<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/NCT03828617</url>
  </required_header>
  <id_info>
    <org_study_id>B7471008</org_study_id>
    <nct_id>NCT03828617</nct_id>
  </id_info>
  <brief_title>Trial to Evaluate the Safety and Immunogenicity of 3 Lots of 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults</brief_title>
  <official_title>A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF 3 LOTS OF 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN PNEUMOCOCCAL VACCINE-NAÏVE ADULTS 18 THROUGH 49 YEARS OF AGE</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This is a Phase 3, randomized, double-blind study with a 4-arm parallel design. Adults 18&#xD;
      through 49 years of age with no history of pneumococcal vaccination will be randomized in a&#xD;
      2:2:2:1 ratio to receive a single dose of: 20vPnC Lot 1; 20vPnC Lot 2; 20vPnC Lot 3; or&#xD;
      13vPnC.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 14, 2019</start_date>
  <completion_date type="Actual">October 9, 2019</completion_date>
  <primary_completion_date type="Actual">October 9, 2019</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 Local Reactions Within 10 Days After Vaccination</measure>
    <time_frame>Within 10 days after vaccination</time_frame>
    <description>Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (greater than [&gt;] 2.0 to 5.0 cm), moderate (&gt;5.0 to 10.0 cm) and severe (&gt;10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity). Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Systemic Events Within 7 Days After Vaccination</measure>
    <time_frame>Within 7 days after vaccination</time_frame>
    <description>Systemic events fever, fatigue, headache, muscle pain, joint pain were recorded by using an electronic diary. Fever was defined as greater than or equal to (&gt;=) 38.0 degree Celsius (C) and categorized to &gt;=38.0 to 38.4 degree C, &gt;38.4 to 38.9 degree C, &gt;38.9 to 40.0 degree C and &gt;40.0 degree C. Fatigue, headache, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily routine activity). Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Any Adverse Events (AEs) Within 1 Month After Vaccination</measure>
    <time_frame>Within 1 month after vaccination</time_frame>
    <description>An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship. Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Any Serious Adverse Events (SAEs) Within 6 Months After Vaccination</measure>
    <time_frame>Within 6 month after vaccination</time_frame>
    <description>An SAE was any untoward medical occurrence at any dose that results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect or that is considered to be an important medical event. Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Any Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination</measure>
    <time_frame>Within 6 months after vaccination</time_frame>
    <description>An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination</measure>
    <time_frame>1 month after vaccination</time_frame>
    <description>OPA titers were determined for serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. OPA titer was expressed as reciprocal of the highest serum dilution. OPA GMTs and 2-sided 95% CIs were calculated. Data for this outcome measure were planned to be analyzed for the 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) only.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination</measure>
    <time_frame>Before vaccination to 1 month after vaccination</time_frame>
    <description>Fold rises are the ratios of the 1 month after vaccination to before vaccination OPA titers. OPA GMFRs from before to 1 month after vaccination were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. Data for this outcome measure was planned to be analyzed for the 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) only.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Greater Than or Equal to (&gt;=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination</measure>
    <time_frame>Before vaccination to 1 month after vaccination</time_frame>
    <description>Percentage of participants with a &gt;=4-fold rise in serotype-specific pneumococcal OPA titers from before vaccination to 1 month after vaccination along with corresponding 2-sided 95% CIs were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. Data for this outcome measure was planned to be analyzed for the 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) only.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (&gt;= LLOQ) at 1 Month After Vaccination</measure>
    <time_frame>1 month after vaccination</time_frame>
    <description>The percentage of participants with OPA titers &gt;=LLOQ were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. Data for this outcome measure was planned to be analyzed for the 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) only.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">1710</enrollment>
  <condition>Pneumococcal Disease</condition>
  <arm_group>
    <arm_group_label>20vPnC Lot 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20vPnC Lot 1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>20vPnC Lot 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20vPnC Lot 2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>20vPnC Lot 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20vPnC Lot 3</description>
  </arm_group>
  <arm_group>
    <arm_group_label>13vPnC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>13vPnC</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>20vPnC</intervention_name>
    <description>20vPnC</description>
    <arm_group_label>20vPnC Lot 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>20vPnC</intervention_name>
    <description>20vPnC</description>
    <arm_group_label>20vPnC Lot 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>20vPnC</intervention_name>
    <description>20vPnC</description>
    <arm_group_label>20vPnC Lot 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>13vPnC</intervention_name>
    <description>Pneumococcal conjugate vaccine</description>
    <arm_group_label>13vPnC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female adults ≥18 and &lt;50 years of age.&#xD;
&#xD;
