<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/NCT02225587</url>
  </required_header>
  <id_info>
    <org_study_id>V110-029</org_study_id>
    <secondary_id>2013-003027-11</secondary_id>
    <secondary_id>V110-029</secondary_id>
    <nct_id>NCT02225587</nct_id>
  </id_info>
  <brief_title>Evaluation of the Safety and Immunogenicity of Sequential Administration of Prevnar 13™ and Pneumovax™ 23 in Healthy Participants 50 Years of Age and Older (V110-029)</brief_title>
  <official_title>Sequential Administration of Prevnar 13™ and Pneumovax™ 23 in Healthy Subjects 50 Years of Age and Older</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>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety and immunogenicity of sequential&#xD;
      administration of Prevnar 13™ and Pneumovax™ 23 in healthy participants 50 years of age and&#xD;
      older. The primary hypotheses in the study are that 1) geometric mean titers (GMTs) to&#xD;
      pneumococcal serotypes 22F and 33F (serotypes in Pneumovax™ 23 but not in Prevnar 13™) as&#xD;
      measured at Week 12 are superior in participants administered Prevnar 13™ on Day 1 and&#xD;
      Pneumovax™ 23 at Week 8, as compared with participants administered Prevnar 13™ on Day 1 and&#xD;
      placebo at Week 8 and 2) GMTs to pneumococcal serotypes shared by the two vaccines as&#xD;
      measured at Week 12 are non-inferior in participants administered Prevnar 13™ followed by&#xD;
      Pneumovax™ 23 as compared with participants administered Prevnar 13™ followed by placebo.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 28, 2014</start_date>
  <completion_date type="Actual">July 6, 2015</completion_date>
  <primary_completion_date type="Actual">July 6, 2015</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With an Adverse Event (AE)</measure>
    <time_frame>Up to 14 days after any vaccination (Up to 28 weeks)</time_frame>
    <description>An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With an Injection-site Adverse Event</measure>
    <time_frame>Up to 14 days after any vaccination (Up to 28 weeks)</time_frame>
    <description>An injection site adverse event (AE) includes the following AEs at the injection site: redness, swelling, and pain/tenderness.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With a Systemic Adverse Event</measure>
    <time_frame>Up to 14 days after any vaccination (Up to 28 weeks)</time_frame>
    <description>Systemic adverse events (AEs) include, but are not restricted to the following AE terms: muscle pain, joint pain, headache, and tiredness.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With a Serious Adverse Event (SAE)</measure>
    <time_frame>Up to 30 weeks</time_frame>
    <description>A serious adverse event (SAE) is any adverse event occurring at any dose or during any use of Sponsor's product that: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is another important medical event; is a cancer; or is associated with an overdose.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE) or Vaccine-related Death</measure>
    <time_frame>Up to 30 weeks</time_frame>
    <description>A serious adverse event (SAE) is any adverse event occurring at any dose or during any use of Sponsor's product that: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is another important medical event; is a cancer; or is associated with an overdose. The investigator determined whether the SAE or death was related to vaccine treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Discontinued Vaccination Due to an Adverse Event</measure>
    <time_frame>Up to 26 weeks</time_frame>
    <description>An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Geometric Mean Titers to Pneumococcal Serotypes 22F and 33F at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>Vaccine-induced functional antibodies to serotypes 22F and 33F, which are unique to PNEUMOVAX™ 23, were measured by the multiplex opsonophagocytic activity 4 (MOPA-4) assay, which is based on the ability of antibody in the serum to initiate killing of bacterial pneumococci.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>Vaccine-induced functional antibodies to serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, which are contained in both Prevnar 13™ and PNEUMOVAX™ 23, were measured by the MOPA-4 assay, which is based on the ability of antibody in the serum to initiate killing of bacterial pneumococci.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F at Week 8</measure>
    <time_frame>Week 8</time_frame>
    <description>Vaccine-induced functional antibodies were measured by the MOPA-4 assay, which is based on the ability of antibody in the serum to initiate killing of bacterial pneumococci.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F at Week 26</measure>
    <time_frame>Week 26</time_frame>
    <description>Vaccine-induced functional antibodies were measured by the MOPA-4 assay, which is based on the ability of antibody in the serum to initiate killing of bacterial pneumococci.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F at Week 30</measure>
    <time_frame>Week 30</time_frame>
    <description>Vaccine-induced functional antibodies were measured by the MOPA-4 assay, which is based on the ability of antibody in the serum to initiate killing of bacterial pneumococci.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">400</enrollment>
  <condition>Pneumococcal Infections</condition>
  <arm_group>
    <arm_group_label>Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Pneumovax™ 23 0.5 mL intramuscular injection at Week 8, and Placebo 0.5 mL intramuscular injection at Week 26. Injections are to be administered in alternating limbs, if possible.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Placebo 0.5 mL intramuscular injection at Week 8, and Pneumovax™ 23 0.5 mL intramuscular injection at Week 26. Injections are to be administered in alternating limbs, if possible.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Prevnar 13™</intervention_name>
    <description>Pneumococcal vaccine containing serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. Injections are to be administered into the deltoid muscle of the upper arm.</description>
    <arm_group_label>Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo</arm_group_label>
    <arm_group_label>Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Pneumovax™ 23</intervention_name>
    <description>Pneumococcal vaccine containing serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F. Injections are to be administered into the deltoid muscle of the upper arm.</description>
    <arm_group_label>Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo</arm_group_label>
    <arm_group_label>Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Injections are to be administered into the deltoid muscle of the upper arm.</description>
    <arm_group_label>Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo</arm_group_label>
    <arm_group_label>Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any chronic illness must be documented to be in stable condition&#xD;
&#xD;
          -  Male, or a female agrees to remain abstinent, or use, or have their partner use, 2&#xD;
             acceptable methods of contraception through 6 weeks after receiving study vaccination;&#xD;
             or a female who is not of reproductive potential&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Is or has an immediate family member who is investigational site or sponsor staff&#xD;
             directly involved with this trial&#xD;
&#xD;
          -  Prior administration of any pneumococcal vaccine&#xD;
&#xD;
          -  History of invasive pneumococcal disease&#xD;
&#xD;
          -  Known hypersensitivity to any component of the pneumococcal polysaccharide vaccine, of&#xD;
             the pneumococcal conjugate vaccine, or any diphtheria toxoid-containing vaccine&#xD;
&#xD;
          -  Known or suspected impairment of immunological function, documented Human&#xD;
             Immunodeficiency Virus (HIV) infection, asplenia, or history of autoimmune disease&#xD;
&#xD;
          -  Received systemic corticosteroids (equivalent of &gt;=2 mg/kg total daily dose of&#xD;
