame>
    <description>Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays. Geometric mean antibody concentrations (GMCs) were calculated at Baseline and 4 weeks postvaccination. Geometric Mean Fold Rise was the GMC at 4 weeks after vaccination minus the GMC at Baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 4 Weeks After Primary Vaccination</measure>
    <time_frame>Baseline and 4 weeks after primary vaccination</time_frame>
    <description>Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays. Geometric mean antibody concentrations (GMCs) were calculated at Baseline and 4 weeks postvaccination. Geometric Mean Fold Rise was the GMC at 4 weeks after vaccination minus the GMC at Baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With an Adverse Event of Injection-site Erythema</measure>
    <time_frame>Up to 5 days after vaccination</time_frame>
    <description>An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of injection-site erythema recorded on the Vaccine Report Card (VRC) during the first 5 days after vaccination was recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With an Adverse Event of Injection-site Swelling</measure>
    <time_frame>Up to 5 days after vaccination</time_frame>
    <description>An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of injection-site swelling recorded on the VRC during the first 5 days after vaccination was recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With an Adverse Event of Injection-site Pain</measure>
    <time_frame>Up to 5 days after vaccination</time_frame>
    <description>An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of injection-site pain recorded on the VRC during the first 5 days after vaccination was recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With an Adverse Event of Pyrexia</measure>
    <time_frame>Up to 5 days after vaccination</time_frame>
    <description>Percentage of participants with an adverse event of pyrexia (&gt;=37.5°C, oral) recorded on the VRC during the first 5 days after vaccination was recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With an Adverse Event of Myalgia</measure>
    <time_frame>Up to 14 days after vaccination</time_frame>
    <description>An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of myalgia recorded on the VRC during the first 14 days after vaccination was recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With an Adverse Event of Arthralgia</measure>
    <time_frame>Up to 14 days after vaccination</time_frame>
    <description>An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of arthralgia recorded on the VRC during the first 14 days after vaccination was recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With an Adverse Event of Headache</measure>
    <time_frame>Up to 14 days after vaccination</time_frame>
    <description>An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of headache recorded on the VRC during the first 14 days after vaccination was recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With an Adverse Event of Fatigue</measure>
    <time_frame>Up to 14 days after vaccination</time_frame>
    <description>An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of fatigue recorded on the VRC during the first 14 days after vaccination was recorded.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">243</enrollment>
  <condition>Pneumococcal Infection</condition>
  <arm_group>
    <arm_group_label>Revaccination Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Primary Vaccination Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>PNEUMOVAX™ 23</intervention_name>
    <description>PNEUMOVAX™ 23 (23-Valent Pneumococcal Polysaccharide Vaccination, V110, PPV23)</description>
    <arm_group_label>Primary Vaccination Group</arm_group_label>
    <arm_group_label>Revaccination Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Japanese participant&#xD;
&#xD;
          -  Good health or any underlying chronic illness is documented to be in stable condition&#xD;
&#xD;
          -  Revaccination Group: received one documented PNEUMOVAX™ 23 vaccination at least 5&#xD;
             years before enrollment in the study&#xD;
&#xD;
          -  Primary Vaccination Group: no prior history with PNEUMOVAX™ 23 vaccination Exclusion&#xD;
             Criteria:&#xD;
&#xD;
          -  Known allergy or sensitivity to any of the components of the study vaccine&#xD;
&#xD;
          -  History of pneumococcal conjugate vaccination&#xD;
&#xD;
          -  Known or suspected immune dysfunction, immunosuppression, or autoimmune disease.&#xD;
             Participants with a history of cancer who are not actively treated and not&#xD;
             immunosuppressed will be eligible&#xD;
&#xD;
          -  Functional or anatomic asplenia&#xD;
&#xD;
          -  Received immunoglobulin within 6 months before study vaccine or is planned during the&#xD;
             study&#xD;
&#xD;
          -  Received any investigational drugs or vaccines within 2 months before study&#xD;
             vaccination&#xD;
&#xD;
          -  History of pneumococcal disease (positive culture from blood or other normally sterile&#xD;
             site)&#xD;
&#xD;
          -  Thrombocytopenia or any coagulation disorder that would contraindicate intramuscular&#xD;
             injection&#xD;
&#xD;
          -  History of convulsion&#xD;
&#xD;
          -  Previously diagnosed with immunodeficiency or has a close relative with congenital&#xD;
             immune deficiency&#xD;
&#xD;
          -  Participating in any other clinical trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Merck Sharp &amp; Dohme LLC</affiliation>
  </overall_official>
  <removed_countries>
    <country>Japan</country>
  </removed_countries>
  <results_reference>
    <citation>Kawakami K, Kishino H, Kanazu S, Toshimizu N, Takahashi K, Sterling T, Wang M, Musey L. Revaccination with 23-valent pneumococcal polysaccharide vaccine in the Japanese elderly is well tolerated and elicits immune responses. Vaccine. 2016 Jul 19;34(33):3875-81. doi: 10.1016/j.vaccine.2016.05.052. Epub 2016 Jun 10.</citation>
    <PMID>27265450</PMID>
  </results_reference>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>October 6, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <results_first_submitted>January 19, 2016</results_first_submitted>
  <results_first_submitted_qc>January 19, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">February 17, 2016</results_first_posted>
  <last_update_submitted>October 1, 2018</last_update_submitted>
  <last_update_submitted_qc>October 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumococcal Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heptavalent Pneumococcal Conjugate Vaccine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf</ipd_description>
    <ipd_url>http://engagezone.msd.com/ds_documentation.php</ipd_url>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Depending on prior history of Pneumovax™ 23 vaccination, 161 participants with a history of prior Pneumovax™ 23 vaccination were enrolled into the Revaccination group and 82 participants without a history of prior Pneumovax™ vaccination were enrolled into the Primary vaccination group.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Revaccination Group</title>