          2. Adults determined by clinical assessment, including medical history and clinical&#xD;
             judgment, to be eligible for the study, including adults with preexisting stable&#xD;
             disease, defined as disease not requiring significant change in therapy in the&#xD;
             previous 6 weeks or hospitalization for worsening disease within 12 weeks before&#xD;
             receipt of investigational product.&#xD;
&#xD;
          3. Female subject of childbearing potential or male subject who is able to father&#xD;
             children, and willing to use a highly effective method of contraception as outlined in&#xD;
             this protocol for at least 28 days after the dose of investigational product; or&#xD;
             female subject not of childbearing potential or male subject not able to father&#xD;
             children.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous vaccination with any licensed or investigational pneumococcal vaccine, or&#xD;
             planned receipt through study participation.&#xD;
&#xD;
          2. Serious chronic disorder including metastatic malignancy, severe chronic obstructive&#xD;
             pulmonary disease (COPD) requiring supplemental oxygen, end-stage renal disease with&#xD;
             or without dialysis, clinically unstable cardiac disease, or any other disorder that,&#xD;
             in the investigator's opinion, excludes the subject from participating in the study.&#xD;
&#xD;
          3. History of microbiologically proven invasive disease caused by S pneumoniae.&#xD;
&#xD;
          4. Pregnant female subjects or breastfeeding female subjects (known or suspected).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Anaheim Clinical Trials, LLC</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Sacramento</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95815</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente South Sacramento</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95823</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente San Jose</name>
      <address>
        <city>San Jose</city>
        <state>California</state>
        <zip>95119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Santa Clara</name>
      <address>
        <city>Santa Clara</city>
        <state>California</state>
        <zip>95051</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Accel Research Sites - Clinical Research Unit</name>
      <address>
        <city>DeLand</city>
        <state>Florida</state>
        <zip>32720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Centers of America, LLC</name>
      <address>
        <city>Hollywood</city>
        <state>Florida</state>
        <zip>33024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Atlanta</name>
      <address>
        <city>Stockbridge</city>
        <state>Georgia</state>
        <zip>30281</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East West Medical Research Institute</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96814</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heartland Research Associates, LLC</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kentucky Pediatric/Adult Research</name>
      <address>
        <city>Bardstown</city>
        <state>Kentucky</state>
        <zip>40004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridian Clinical Research, LLC</name>
      <address>
        <city>Norfolk</city>
        <state>Nebraska</state>
        <zip>68701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridian Clinical Research, LLC</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rochester Clinical Research, Inc.</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>M3 Wake Research, Inc.</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Wilmington, LLC</name>
      <address>
        <city>Wilmington</city>
        <state>North Carolina</state>
        <zip>28401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Omega Medical Research</name>
      <address>
        <city>Warwick</city>
        <state>Rhode Island</state>
        <zip>02886</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridian Clinical Research, LLC</name>
      <address>
        <city>Dakota Dunes</city>
        <state>South Dakota</state>
        <zip>57049</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Benchmark Research</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>J. Lewis Research, Inc. /Foothill Family Clinic</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>J. Lewis Research, Inc. /Foothill Family Clinic South</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://pmiform.com/clinical-trial-info-request?StudyID=B7471008</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>February 1, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <results_first_submitted>September 21, 2020</results_first_submitted>
  <results_first_submitted_qc>November 3, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">November 4, 2020</results_first_posted>
  <last_update_submitted>November 3, 2020</last_update_submitted>
  <last_update_submitted_qc>November 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2020</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>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.</ipd_description>
    <ipd_url>https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 22, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/17/NCT03828617/Prot_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 11, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/17/NCT03828617/SAP_003.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>A total of 1718 participants were enrolled, out of which only 1710 were randomized. There were 8 participants who were enrolled (signed informed consent document) but were not randomized into the study as the randomization system had reached the pre-specified capacity.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>20vPnC Lot 1</title>
          <description>Participants were randomized to receive a single 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) from Lot 1 on Day 1. Participants were followed up to 6 months after vaccination.</description>
        </group>
        <group group_id="P2">