             prednisone or &gt;=20 mg/kg for persons weighing &gt;10 kg) for &gt;=14 consecutive days and&#xD;
             has not completed treatment &lt;=30 days before study vaccination, or has received&#xD;
             systemic corticosteroids exceeding physiological doses (~5 mg/day prednisone&#xD;
             equivalent) within 14 days before study vaccination (topical, ophthalmic,&#xD;
             intra-articular, and inhaled/nebulized steroids are permitted).&#xD;
&#xD;
          -  Has a coagulation disorder contraindicating intramuscular vaccination&#xD;
&#xD;
          -  Receiving immunosuppressive therapy, including chemotherapeutic agents used to treat&#xD;
             cancer or other conditions, and treatments associated with organ or bone marrow&#xD;
             transplantation or autoimmune disease&#xD;
&#xD;
          -  Received a blood transfusion or blood products, including immunoglobulins &lt;=6 months&#xD;
             before receiving study vaccine, or is scheduled to receive them within 30 days&#xD;
&#xD;
          -  Participated in another clinical study of an investigational product &lt;=2 months before&#xD;
             or during the current study&#xD;
&#xD;
          -  Is breast-feeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</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>United States</country>
  </removed_countries>
  <results_reference>
    <citation>Buchwald UK, Andrews CP, Ervin J, Peterson JT, Tamms GM, Krupa D, Ajiboye P, Roalfe L, Krick AL, Sterling TM, Wang M, Martin JC, Stek JE, Kohn MA, Folaranmi T, Abeygunawardana C, Hartzel J, Musey LK; V110-029 Study Group. Sequential administration of Prevnar 13 and PNEUMOVAX 23 in healthy participants 50 years of age and older. Hum Vaccin Immunother. 2021 Aug 3;17(8):2678-2690. doi: 10.1080/21645515.2021.1888621. Epub 2021 May 21.</citation>
    <PMID>34019468</PMID>
  </results_reference>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>August 22, 2014</study_first_submitted>
  <study_first_submitted_qc>August 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 26, 2014</study_first_posted>
  <results_first_submitted>November 26, 2019</results_first_submitted>
  <results_first_submitted_qc>January 28, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">February 5, 2020</results_first_posted>
  <disposition_first_submitted>June 16, 2016</disposition_first_submitted>
  <disposition_first_submitted_qc>June 16, 2016</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">July 11, 2016</disposition_first_posted>
  <last_update_submitted>October 25, 2021</last_update_submitted>
  <last_update_submitted_qc>October 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2021</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>http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf</ipd_description>
    <ipd_url>http://engagezone.msd.com/ds_documentation.php</ipd_url>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo</title>
          <description>Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Pneumovax™ 23 0.5 mL intramuscular injection at Week 8, and Placebo 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.</description>
        </group>
        <group group_id="P2">
          <title>Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23</title>
          <description>Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Placebo 0.5 mL intramuscular injection at Week 8, and Pneumovax™ 23 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="200"/>
                <participants group_id="P2" count="200"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Vaccination 2</title>
              <participants_list>
                <participants group_id="P1" count="188"/>
                <participants group_id="P2" count="185"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Vaccination 3</title>
              <participants_list>
                <participants group_id="P1" count="172"/>
                <participants group_id="P2" count="164"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="172"/>
                <participants group_id="P2" count="162"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="38"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-Compliance With Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant Moved</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="28"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo</title>
          <description>Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Pneumovax™ 23 0.5 mL intramuscular injection at Week 8, and Placebo 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.</description>
        </group>
        <group group_id="B2">
          <title>Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23</title>
          <description>Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Placebo 0.5 mL intramuscular injection at Week 8, and Pneumovax™ 23 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.</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="200"/>
            <count group_id="B2" value="200"/>
            <count group_id="B3" value="400"/>
          </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="64.1" spread="8.6"/>
                    <measurement group_id="B2" value="64.2" spread="8.9"/>
                    <measurement group_id="B3" value="64.2" spread="8.7"/>
                  </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="112"/>
                    <measurement group_id="B2" value="107"/>
                    <measurement group_id="B3" value="219"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="88"/>
                    <measurement group_id="B2" value="93"/>
                    <measurement group_id="B3" value="181"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="75"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="158"/>
                    <measurement group_id="B2" value="164"/>
                    <measurement group_id="B3" value="322"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="176"/>
                    <measurement group_id="B2" value="163"/>
                    <measurement group_id="B3" value="339"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With an Adverse Event (AE)</title>
        <description>An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.</description>
        <time_frame>Up to 14 days after any vaccination (Up to 28 weeks)</time_frame>
        <population>Participants who received at least 1 dose of treatment and followed up for safety. Two participants from Group 1, and 1 participant from Group 2 were not analyzed due to lack of follow-up data. As the objective was to report the combined safety of the two vaccines given 8 or 26 weeks apart, results are presented for the sequence of vaccinations.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo</title>
            <description>Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Pneumovax™ 23 0.5 mL intramuscular injection at Week 8, and Placebo 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23</title>
            <description>Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Placebo 0.5 mL intramuscular injection at Week 8, and Pneumovax™ 23 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With an Adverse Event (AE)</title>
          <description>An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.</description>
          <population>Participants who received at least 1 dose of treatment and followed up for safety. Two participants from Group 1, and 1 participant from Group 2 were not analyzed due to lack of follow-up data. As the objective was to report the combined safety of the two vaccines given 8 or 26 weeks apart, results are presented for the sequence of vaccinations.</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="198"/>
                <count group_id="O2" value="199"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.9"/>
                    <measurement group_id="O2" value="84.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With an Injection-site Adverse Event</title>
        <description>An injection site adverse event (AE) includes the following AEs at the injection site: redness, swelling, and pain/tenderness.</description>
        <time_frame>Up to 14 days after any vaccination (Up to 28 weeks)</time_frame>