          <description>0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.</description>
        </group>
        <group group_id="P2">
          <title>Primary Vaccination Group</title>
          <description>0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="161"/>
                <participants group_id="P2" count="82"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="161"/>
                <participants group_id="P2" count="81"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>One participant in the Primary Vaccination Group was withdrawn from the study before vaccination because of a protocol violation. Baseline Characteristics are based on the Full Analysis Set: participants who received at least one vaccination.</population>
      <group_list>
        <group group_id="B1">
          <title>Revaccination Group</title>
          <description>0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.</description>
        </group>
        <group group_id="B2">
          <title>Primary Vaccination Group</title>
          <description>0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="161"/>
            <count group_id="B2" value="81"/>
            <count group_id="B3" value="242"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="78.8" spread="4.8"/>
                    <measurement group_id="B2" value="78.2" spread="5.0"/>
                    <measurement group_id="B3" value="78.6" spread="4.8"/>
                  </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="94"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="140"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="67"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="102"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 4 Weeks After Revaccination</title>
        <description>Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays. Geometric mean antibody concentrations (GMCs) were calculated at Baseline and 4 weeks postvaccination. Geometric Mean Fold Rise was the GMC at 4 weeks after vaccination minus the GMC at Baseline.</description>
        <time_frame>Baseline and 4 weeks after revaccination</time_frame>
        <population>Per Protocol Set: all participants in the Revaccination Group except those with a protocol deviation, including those with blood collection outside the protocol-specified window.</population>
        <group_list>
          <group group_id="O1">
            <title>Revaccination Group</title>
            <description>0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 4 Weeks After Revaccination</title>
          <description>Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays. Geometric mean antibody concentrations (GMCs) were calculated at Baseline and 4 weeks postvaccination. Geometric Mean Fold Rise was the GMC at 4 weeks after vaccination minus the GMC at Baseline.</description>
          <population>Per Protocol Set: all participants in the Revaccination Group except those with a protocol deviation, including those with blood collection outside the protocol-specified window.</population>
          <units>Geometric Mean 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="161"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serotype 3: n=161</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.72" lower_limit="2.35" upper_limit="3.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 6B: n=161</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.27" lower_limit="2.02" upper_limit="2.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 23F: n=160</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.40" lower_limit="2.12" upper_limit="2.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Serotype 3. The statistical success criterion for demonstrating greater geometric mean antibody concentrations at 4 weeks postvaccination is that the lower bound of the 2-sided 95% confidence interval in Geometric Mean Fold Rise will be greater than 1 for all 3 serotypes.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>t-test, 1 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Serotype 6B. The statistical success criterion for demonstrating greater geometric mean antibody concentrations at 4 weeks postvaccination is that the lower bound of the 2-sided 95% confidence interval in Geometric Mean Fold Rise will be greater than 1 for all 3 serotypes.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>t-test, 1 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Serotype 23F. The statistical success criterion for demonstrating greater geometric mean antibody concentrations at 4 weeks postvaccination is that the lower bound of the 2-sided 95% confidence interval in Geometric Mean Fold Rise will be greater than 1 for all 3 serotypes.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>t-test, 1 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 4 Weeks After Primary Vaccination</title>
        <description>Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays. Geometric mean antibody concentrations (GMCs) were calculated at Baseline and 4 weeks postvaccination. Geometric Mean Fold Rise was the GMC at 4 weeks after vaccination minus the GMC at Baseline.</description>
        <time_frame>Baseline and 4 weeks after primary vaccination</time_frame>
        <population>Per Protocol Set: all participants in the Primary Vaccination Group except those with a protocol deviation, including those with blood collection outside the protocol-specified window</population>
        <group_list>
          <group group_id="O1">
            <title>Primary Vaccination Group</title>
            <description>0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 4 Weeks After Primary Vaccination</title>
          <description>Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays. Geometric mean antibody concentrations (GMCs) were calculated at Baseline and 4 weeks postvaccination. Geometric Mean Fold Rise was the GMC at 4 weeks after vaccination minus the GMC at Baseline.</description>
          <population>Per Protocol Set: all participants in the Primary Vaccination Group except those with a protocol deviation, including those with blood collection outside the protocol-specified window</population>
          <units>Geometric Mean 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="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serotype 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.01" lower_limit="3.17" upper_limit="5.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 6B</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.83" lower_limit="4.41" upper_limit="7.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 23F</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.11" lower_limit="4.65" upper_limit="8.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With an Adverse Event of Injection-site Erythema</title>