          <title>20vPnC Lot 2</title>
          <description>Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 2 on Day 1. Participants were followed up to 6 months after vaccination.</description>
        </group>
        <group group_id="P3">
          <title>20vPnC Lot 3</title>
          <description>Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 3 on Day 1. Participants were followed up to 6 months after vaccination.</description>
        </group>
        <group group_id="P4">
          <title>13vPnC</title>
          <description>Participants were randomized to receive a single 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) on Day 1. Participants were followed up to 6 months after vaccination.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="489"/>
                <participants group_id="P2" count="490"/>
                <participants group_id="P3" count="486"/>
                <participants group_id="P4" count="245"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Vaccinated</title>
              <participants_list>
                <participants group_id="P1" count="488"/>
                <participants group_id="P2" count="489"/>
                <participants group_id="P3" count="486"/>
                <participants group_id="P4" count="245"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Population</title>
              <participants_list>
                <participants group_id="P1" count="488"/>
                <participants group_id="P2" count="489"/>
                <participants group_id="P3" count="486"/>
                <participants group_id="P4" count="245"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Evaluable Immunogenicity Population(EIP)</title>
              <participants_list>
                <participants group_id="P1" count="463"/>
                <participants group_id="P2" count="473"/>
                <participants group_id="P3" count="456"/>
                <participants group_id="P4" count="232"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="465"/>
                <participants group_id="P2" count="475"/>
                <participants group_id="P3" count="460"/>
                <participants group_id="P4" count="235"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="26"/>
                <participants group_id="P4" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="23"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No longer met eligibility criteria</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety population included all participants who received 1 dose of any 20vPnC lot or 13vPnC and had safety follow-up after the vaccination.</population>
      <group_list>
        <group group_id="B1">
          <title>20vPnC Lot 1</title>
          <description>Participants were randomized to receive a single 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) from Lot 1 on Day 1. Participants were followed up to 6 months after vaccination.</description>
        </group>
        <group group_id="B2">
          <title>20vPnC Lot 2</title>
          <description>Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 2 on Day 1. Participants were followed up to 6 months after vaccination.</description>
        </group>
        <group group_id="B3">
          <title>20vPnC Lot 3</title>
          <description>Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 3 on Day 1. Participants were followed up to 6 months after vaccination.</description>
        </group>
        <group group_id="B4">
          <title>13vPnC</title>
          <description>Participants were randomized to receive a single 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) on Day 1. Participants were followed up to 6 months after vaccination.</description>
        </group>
        <group group_id="B5">
          <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="488"/>
            <count group_id="B2" value="489"/>
            <count group_id="B3" value="486"/>
            <count group_id="B4" value="245"/>
            <count group_id="B5" value="1708"/>
          </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="35.6" spread="9.17"/>
                    <measurement group_id="B2" value="35.7" spread="9.03"/>
                    <measurement group_id="B3" value="34.9" spread="9.05"/>
                    <measurement group_id="B4" value="35.0" spread="8.70"/>
                    <measurement group_id="B5" value="35.3" spread="9.03"/>
                  </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="331"/>
                    <measurement group_id="B2" value="316"/>
                    <measurement group_id="B3" value="324"/>
                    <measurement group_id="B4" value="144"/>
                    <measurement group_id="B5" value="1115"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="157"/>
                    <measurement group_id="B2" value="173"/>
                    <measurement group_id="B3" value="162"/>
                    <measurement group_id="B4" value="101"/>
                    <measurement group_id="B5" value="593"/>
                  </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="48"/>
                    <measurement group_id="B2" value="58"/>
                    <measurement group_id="B3" value="56"/>
                    <measurement group_id="B4" value="29"/>
                    <measurement group_id="B5" value="191"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="434"/>
                    <measurement group_id="B2" value="427"/>
                    <measurement group_id="B3" value="427"/>
                    <measurement group_id="B4" value="215"/>
                    <measurement group_id="B5" value="1503"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="14"/>
                  </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="5"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="59"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="87"/>
                    <measurement group_id="B2" value="88"/>
                    <measurement group_id="B3" value="97"/>
                    <measurement group_id="B4" value="44"/>
                    <measurement group_id="B5" value="316"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="367"/>