        <population>Participants who received at least 1 dose of treatment and followed up for safety. Two participants from Group 1, and 1 participant from Group 2 were not analyzed due to lack of follow-up data. As the objective was to report the combined safety of the two vaccines given 8 or 26 weeks apart, results are presented for the sequence of vaccinations.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo</title>
            <description>Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Pneumovax™ 23 0.5 mL intramuscular injection at Week 8, and Placebo 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23</title>
            <description>Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Placebo 0.5 mL intramuscular injection at Week 8, and Pneumovax™ 23 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With an Injection-site Adverse Event</title>
          <description>An injection site adverse event (AE) includes the following AEs at the injection site: redness, swelling, and pain/tenderness.</description>
          <population>Participants who received at least 1 dose of treatment and followed up for safety. Two participants from Group 1, and 1 participant from Group 2 were not analyzed due to lack of follow-up data. As the objective was to report the combined safety of the two vaccines given 8 or 26 weeks apart, results are presented for the sequence of vaccinations.</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="198"/>
                <count group_id="O2" value="199"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.4"/>
                    <measurement group_id="O2" value="77.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With a Systemic Adverse Event</title>
        <description>Systemic adverse events (AEs) include, but are not restricted to the following AE terms: muscle pain, joint pain, headache, and tiredness.</description>
        <time_frame>Up to 14 days after any vaccination (Up to 28 weeks)</time_frame>
        <population>Participants who received at least 1 dose of treatment and followed up for safety. Two participants from Group 1, and 1 participant from Group 2 were not analyzed due to lack of follow-up data. As the objective was to report the combined safety of the two vaccines given 8 or 26 weeks apart, results are presented for the sequence of vaccinations.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo</title>
            <description>Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Pneumovax™ 23 0.5 mL intramuscular injection at Week 8, and Placebo 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23</title>
            <description>Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Placebo 0.5 mL intramuscular injection at Week 8, and Pneumovax™ 23 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a Systemic Adverse Event</title>
          <description>Systemic adverse events (AEs) include, but are not restricted to the following AE terms: muscle pain, joint pain, headache, and tiredness.</description>
          <population>Participants who received at least 1 dose of treatment and followed up for safety. Two participants from Group 1, and 1 participant from Group 2 were not analyzed due to lack of follow-up data. As the objective was to report the combined safety of the two vaccines given 8 or 26 weeks apart, results are presented for the sequence of vaccinations.</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="198"/>
                <count group_id="O2" value="199"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.8"/>
                    <measurement group_id="O2" value="74.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With a Serious Adverse Event (SAE)</title>
        <description>A serious adverse event (SAE) is any adverse event occurring at any dose or during any use of Sponsor's product that: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is another important medical event; is a cancer; or is associated with an overdose.</description>
        <time_frame>Up to 30 weeks</time_frame>
        <population>Participants who received at least 1 dose of treatment and followed up for safety. Two participants from Group 1, and 1 participant from Group 2 were not analyzed due to lack of follow-up data. As the objective was to report the combined safety of the two vaccines given 8 or 26 weeks apart, results are presented for the sequence of vaccinations.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo</title>
            <description>Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Pneumovax™ 23 0.5 mL intramuscular injection at Week 8, and Placebo 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23</title>
            <description>Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Placebo 0.5 mL intramuscular injection at Week 8, and Pneumovax™ 23 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a Serious Adverse Event (SAE)</title>
          <description>A serious adverse event (SAE) is any adverse event occurring at any dose or during any use of Sponsor's product that: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is another important medical event; is a cancer; or is associated with an overdose.</description>
          <population>Participants who received at least 1 dose of treatment and followed up for safety. Two participants from Group 1, and 1 participant from Group 2 were not analyzed due to lack of follow-up data. As the objective was to report the combined safety of the two vaccines given 8 or 26 weeks apart, results are presented for the sequence of vaccinations.</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="198"/>
                <count group_id="O2" value="199"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5"/>
                    <measurement group_id="O2" value="5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE) or Vaccine-related Death</title>
        <description>A serious adverse event (SAE) is any adverse event occurring at any dose or during any use of Sponsor's product that: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is another important medical event; is a cancer; or is associated with an overdose. The investigator determined whether the SAE or death was related to vaccine treatment.</description>
        <time_frame>Up to 30 weeks</time_frame>
        <population>Participants who received at least 1 dose of treatment and followed up for safety. Two participants from Group 1, and 1 participant from Group 2 were not analyzed due to lack of follow-up data. As the objective was to report the combined safety of the two vaccines given 8 or 26 weeks apart, results are presented for the sequence of vaccinations.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo</title>
            <description>Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Pneumovax™ 23 0.5 mL intramuscular injection at Week 8, and Placebo 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23</title>
            <description>Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Placebo 0.5 mL intramuscular injection at Week 8, and Pneumovax™ 23 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE) or Vaccine-related Death</title>
          <description>A serious adverse event (SAE) is any adverse event occurring at any dose or during any use of Sponsor's product that: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is another important medical event; is a cancer; or is associated with an overdose. The investigator determined whether the SAE or death was related to vaccine treatment.</description>
          <population>Participants who received at least 1 dose of treatment and followed up for safety. Two participants from Group 1, and 1 participant from Group 2 were not analyzed due to lack of follow-up data. As the objective was to report the combined safety of the two vaccines given 8 or 26 weeks apart, results are presented for the sequence of vaccinations.</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="198"/>
                <count group_id="O2" value="199"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Discontinued Vaccination Due to an Adverse Event</title>
        <description>An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.</description>