        <description>An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of injection-site erythema recorded on the Vaccine Report Card (VRC) during the first 5 days after vaccination was recorded.</description>
        <time_frame>Up to 5 days after vaccination</time_frame>
        <population>All Subjects as Treated set: all participants who received study vaccine.</population>
        <group_list>
          <group group_id="O1">
            <title>Revaccination Group</title>
            <description>0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.</description>
          </group>
          <group group_id="O2">
            <title>Primary Vaccination Group</title>
            <description>0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With an Adverse Event of Injection-site Erythema</title>
          <description>An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of injection-site erythema recorded on the Vaccine Report Card (VRC) during the first 5 days after vaccination was recorded.</description>
          <population>All Subjects as Treated set: all participants who received study vaccine.</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="161"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.4"/>
                    <measurement group_id="O2" value="14.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With an Adverse Event of Injection-site Swelling</title>
        <description>An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of injection-site swelling recorded on the VRC during the first 5 days after vaccination was recorded.</description>
        <time_frame>Up to 5 days after vaccination</time_frame>
        <population>All Subjects as Treated set: all participants who received study vaccine.</population>
        <group_list>
          <group group_id="O1">
            <title>Revaccination Group</title>
            <description>0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.</description>
          </group>
          <group group_id="O2">
            <title>Primary Vaccination Group</title>
            <description>0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With an Adverse Event of Injection-site Swelling</title>
          <description>An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of injection-site swelling recorded on the VRC during the first 5 days after vaccination was recorded.</description>
          <population>All Subjects as Treated set: all participants who received study vaccine.</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="161"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.5"/>
                    <measurement group_id="O2" value="17.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With an Adverse Event of Injection-site Pain</title>
        <description>An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of injection-site pain recorded on the VRC during the first 5 days after vaccination was recorded.</description>
        <time_frame>Up to 5 days after vaccination</time_frame>
        <population>All Subjects as Treated set: all participants who received study vaccine.</population>
        <group_list>
          <group group_id="O1">
            <title>Revaccination Group</title>
            <description>0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.</description>
          </group>
          <group group_id="O2">
            <title>Primary Vaccination Group</title>
            <description>0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With an Adverse Event of Injection-site Pain</title>
          <description>An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of injection-site pain recorded on the VRC during the first 5 days after vaccination was recorded.</description>
          <population>All Subjects as Treated set: all participants who received study vaccine.</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="161"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.7"/>
                    <measurement group_id="O2" value="46.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With an Adverse Event of Pyrexia</title>
        <description>Percentage of participants with an adverse event of pyrexia (&gt;=37.5°C, oral) recorded on the VRC during the first 5 days after vaccination was recorded.</description>
        <time_frame>Up to 5 days after vaccination</time_frame>
        <population>All Subjects as Treated set: all participants who received study vaccine.</population>
        <group_list>
          <group group_id="O1">
            <title>Revaccination Group</title>
            <description>0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.</description>
          </group>
          <group group_id="O2">
            <title>Primary Vaccination Group</title>
            <description>0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With an Adverse Event of Pyrexia</title>
          <description>Percentage of participants with an adverse event of pyrexia (&gt;=37.5°C, oral) recorded on the VRC during the first 5 days after vaccination was recorded.</description>
          <population>All Subjects as Treated set: all participants who received study vaccine.</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="161"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.8"/>
                    <measurement group_id="O2" value="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With an Adverse Event of Myalgia</title>
        <description>An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of myalgia recorded on the VRC during the first 14 days after vaccination was recorded.</description>
        <time_frame>Up to 14 days after vaccination</time_frame>
        <population>All Subjects as Treated set: all participants who received study vaccine.</population>
        <group_list>
          <group group_id="O1">
            <title>Revaccination Group</title>
            <description>0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.</description>
          </group>
          <group group_id="O2">
            <title>Primary Vaccination Group</title>
            <description>0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With an Adverse Event of Myalgia</title>
          <description>An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of myalgia recorded on the VRC during the first 14 days after vaccination was recorded.</description>
          <population>All Subjects as Treated set: all participants who received study vaccine.</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="161"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With an Adverse Event of Arthralgia</title>
        <description>An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of arthralgia recorded on the VRC during the first 14 days after vaccination was recorded.</description>
        <time_frame>Up to 14 days after vaccination</time_frame>
        <population>All Subjects as Treated set: all participants who received study vaccine.</population>
        <group_list>
          <group group_id="O1">
            <title>Revaccination Group</title>