                    <measurement group_id="B2" value="351"/>
                    <measurement group_id="B3" value="350"/>
                    <measurement group_id="B4" value="173"/>
                    <measurement group_id="B5" value="1241"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Local Reactions Within 10 Days After Vaccination</title>
        <description>Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (greater than [&gt;] 2.0 to 5.0 cm), moderate (&gt;5.0 to 10.0 cm) and severe (&gt;10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity). Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.</description>
        <time_frame>Within 10 days after vaccination</time_frame>
        <population>Safety population included all participants who received 1 dose of any 20vPnC lot or 13vPnC and had safety follow-up after the vaccination. Here, &quot;Overall Number of Participants Analyzed&quot; = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled 20vPnC</title>
            <description>Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from any of the lots 1, 2 or 3 on Day 1. Participants were followed up to 6 months after vaccination.</description>
          </group>
          <group group_id="O2">
            <title>13vPnC</title>
            <description>Participants were randomized to receive a single 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) on Day 1. Participants were followed up to 6 months after vaccination.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Local Reactions Within 10 Days After Vaccination</title>
          <description>Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (greater than [&gt;] 2.0 to 5.0 cm), moderate (&gt;5.0 to 10.0 cm) and severe (&gt;10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity). Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.</description>
          <population>Safety population included all participants who received 1 dose of any 20vPnC lot or 13vPnC and had safety follow-up after the vaccination. Here, &quot;Overall Number of Participants Analyzed&quot; = participants evaluable for this outcome measure.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1456"/>
                <count group_id="O2" value="243"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Redness: Any</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.0" lower_limit="5.7" upper_limit="8.4"/>
                    <measurement group_id="O2" value="6.2" lower_limit="3.5" upper_limit="10.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Redness: Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.9" lower_limit="3.0" upper_limit="5.0"/>
                    <measurement group_id="O2" value="3.3" lower_limit="1.4" upper_limit="6.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Redness: Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" lower_limit="1.9" upper_limit="3.6"/>
                    <measurement group_id="O2" value="2.9" lower_limit="1.2" upper_limit="5.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Redness: Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" lower_limit="0.2" upper_limit="1.0"/>
                    <measurement group_id="O2" value="0" lower_limit="0.0" upper_limit="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling: Any</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.5" lower_limit="7.1" upper_limit="10.1"/>
                    <measurement group_id="O2" value="8.6" lower_limit="5.4" upper_limit="12.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling: Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.4" lower_limit="4.3" upper_limit="6.7"/>
                    <measurement group_id="O2" value="5.3" lower_limit="2.9" upper_limit="9.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling: Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" lower_limit="2.1" upper_limit="3.9"/>
                    <measurement group_id="O2" value="3.3" lower_limit="1.4" upper_limit="6.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling: Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" lower_limit="0.0" upper_limit="0.6"/>
                    <measurement group_id="O2" value="0" lower_limit="0.0" upper_limit="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain at the injection site: Any</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.7" lower_limit="76.5" upper_limit="80.8"/>
                    <measurement group_id="O2" value="75.7" lower_limit="69.8" upper_limit="81.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain at the injection site: Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0" lower_limit="47.4" upper_limit="52.6"/>
                    <measurement group_id="O2" value="46.5" lower_limit="40.1" upper_limit="53.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain at the injection site: Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.5" lower_limit="25.3" upper_limit="29.9"/>
                    <measurement group_id="O2" value="27.6" lower_limit="22.1" upper_limit="33.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain at the injection site: Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" lower_limit="0.7" upper_limit="1.9"/>
                    <measurement group_id="O2" value="1.6" lower_limit="0.5" upper_limit="4.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Systemic Events Within 7 Days After Vaccination</title>
        <description>Systemic events fever, fatigue, headache, muscle pain, joint pain were recorded by using an electronic diary. Fever was defined as greater than or equal to (&gt;=) 38.0 degree Celsius (C) and categorized to &gt;=38.0 to 38.4 degree C, &gt;38.4 to 38.9 degree C, &gt;38.9 to 40.0 degree C and &gt;40.0 degree C. Fatigue, headache, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily routine activity). Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.</description>
        <time_frame>Within 7 days after vaccination</time_frame>
        <population>Safety population included all participants who received 1 dose of any 20vPnC lot or 13vPnC and had safety follow-up after the vaccination. Here, &quot;Overall Number of Participants Analyzed&quot; = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled 20vPnC</title>