        <time_frame>Up to 26 weeks</time_frame>
        <population>Participants who received at least 1 dose of treatment and followed up for safety. Two participants from Group 1, and 1 participant from Group 2 were not analyzed due to lack of follow-up data. As the objective was to report the combined safety of the two vaccines given 8 or 26 weeks apart, results are presented for the sequence of vaccinations.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo</title>
            <description>Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Pneumovax™ 23 0.5 mL intramuscular injection at Week 8, and Placebo 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23</title>
            <description>Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Placebo 0.5 mL intramuscular injection at Week 8, and Pneumovax™ 23 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Discontinued Vaccination Due to an Adverse Event</title>
          <description>An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.</description>
          <population>Participants who received at least 1 dose of treatment and followed up for safety. Two participants from Group 1, and 1 participant from Group 2 were not analyzed due to lack of follow-up data. As the objective was to report the combined safety of the two vaccines given 8 or 26 weeks apart, results are presented for the sequence of vaccinations.</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="198"/>
                <count group_id="O2" value="199"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5"/>
                    <measurement group_id="O2" value="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Geometric Mean Titers to Pneumococcal Serotypes 22F and 33F at Week 12</title>
        <description>Vaccine-induced functional antibodies to serotypes 22F and 33F, which are unique to PNEUMOVAX™ 23, were measured by the multiplex opsonophagocytic activity 4 (MOPA-4) assay, which is based on the ability of antibody in the serum to initiate killing of bacterial pneumococci.</description>
        <time_frame>Week 12</time_frame>
        <population>All randomized participants who received at least 1 vaccination and provided serology data for the particular serotype tested; with appropriate day ranges for vaccinations and blood draws, and excludes participants with important deviations from the protocol that may substantially affect the results.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo</title>
            <description>Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Pneumovax™ 23 0.5 mL intramuscular injection at Week 8, and Placebo 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23</title>
            <description>Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Placebo 0.5 mL intramuscular injection at Week 8, and Pneumovax™ 23 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titers to Pneumococcal Serotypes 22F and 33F at Week 12</title>
          <description>Vaccine-induced functional antibodies to serotypes 22F and 33F, which are unique to PNEUMOVAX™ 23, were measured by the multiplex opsonophagocytic activity 4 (MOPA-4) assay, which is based on the ability of antibody in the serum to initiate killing of bacterial pneumococci.</description>
          <population>All randomized participants who received at least 1 vaccination and provided serology data for the particular serotype tested; with appropriate day ranges for vaccinations and blood draws, and excludes participants with important deviations from the protocol that may substantially affect the results.</population>
          <units>Titer</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="172"/>
                <count group_id="O2" value="172"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serotype 22F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="166"/>
                    <count group_id="O2" value="157"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1766.3" lower_limit="1303.2" upper_limit="2394.1"/>
                    <measurement group_id="O2" value="39.0" lower_limit="28.3" upper_limit="53.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 33F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="172"/>
                    <count group_id="O2" value="172"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10413.0" lower_limit="8178.9" upper_limit="13257.4"/>
                    <measurement group_id="O2" value="1189.9" lower_limit="898.6" upper_limit="1575.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, at Week 12</title>
        <description>Vaccine-induced functional antibodies to serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, which are contained in both Prevnar 13™ and PNEUMOVAX™ 23, were measured by the MOPA-4 assay, which is based on the ability of antibody in the serum to initiate killing of bacterial pneumococci.</description>
        <time_frame>Week 12</time_frame>
        <population>All randomized participants who received at least 1 vaccination and provided serology data for the particular serotype tested; with appropriate day ranges for vaccinations and blood draws, and excludes participants with important deviations from the protocol that may substantially affect the results.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo</title>
            <description>Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Pneumovax™ 23 0.5 mL intramuscular injection at Week 8, and Placebo 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23</title>
            <description>Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Placebo 0.5 mL intramuscular injection at Week 8, and Pneumovax™ 23 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, at Week 12</title>
          <description>Vaccine-induced functional antibodies to serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, which are contained in both Prevnar 13™ and PNEUMOVAX™ 23, were measured by the MOPA-4 assay, which is based on the ability of antibody in the serum to initiate killing of bacterial pneumococci.</description>
          <population>All randomized participants who received at least 1 vaccination and provided serology data for the particular serotype tested; with appropriate day ranges for vaccinations and blood draws, and excludes participants with important deviations from the protocol that may substantially affect the results.</population>
          <units>Titer</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="172"/>
                <count group_id="O2" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serotype 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="168"/>
                    <count group_id="O2" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.7" lower_limit="60.4" upper_limit="110.7"/>
                    <measurement group_id="O2" value="57.1" lower_limit="41.1" upper_limit="79.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="151"/>
                    <count group_id="O2" value="155"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.4" lower_limit="33.7" upper_limit="55.9"/>
                    <measurement group_id="O2" value="17.5" lower_limit="13.5" upper_limit="22.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="171"/>
                    <count group_id="O2" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1079.3" lower_limit="885.7" upper_limit="1315.2"/>
                    <measurement group_id="O2" value="780.0" lower_limit="629.1" upper_limit="967.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="171"/>
                    <count group_id="O2" value="178"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="198.6" lower_limit="145.6" upper_limit="271.0"/>
                    <measurement group_id="O2" value="148.4" lower_limit="107.9" upper_limit="204.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 6B</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="170"/>
                    <count group_id="O2" value="179"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1956.9" lower_limit="1575.3" upper_limit="2431.0"/>
                    <measurement group_id="O2" value="1148.1" lower_limit="889.0" upper_limit="1482.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 7F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="172"/>