            <description>0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.</description>
          </group>
          <group group_id="O2">
            <title>Primary Vaccination Group</title>
            <description>0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With an Adverse Event of Arthralgia</title>
          <description>An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of arthralgia recorded on the VRC during the first 14 days after vaccination was recorded.</description>
          <population>All Subjects as Treated set: all participants who received study vaccine.</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="161"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With an Adverse Event of Headache</title>
        <description>An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of headache recorded on the VRC during the first 14 days after vaccination was recorded.</description>
        <time_frame>Up to 14 days after vaccination</time_frame>
        <population>All Subjects as Treated set: all participants who received study vaccine.</population>
        <group_list>
          <group group_id="O1">
            <title>Revaccination Group</title>
            <description>0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.</description>
          </group>
          <group group_id="O2">
            <title>Primary Vaccination Group</title>
            <description>0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With an Adverse Event of Headache</title>
          <description>An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of headache recorded on the VRC during the first 14 days after vaccination was recorded.</description>
          <population>All Subjects as Treated set: all participants who received study vaccine.</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="161"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9"/>
                    <measurement group_id="O2" value="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With an Adverse Event of Fatigue</title>
        <description>An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of fatigue recorded on the VRC during the first 14 days after vaccination was recorded.</description>
        <time_frame>Up to 14 days after vaccination</time_frame>
        <population>All Subjects as Treated set: all participants who received study vaccine.</population>
        <group_list>
          <group group_id="O1">
            <title>Revaccination Group</title>
            <description>0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.</description>
          </group>
          <group group_id="O2">
            <title>Primary Vaccination Group</title>
            <description>0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With an Adverse Event of Fatigue</title>
          <description>An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of fatigue recorded on the VRC during the first 14 days after vaccination was recorded.</description>
          <population>All Subjects as Treated set: all participants who received study vaccine.</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="161"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All adverse events: up to 14 days after vaccination; deaths and vaccine-related serious adverse events: up to 36 days after vaccination</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Revaccination Group</title>
          <description>0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.</description>
        </group>
        <group group_id="E2">
          <title>Primary Vaccination Group</title>
          <description>0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 17.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="161"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Herpes virus infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="161"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Femoral neck fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="161"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Bronchitis chronic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="161"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 17.1</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="113" subjects_at_risk="161"/>
                <counts group_id="E2" subjects_affected="41" subjects_at_risk="81"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection-site erythema</sub_title>
                <counts group_id="E1" events="57" subjects_affected="57" subjects_at_risk="161"/>
                <counts group_id="E2" events="12" subjects_affected="12" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>Injection-site pain</sub_title>
                <counts group_id="E1" events="102" subjects_affected="101" subjects_at_risk="161"/>
                <counts group_id="E2" events="38" subjects_affected="38" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>Injection-site pruritus</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="161"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>Injection-site swelling</sub_title>
                <counts group_id="E1" events="62" subjects_affected="62" subjects_at_risk="161"/>
                <counts group_id="E2" events="14" subjects_affected="14" subjects_at_risk="81"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="161"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="81"/>
              </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 investigator agrees not to publish or publicly present any interim results of the trial without the prior written consent of the sponsor. The investigator further agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Senior Vice President, Global Clinical Development</name_or_title>
      <organization>Merck Sharp &amp; Dohme Corp.</organization>
      <phone>1-800-672-6372</phone>
      <email>ClinicalTrialsDisclosure@merck.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/NCT02260882
org study id: V110-902
secondary id: 152859
nct id: NCT02260882
lead sponsor: 
has dmc: No
The purpose of this study is to determine if revaccination with pneumococcal vaccine
      (PNEUMOVAX™ 23, V110) is well tolerated and produces an immune response in older Japanese
      adults. The primary hypothesis being tested is that the geometric mean concentration of
      antibodies to pneumococcal polysaccharide serotypes 3, 6B, and 23F at 4 weeks after
      revaccination will be superior to that before revaccination in Japanese adults who received a
      primary vaccination at least 5 years before revaccination.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change From Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 4 Weeks After Revaccination
time frame: Baseline and 4 weeks after revaccination
description: Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays. Geometric mean antibody concentrations (GMCs) were calculated at Baseline and 4 weeks postvaccination. Geometric Mean Fold Rise was the GMC at 4 weeks after vaccination minus the GMC at Baseline.