            <description>Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from any of the lots 1, 2 or 3 on Day 1. Participants were followed up to 6 months after vaccination.</description>
          </group>
          <group group_id="O2">
            <title>13vPnC</title>
            <description>Participants were randomized to receive a single 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) on Day 1. Participants were followed up to 6 months after vaccination.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Systemic Events Within 7 Days After Vaccination</title>
          <description>Systemic events fever, fatigue, headache, muscle pain, joint pain were recorded by using an electronic diary. Fever was defined as greater than or equal to (&gt;=) 38.0 degree Celsius (C) and categorized to &gt;=38.0 to 38.4 degree C, &gt;38.4 to 38.9 degree C, &gt;38.9 to 40.0 degree C and &gt;40.0 degree C. Fatigue, headache, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily routine activity). Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.</description>
          <population>Safety population included all participants who received 1 dose of any 20vPnC lot or 13vPnC and had safety follow-up after the vaccination. Here, &quot;Overall Number of Participants Analyzed&quot; = participants evaluable for this outcome measure.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1456"/>
                <count group_id="O2" value="243"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Fever: &gt;=38.0 degree C (Any)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" lower_limit="0.7" upper_limit="1.9"/>
                    <measurement group_id="O2" value="0.8" lower_limit="0.1" upper_limit="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever: &gt;=38.0 degree C to 38.4 degree C</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" lower_limit="0.4" upper_limit="1.3"/>
                    <measurement group_id="O2" value="0.4" lower_limit="0.0" upper_limit="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever: &gt;38.4 degree C to 38.9 degree C</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" lower_limit="0.1" upper_limit="0.7"/>
                    <measurement group_id="O2" value="0.4" lower_limit="0.0" upper_limit="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever: &gt;38.9 degree C to 40.0 degree C</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" lower_limit="0.0" upper_limit="0.6"/>
                    <measurement group_id="O2" value="0" lower_limit="0.0" upper_limit="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever: &gt;40.0 degree C</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0.0" upper_limit="0.3"/>
                    <measurement group_id="O2" value="0" lower_limit="0.0" upper_limit="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue: Any</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.6" lower_limit="45.0" upper_limit="50.2"/>
                    <measurement group_id="O2" value="43.6" lower_limit="37.3" upper_limit="50.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue: Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.7" lower_limit="22.5" upper_limit="27.0"/>
                    <measurement group_id="O2" value="24.3" lower_limit="19.0" upper_limit="30.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue: Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.2" lower_limit="19.1" upper_limit="23.4"/>
                    <measurement group_id="O2" value="17.7" lower_limit="13.1" upper_limit="23.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue: Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" lower_limit="1.1" upper_limit="2.5"/>
                    <measurement group_id="O2" value="1.6" lower_limit="0.5" upper_limit="4.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache: Any</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.2" lower_limit="33.7" upper_limit="38.7"/>
                    <measurement group_id="O2" value="37.9" lower_limit="31.7" upper_limit="44.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache: Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.6" lower_limit="20.5" upper_limit="24.8"/>
                    <measurement group_id="O2" value="27.2" lower_limit="21.7" upper_limit="33.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache: Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.0" lower_limit="10.4" upper_limit="13.8"/>
                    <measurement group_id="O2" value="9.9" lower_limit="6.4" upper_limit="14.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache: Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" lower_limit="1.0" upper_limit="2.4"/>
                    <measurement group_id="O2" value="0.8" lower_limit="0.1" upper_limit="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Muscle pain: Any</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.1" lower_limit="59.5" upper_limit="64.6"/>
                    <measurement group_id="O2" value="60.5" lower_limit="54.0" upper_limit="66.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Muscle pain: Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.5" lower_limit="36.0" upper_limit="41.0"/>
                    <measurement group_id="O2" value="38.7" lower_limit="32.5" upper_limit="45.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Muscle pain: Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.5" lower_limit="20.4" upper_limit="24.8"/>
                    <measurement group_id="O2" value="19.8" lower_limit="14.9" upper_limit="25.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Muscle pain: Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" lower_limit="0.6" upper_limit="1.8"/>
                    <measurement group_id="O2" value="2.1" lower_limit="0.7" upper_limit="4.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Joint pain: Any</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.8" lower_limit="14.9" upper_limit="18.8"/>
                    <measurement group_id="O2" value="14.0" lower_limit="9.9" upper_limit="19.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Joint pain: Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.0" lower_limit="8.5" upper_limit="11.6"/>
                    <measurement group_id="O2" value="7.8" lower_limit="4.8" upper_limit="11.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Joint pain: Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.5" lower_limit="5.2" upper_limit="7.8"/>