                    <count group_id="O2" value="179"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2250.8" lower_limit="1889.3" upper_limit="2681.5"/>
                    <measurement group_id="O2" value="1751.8" lower_limit="1422.4" upper_limit="2157.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 9V</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="164"/>
                    <count group_id="O2" value="175"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1472.3" lower_limit="1190.9" upper_limit="1820.2"/>
                    <measurement group_id="O2" value="1017.6" lower_limit="790.8" upper_limit="1309.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="172"/>
                    <count group_id="O2" value="178"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2106.8" lower_limit="1689.6" upper_limit="2627.0"/>
                    <measurement group_id="O2" value="1945.0" lower_limit="1572.9" upper_limit="2405.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 18C</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="171"/>
                    <count group_id="O2" value="175"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2101.9" lower_limit="1732.6" upper_limit="2550.0"/>
                    <measurement group_id="O2" value="1587.1" lower_limit="1259.1" upper_limit="2000.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 19A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="172"/>
                    <count group_id="O2" value="179"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1785.8" lower_limit="1506.1" upper_limit="2117.6"/>
                    <measurement group_id="O2" value="1425.9" lower_limit="1164.7" upper_limit="1745.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 19F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="171"/>
                    <count group_id="O2" value="178"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1051.0" lower_limit="862.1" upper_limit="1281.3"/>
                    <measurement group_id="O2" value="627.2" lower_limit="490.5" upper_limit="802.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 23F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="164"/>
                    <count group_id="O2" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1155.6" lower_limit="867.2" upper_limit="1539.9"/>
                    <measurement group_id="O2" value="716.9" lower_limit="521.1" upper_limit="986.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F at Week 8</title>
        <description>Vaccine-induced functional antibodies were measured by the MOPA-4 assay, which is based on the ability of antibody in the serum to initiate killing of bacterial pneumococci.</description>
        <time_frame>Week 8</time_frame>
        <population>All randomized participants who received at least 1 vaccination and provided serology data for the particular serotype tested; with appropriate day ranges for vaccinations and blood draws, and excludes participants with important deviations from the protocol that may substantially affect the results.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo</title>
            <description>Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Pneumovax™ 23 0.5 mL intramuscular injection at Week 8, and Placebo 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23</title>
            <description>Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Placebo 0.5 mL intramuscular injection at Week 8, and Pneumovax™ 23 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F at Week 8</title>
          <description>Vaccine-induced functional antibodies were measured by the MOPA-4 assay, which is based on the ability of antibody in the serum to initiate killing of bacterial pneumococci.</description>
          <population>All randomized participants who received at least 1 vaccination and provided serology data for the particular serotype tested; with appropriate day ranges for vaccinations and blood draws, and excludes participants with important deviations from the protocol that may substantially affect the results.</population>
          <units>Titer</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 group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serotype 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.7" lower_limit="50.5" upper_limit="200.9"/>
                    <measurement group_id="O2" value="54.7" lower_limit="27.5" upper_limit="108.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.8" lower_limit="32.2" upper_limit="86.5"/>
                    <measurement group_id="O2" value="27.8" lower_limit="16.6" upper_limit="46.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1075.7" lower_limit="671.4" upper_limit="1723.5"/>
                    <measurement group_id="O2" value="1051.0" lower_limit="696.0" upper_limit="1587.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="350.5" lower_limit="193.2" upper_limit="636.1"/>
                    <measurement group_id="O2" value="143.9" lower_limit="77.7" upper_limit="266.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 6A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3945.3" lower_limit="2301.9" upper_limit="6762.2"/>
                    <measurement group_id="O2" value="4024.1" lower_limit="2622.8" upper_limit="6174.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 6B</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2154.2" lower_limit="1325.4" upper_limit="3501.3"/>
                    <measurement group_id="O2" value="1259.7" lower_limit="707.3" upper_limit="2243.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 7F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3830.5" lower_limit="2654.6" upper_limit="5527.2"/>
                    <measurement group_id="O2" value="2064.0" lower_limit="1287.4" upper_limit="3309.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 9V</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1555.6" lower_limit="988.7" upper_limit="2447.6"/>
                    <measurement group_id="O2" value="1606.5" lower_limit="1064.5" upper_limit="2424.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2417.0" lower_limit="1547.8" upper_limit="3774.1"/>
                    <measurement group_id="O2" value="1586.4" lower_limit="901.6" upper_limit="2791.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 18C</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1890.8" lower_limit="1313.3" upper_limit="2722.1"/>
                    <measurement group_id="O2" value="1563.7" lower_limit="857.8" upper_limit="2850.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 19A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2102.3" lower_limit="1567.6" upper_limit="2819.5"/>
                    <measurement group_id="O2" value="1819.8" lower_limit="1300.2" upper_limit="2547.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 19F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1039.4" lower_limit="646.0" upper_limit="1672.2"/>
                    <measurement group_id="O2" value="640.4" lower_limit="378.1" upper_limit="1084.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 22F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="116.4" lower_limit="54.9" upper_limit="246.8"/>
                    <measurement group_id="O2" value="30.9" lower_limit="16.6" upper_limit="57.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 23F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1245.8" lower_limit="656.9" upper_limit="2362.5"/>
                    <measurement group_id="O2" value="779.8" lower_limit="414.3" upper_limit="1467.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 33F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1515.4" lower_limit="914.3" upper_limit="2511.5"/>
                    <measurement group_id="O2" value="1984.0" lower_limit="1207.9" upper_limit="3259.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F at Week 26</title>
        <description>Vaccine-induced functional antibodies were measured by the MOPA-4 assay, which is based on the ability of antibody in the serum to initiate killing of bacterial pneumococci.</description>
        <time_frame>Week 26</time_frame>