measure: Change From Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 4 Weeks After Primary Vaccination
time frame: Baseline and 4 weeks after primary vaccination
description: Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays. Geometric mean antibody concentrations (GMCs) were calculated at Baseline and 4 weeks postvaccination. Geometric Mean Fold Rise was the GMC at 4 weeks after vaccination minus the GMC at Baseline.
measure: Percentage of Participants With an Adverse Event of Injection-site Erythema
time frame: Up to 5 days after vaccination
description: An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of injection-site erythema recorded on the Vaccine Report Card (VRC) during the first 5 days after vaccination was recorded.
measure: Percentage of Participants With an Adverse Event of Injection-site Swelling
time frame: Up to 5 days after vaccination
description: An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of injection-site swelling recorded on the VRC during the first 5 days after vaccination was recorded.
measure: Percentage of Participants With an Adverse Event of Injection-site Pain
time frame: Up to 5 days after vaccination
description: An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of injection-site pain recorded on the VRC during the first 5 days after vaccination was recorded.
measure: Percentage of Participants With an Adverse Event of Pyrexia
time frame: Up to 5 days after vaccination
description: Percentage of participants with an adverse event of pyrexia (>=37.5°C, oral) recorded on the VRC during the first 5 days after vaccination was recorded.
measure: Percentage of Participants With an Adverse Event of Myalgia
time frame: Up to 14 days after vaccination
description: An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of myalgia recorded on the VRC during the first 14 days after vaccination was recorded.
measure: Percentage of Participants With an Adverse Event of Arthralgia
time frame: Up to 14 days after vaccination
description: An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of arthralgia recorded on the VRC during the first 14 days after vaccination was recorded.
measure: Percentage of Participants With an Adverse Event of Headache
time frame: Up to 14 days after vaccination
description: An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of headache recorded on the VRC during the first 14 days after vaccination was recorded.
measure: Percentage of Participants With an Adverse Event of Fatigue
time frame: Up to 14 days after vaccination
description: An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of fatigue recorded on the VRC during the first 14 days after vaccination was recorded.
arm group label: Revaccination Group
arm group type: Experimental
description: 0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior
arm group label: Primary Vaccination Group
arm group type: Experimental
description: 0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination
intervention type: Biological
intervention name: PNEUMOVAX™ 23
description: PNEUMOVAX™ 23 (23-Valent Pneumococcal Polysaccharide Vaccination, V110, PPV23)
arm group label: Primary Vaccination Group
arm group label: Revaccination Group
criteria: 
gender: All
minimum age: 70 Years
maximum age: 89 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Medical Director
role: Study Director
affiliation: Merck Sharp & Dohme LLC
country: Japan
citation: Kawakami K, Kishino H, Kanazu S, Toshimizu N, Takahashi K, Sterling T, Wang M, Musey L. Revaccination with 23-valent pneumococcal polysaccharide vaccine in the Japanese elderly is well tolerated and elicits immune responses. Vaccine. 2016 Jul 19;34(33):3875-81. doi: 10.1016/j.vaccine.2016.05.052. Epub 2016 Jun 10.
PMID: 27265450
responsible party type: Sponsor
mesh term: Pneumococcal Infections
mesh term: Heptavalent Pneumococcal Conjugate Vaccine
sharing ipd: Yes
ipd description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
ipd url: http://engagezone.msd.com/ds_documentation.php
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 