                    <measurement group_id="O2" value="5.3" lower_limit="2.9" upper_limit="9.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Joint pain: Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" lower_limit="0.2" upper_limit="0.9"/>
                    <measurement group_id="O2" value="0.8" lower_limit="0.1" upper_limit="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Any Adverse Events (AEs) Within 1 Month After Vaccination</title>
        <description>An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship. Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.</description>
        <time_frame>Within 1 month after vaccination</time_frame>
        <population>Safety population included all participants who received 1 dose of any 20vPnC lot or 13vPnC and had safety follow-up after the vaccination.</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled 20vPnC</title>
            <description>Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from any of the lots 1, 2 or 3 on Day 1. Participants were followed up to 6 months after vaccination.</description>
          </group>
          <group group_id="O2">
            <title>13vPnC</title>
            <description>Participants were randomized to receive a single 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) on Day 1. Participants were followed up to 6 months after vaccination.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Any Adverse Events (AEs) Within 1 Month After Vaccination</title>
          <description>An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship. Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.</description>
          <population>Safety population included all participants who received 1 dose of any 20vPnC lot or 13vPnC and had safety follow-up after the vaccination.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1463"/>
                <count group_id="O2" value="245"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.8" lower_limit="5.6" upper_limit="8.3"/>
                    <measurement group_id="O2" value="5.3" lower_limit="2.9" upper_limit="8.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Any Serious Adverse Events (SAEs) Within 6 Months After Vaccination</title>
        <description>An SAE was any untoward medical occurrence at any dose that results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect or that is considered to be an important medical event. Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.</description>
        <time_frame>Within 6 month after vaccination</time_frame>
        <population>Safety population includes all participants who received 1 dose of any 20vPnC lot or 13vPnC and had safety follow-up after the vaccination.</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled 20vPnC</title>
            <description>Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from any of the lots 1, 2 or 3 on Day 1. Participants were followed up to 6 months after vaccination.</description>
          </group>
          <group group_id="O2">
            <title>13vPnC</title>
            <description>Participants were randomized to receive a single 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) on Day 1. Participants were followed up to 6 months after vaccination.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Any Serious Adverse Events (SAEs) Within 6 Months After Vaccination</title>
          <description>An SAE was any untoward medical occurrence at any dose that results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect or that is considered to be an important medical event. Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.</description>
          <population>Safety population includes all participants who received 1 dose of any 20vPnC lot or 13vPnC and had safety follow-up after the vaccination.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1463"/>
                <count group_id="O2" value="245"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" lower_limit="0.3" upper_limit="1.3"/>
                    <measurement group_id="O2" value="0" lower_limit="0.0" upper_limit="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Any Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination</title>
        <description>An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.</description>
        <time_frame>Within 6 months after vaccination</time_frame>
        <population>Safety population included all participants who received 1 dose of any 20vPnC lot or 13vPnC and had safety follow-up after the vaccination.</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled 20vPnC</title>
            <description>Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from any of the lots 1, 2 or 3 on Day 1. Participants were followed up to 6 months after vaccination.</description>
          </group>
          <group group_id="O2">
            <title>13vPnC</title>
            <description>Participants were randomized to receive a single 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) on Day 1. Participants were followed up to 6 months after vaccination.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Any Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination</title>
          <description>An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.</description>
          <population>Safety population included all participants who received 1 dose of any 20vPnC lot or 13vPnC and had safety follow-up after the vaccination.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1463"/>
                <count group_id="O2" value="245"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="0.6" upper_limit="1.7"/>
                    <measurement group_id="O2" value="2.0" lower_limit="0.7" upper_limit="4.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination</title>
        <description>OPA titers were determined for serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. OPA titer was expressed as reciprocal of the highest serum dilution. OPA GMTs and 2-sided 95% CIs were calculated. Data for this outcome measure were planned to be analyzed for the 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) only.</description>