        <population>All randomized participants who received at least 1 vaccination and provided serology data for the particular serotype tested; with appropriate day ranges for vaccinations and blood draws, and excludes participants with important deviations from the protocol that may substantially affect the results.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo</title>
            <description>Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Pneumovax™ 23 0.5 mL intramuscular injection at Week 8, and Placebo 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23</title>
            <description>Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Placebo 0.5 mL intramuscular injection at Week 8, and Pneumovax™ 23 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F at Week 26</title>
          <description>Vaccine-induced functional antibodies were measured by the MOPA-4 assay, which is based on the ability of antibody in the serum to initiate killing of bacterial pneumococci.</description>
          <population>All randomized participants who received at least 1 vaccination and provided serology data for the particular serotype tested; with appropriate day ranges for vaccinations and blood draws, and excludes participants with important deviations from the protocol that may substantially affect the results.</population>
          <units>Titer</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="44"/>
                <count group_id="O2" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serotype 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.7" lower_limit="20.4" upper_limit="77.4"/>
                    <measurement group_id="O2" value="18.9" lower_limit="10.7" upper_limit="33.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.6" lower_limit="12.0" upper_limit="32.1"/>
                    <measurement group_id="O2" value="9.2" lower_limit="6.2" upper_limit="13.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="737.1" lower_limit="451.9" upper_limit="1202.1"/>
                    <measurement group_id="O2" value="788.4" lower_limit="535.3" upper_limit="1161.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="114.4" lower_limit="58.5" upper_limit="223.4"/>
                    <measurement group_id="O2" value="65.6" lower_limit="36.2" upper_limit="118.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 6A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1843.2" lower_limit="1111.0" upper_limit="3057.8"/>
                    <measurement group_id="O2" value="1152.9" lower_limit="655.0" upper_limit="2029.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 6B</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="44"/>
                    <count group_id="O2" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1157.0" lower_limit="639.0" upper_limit="2094.7"/>
                    <measurement group_id="O2" value="1125.1" lower_limit="689.7" upper_limit="1835.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 7F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="44"/>
                    <count group_id="O2" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1204.9" lower_limit="832.1" upper_limit="1744.8"/>
                    <measurement group_id="O2" value="770.7" lower_limit="499.5" upper_limit="1189.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 9V</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="698.2" lower_limit="437.7" upper_limit="1113.8"/>
                    <measurement group_id="O2" value="806.5" lower_limit="500.9" upper_limit="1298.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1458.2" lower_limit="949.2" upper_limit="2240.1"/>
                    <measurement group_id="O2" value="1373.9" lower_limit="879.5" upper_limit="2146.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 18C</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="44"/>
                    <count group_id="O2" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="914.2" lower_limit="594.3" upper_limit="1406.2"/>
                    <measurement group_id="O2" value="691.1" lower_limit="383.1" upper_limit="1246.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 19A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1024.3" lower_limit="749.4" upper_limit="1400.1"/>
                    <measurement group_id="O2" value="806.3" lower_limit="539.3" upper_limit="1205.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 19F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="563.7" lower_limit="344.0" upper_limit="923.7"/>
                    <measurement group_id="O2" value="228.9" lower_limit="126.1" upper_limit="415.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 22F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1228.3" lower_limit="733.3" upper_limit="2057.4"/>
                    <measurement group_id="O2" value="45.2" lower_limit="23.5" upper_limit="86.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 23F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="653.8" lower_limit="315.8" upper_limit="1353.4"/>
                    <measurement group_id="O2" value="366.6" lower_limit="195.9" upper_limit="685.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 33F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="44"/>
                    <count group_id="O2" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4672.8" lower_limit="2968.8" upper_limit="7354.7"/>
                    <measurement group_id="O2" value="1151.4" lower_limit="660.4" upper_limit="2007.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F at Week 30</title>
        <description>Vaccine-induced functional antibodies were measured by the MOPA-4 assay, which is based on the ability of antibody in the serum to initiate killing of bacterial pneumococci.</description>
        <time_frame>Week 30</time_frame>
        <population>All randomized participants who received at least 1 vaccination and provided serology data for the particular serotype tested; with appropriate day ranges for vaccinations and blood draws, and excludes participants with important deviations from the protocol that may substantially affect the results.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo</title>
            <description>Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Pneumovax™ 23 0.5 mL intramuscular injection at Week 8, and Placebo 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23</title>
            <description>Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Placebo 0.5 mL intramuscular injection at Week 8, and Pneumovax™ 23 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F at Week 30</title>
          <description>Vaccine-induced functional antibodies were measured by the MOPA-4 assay, which is based on the ability of antibody in the serum to initiate killing of bacterial pneumococci.</description>
          <population>All randomized participants who received at least 1 vaccination and provided serology data for the particular serotype tested; with appropriate day ranges for vaccinations and blood draws, and excludes participants with important deviations from the protocol that may substantially affect the results.</population>
          <units>Titer</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="88"/>
                <count group_id="O2" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serotype 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="89"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.0" lower_limit="23.2" upper_limit="55.9"/>
                    <measurement group_id="O2" value="43.4" lower_limit="28.8" upper_limit="65.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                    <count group_id="O2" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.9" lower_limit="10.2" upper_limit="18.9"/>
                    <measurement group_id="O2" value="32.8" lower_limit="23.8" upper_limit="45.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="87"/>
                    <count group_id="O2" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="803.6" lower_limit="601.2" upper_limit="1074.2"/>
                    <measurement group_id="O2" value="1060.0" lower_limit="796.2" upper_limit="1411.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="87"/>
                    <count group_id="O2" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.5" lower_limit="51.1" upper_limit="130.0"/>
                    <measurement group_id="O2" value="117.3" lower_limit="83.5" upper_limit="164.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 6A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="91"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1673.9" lower_limit="1141.5" upper_limit="2454.5"/>
                    <measurement group_id="O2" value="1782.7" lower_limit="1255.1" upper_limit="2532.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 6B</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1330.3" lower_limit="911.8" upper_limit="1940.8"/>
                    <measurement group_id="O2" value="1343.6" lower_limit="993.3" upper_limit="1817.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 7F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="87"/>
                    <count group_id="O2" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="877.7" lower_limit="683.3" upper_limit="1127.5"/>
                    <measurement group_id="O2" value="1248.4" lower_limit="955.3" upper_limit="1631.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 9V</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="87"/>
                    <count group_id="O2" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="628.9" lower_limit="444.3" upper_limit="890.4"/>
                    <measurement group_id="O2" value="1134.8" lower_limit="841.4" upper_limit="1530.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="87"/>
                    <count group_id="O2" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1762.9" lower_limit="1257.3" upper_limit="2471.7"/>
                    <measurement group_id="O2" value="1963.3" lower_limit="1441.9" upper_limit="2673.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 18C</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="779.3" lower_limit="582.9" upper_limit="1041.8"/>
                    <measurement group_id="O2" value="1125.6" lower_limit="843.5" upper_limit="1502.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 19A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="87"/>
                    <count group_id="O2" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="845.5" lower_limit="649.5" upper_limit="1100.6"/>
                    <measurement group_id="O2" value="1256.1" lower_limit="1027.9" upper_limit="1535.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 19F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="349.1" lower_limit="236.9" upper_limit="514.5"/>
                    <measurement group_id="O2" value="880.8" lower_limit="663.9" upper_limit="1168.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 22F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1124.7" lower_limit="751.7" upper_limit="1682.9"/>
                    <measurement group_id="O2" value="982.1" lower_limit="642.6" upper_limit="1501.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 23F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="574.3" lower_limit="367.6" upper_limit="897.2"/>
                    <measurement group_id="O2" value="755.6" lower_limit="521.6" upper_limit="1094.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 33F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5917.9" lower_limit="4199.6" upper_limit="8339.4"/>
                    <measurement group_id="O2" value="7853.5" lower_limit="5521.3" upper_limit="11171.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 30 Weeks</time_frame>
      <desc>Participants who received at least 1 dose of study intervention. Adverse Events, including injection specific Adverse Events, were pre-specified to be monitored/assessed per vaccination sequence group, and are therefore reported per vaccination sequence group..</desc>
      <group_list>
        <group group_id="E1">
          <title>Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo</title>
          <description>Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Pneumovax™ 23 0.5 mL intramuscular injection at Week 8, and Placebo 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.</description>
        </group>
        <group group_id="E2">
          <title>Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23</title>
          <description>Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Placebo 0.5 mL intramuscular injection at Week 8, and Pneumovax™ 23 0.5 mL intramuscular injection at Week 26. Injections were administered in alternating limbs.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 18.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="200"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>Colitis ulcerative</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>Gastrointestinal neoplasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>Urethral cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>Bowen's disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>Glioblastoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>Brain injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 18.1</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="177" subjects_at_risk="200"/>
                <counts group_id="E2" subjects_affected="165" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="209" subjects_affected="100" subjects_at_risk="200"/>
                <counts group_id="E2" events="159" subjects_affected="89" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" events="138" subjects_affected="99" subjects_at_risk="200"/>
                <counts group_id="E2" events="93" subjects_affected="72" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" events="357" subjects_affected="168" subjects_at_risk="200"/>
                <counts group_id="E2" events="289" subjects_affected="151" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>Injection site swelling</sub_title>
                <counts group_id="E1" events="173" subjects_affected="111" subjects_at_risk="200"/>
                <counts group_id="E2" events="111" subjects_affected="78" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="105" subjects_affected="58" subjects_at_risk="200"/>
                <counts group_id="E2" events="80" subjects_affected="55" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="210" subjects_affected="123" subjects_at_risk="200"/>
                <counts group_id="E2" events="184" subjects_affected="115" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="140" subjects_affected="78" subjects_at_risk="200"/>
                <counts group_id="E2" events="114" subjects_affected="60" subjects_at_risk="200"/>
              </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 Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.</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/NCT02225587
org study id: V110-029
secondary id: 2013-003027-11
secondary id: V110-029
nct id: NCT02225587
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate the safety and immunogenicity of sequential
      administration of Prevnar 13™ and Pneumovax™ 23 in healthy participants 50 years of age and
      older. The primary hypotheses in the study are that 1) geometric mean titers (GMTs) to
      pneumococcal serotypes 22F and 33F (serotypes in Pneumovax™ 23 but not in Prevnar 13™) as
      measured at Week 12 are superior in participants administered Prevnar 13™ on Day 1 and
      Pneumovax™ 23 at Week 8, as compared with participants administered Prevnar 13™ on Day 1 and
      placebo at Week 8 and 2) GMTs to pneumococcal serotypes shared by the two vaccines as
      measured at Week 12 are non-inferior in participants administered Prevnar 13™ followed by
      Pneumovax™ 23 as compared with participants administered Prevnar 13™ followed by placebo.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Percentage of Participants With an Adverse Event (AE)
time frame: Up to 14 days after any vaccination (Up to 28 weeks)
description: An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
measure: Percentage of Participants With an Injection-site Adverse Event
time frame: Up to 14 days after any vaccination (Up to 28 weeks)
description: An injection site adverse event (AE) includes the following AEs at the injection site: redness, swelling, and pain/tenderness.
measure: Percentage of Participants With a Systemic Adverse Event
time frame: Up to 14 days after any vaccination (Up to 28 weeks)
description: Systemic adverse events (AEs) include, but are not restricted to the following AE terms: muscle pain, joint pain, headache, and tiredness.
measure: Percentage of Participants With a Serious Adverse Event (SAE)
time frame: Up to 30 weeks
description: A serious adverse event (SAE) is any adverse event occurring at any dose or during any use of Sponsor's product that: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is another important medical event; is a cancer; or is associated with an overdose.
measure: Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE) or Vaccine-related Death
time frame: Up to 30 weeks
description: A serious adverse event (SAE) is any adverse event occurring at any dose or during any use of Sponsor's product that: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is another important medical event; is a cancer; or is associated with an overdose. The investigator determined whether the SAE or death was related to vaccine treatment.
measure: Percentage of Participants Who Discontinued Vaccination Due to an Adverse Event
time frame: Up to 26 weeks
description: An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
measure: Geometric Mean Titers to Pneumococcal Serotypes 22F and 33F at Week 12
time frame: Week 12
description: Vaccine-induced functional antibodies to serotypes 22F and 33F, which are unique to PNEUMOVAX™ 23, were measured by the multiplex opsonophagocytic activity 4 (MOPA-4) assay, which is based on the ability of antibody in the serum to initiate killing of bacterial pneumococci.
measure: Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, at Week 12
time frame: Week 12
description: Vaccine-induced functional antibodies to serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, which are contained in both Prevnar 13™ and PNEUMOVAX™ 23, were measured by the MOPA-4 assay, which is based on the ability of antibody in the serum to initiate killing of bacterial pneumococci.
measure: Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F at Week 8
time frame: Week 8
description: Vaccine-induced functional antibodies were measured by the MOPA-4 assay, which is based on the ability of antibody in the serum to initiate killing of bacterial pneumococci.
measure: Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F at Week 26
time frame: Week 26
description: Vaccine-induced functional antibodies were measured by the MOPA-4 assay, which is based on the ability of antibody in the serum to initiate killing of bacterial pneumococci.
measure: Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F at Week 30
time frame: Week 30
description: Vaccine-induced functional antibodies were measured by the MOPA-4 assay, which is based on the ability of antibody in the serum to initiate killing of bacterial pneumococci.
arm group label: Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo
arm group type: Experimental
description: Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Pneumovax™ 23 0.5 mL intramuscular injection at Week 8, and Placebo 0.5 mL intramuscular injection at Week 26. Injections are to be administered in alternating limbs, if possible.
arm group label: Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23
arm group type: Placebo Comparator
description: Prevnar 13™ 0.5 mL intramuscular injection on Day 1, Placebo 0.5 mL intramuscular injection at Week 8, and Pneumovax™ 23 0.5 mL intramuscular injection at Week 26. Injections are to be administered in alternating limbs, if possible.
intervention type: Biological
intervention name: Prevnar 13™
description: Pneumococcal vaccine containing serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. Injections are to be administered into the deltoid muscle of the upper arm.
arm group label: Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo
arm group label: Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23
intervention type: Biological
intervention name: Pneumovax™ 23
description: Pneumococcal vaccine containing serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F. Injections are to be administered into the deltoid muscle of the upper arm.
arm group label: Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo
arm group label: Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23
intervention type: Biological
intervention name: Placebo
description: Injections are to be administered into the deltoid muscle of the upper arm.
arm group label: Group 1: Prevnar 13™ → Pneumovax™ 23 → Placebo
arm group label: Group 2: Prevnar 13™ → Placebo → Pneumovax™ 23
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Medical Director
role: Study Director
affiliation: Merck Sharp & Dohme LLC
country: United States
citation: Buchwald UK, Andrews CP, Ervin J, Peterson JT, Tamms GM, Krupa D, Ajiboye P, Roalfe L, Krick AL, Sterling TM, Wang M, Martin JC, Stek JE, Kohn MA, Folaranmi T, Abeygunawardana C, Hartzel J, Musey LK; V110-029 Study Group. Sequential administration of Prevnar 13 and PNEUMOVAX 23 in healthy participants 50 years of age and older. Hum Vaccin Immunother. 2021 Aug 3;17(8):2678-2690. doi: 10.1080/21645515.2021.1888621. Epub 2021 May 21.
PMID: 34019468
responsible party type: Sponsor
mesh term: Pneumococcal Infections
mesh term: Heptavalent Pneumococcal Conjugate Vaccine
sharing ipd: Yes
ipd description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
ipd url: http://engagezone.msd.com/ds_documentation.php
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 