        <time_frame>1 month after vaccination</time_frame>
        <population>EIP: participants who received randomized vaccine, had blood collection within 27 to 49 days after vaccination (Visit 2), had at least 1 valid and determinate OPA titer for any serotype at Visit 2, and had no other major protocol deviations. Here, &quot;Number analyzed&quot; = participants evaluable for this outcome measure at specified rows.</population>
        <group_list>
          <group group_id="O1">
            <title>20vPnC Lot 1</title>
            <description>Participants were randomized to receive a single 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) from Lot 1 on Day 1. Participants were followed up to 6 months after vaccination.</description>
          </group>
          <group group_id="O2">
            <title>20vPnC Lot 2</title>
            <description>Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 2 on Day 1. Participants were followed up to 6 months after vaccination.</description>
          </group>
          <group group_id="O3">
            <title>20vPnC Lot 3</title>
            <description>Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 3 on Day 1. Participants were followed up to 6 months after vaccination.</description>
          </group>
        </group_list>
        <measure>
          <title>Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination</title>
          <description>OPA titers were determined for serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. OPA titer was expressed as reciprocal of the highest serum dilution. OPA GMTs and 2-sided 95% CIs were calculated. Data for this outcome measure were planned to be analyzed for the 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) only.</description>
          <population>EIP: participants who received randomized vaccine, had blood collection within 27 to 49 days after vaccination (Visit 2), had at least 1 valid and determinate OPA titer for any serotype at Visit 2, and had no other major protocol deviations. Here, &quot;Number analyzed&quot; = participants evaluable for this outcome measure at specified rows.</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="463"/>
                <count group_id="O2" value="473"/>
                <count group_id="O3" value="456"/>
              </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="462"/>
                    <count group_id="O2" value="470"/>
                    <count group_id="O3" value="454"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="199.5" lower_limit="173.5" upper_limit="229.6"/>
                    <measurement group_id="O2" value="175.1" lower_limit="152.5" upper_limit="201.0"/>
                    <measurement group_id="O3" value="164.6" lower_limit="143.1" upper_limit="189.3"/>
                  </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="458"/>
                    <count group_id="O2" value="469"/>
                    <count group_id="O3" value="451"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.3" lower_limit="42.7" upper_limit="52.4"/>
                    <measurement group_id="O2" value="46.8" lower_limit="42.3" upper_limit="51.8"/>
                    <measurement group_id="O3" value="43.1" lower_limit="38.9" upper_limit="47.8"/>
                  </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="455"/>
                    <count group_id="O2" value="468"/>
                    <count group_id="O3" value="451"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1499.7" lower_limit="1288.3" upper_limit="1745.6"/>
                    <measurement group_id="O2" value="1568.2" lower_limit="1350.2" upper_limit="1821.4"/>
                    <measurement group_id="O3" value="1505.6" lower_limit="1294.4" upper_limit="1751.3"/>
                  </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="457"/>
                    <count group_id="O2" value="466"/>
                    <count group_id="O3" value="450"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="125.8" lower_limit="108.6" upper_limit="145.7"/>
                    <measurement group_id="O2" value="135.6" lower_limit="117.3" upper_limit="156.7"/>
                    <measurement group_id="O3" value="116.8" lower_limit="100.9" upper_limit="135.2"/>
                  </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="454"/>
                    <count group_id="O2" value="468"/>
                    <count group_id="O3" value="446"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4654.1" lower_limit="4033.0" upper_limit="5371.0"/>
                    <measurement group_id="O2" value="3748.3" lower_limit="3255.7" upper_limit="4315.4"/>
                    <measurement group_id="O3" value="3330.4" lower_limit="2885.1" upper_limit="3844.6"/>
                  </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="458"/>
                    <count group_id="O2" value="469"/>
                    <count group_id="O3" value="453"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4403.3" lower_limit="3832.6" upper_limit="5059.0"/>
                    <measurement group_id="O2" value="4349.9" lower_limit="3796.4" upper_limit="4984.1"/>
                    <measurement group_id="O3" value="3907.3" lower_limit="3401.4" upper_limit="4488.3"/>
                  </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="452"/>
                    <count group_id="O2" value="464"/>
                    <count group_id="O3" value="441"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1820.6" lower_limit="1588.5" upper_limit="2086.5"/>
                    <measurement group_id="O2" value="1865.6" lower_limit="1629.7" upper_limit="2135.7"/>
                    <measurement group_id="O3" value="1875.7" lower_limit="1632.6" upper_limit="2154.9"/>
                  </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="454"/>
                    <count group_id="O2" value="467"/>
                    <count group_id="O3" value="446"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5120.4" lower_limit="4464.6" upper_limit="5872.7"/>
                    <measurement group_id="O2" value="4604.1" lower_limit="4024.4" upper_limit="5267.5"/>
                    <measurement group_id="O3" value="4921.7" lower_limit="4292.4" upper_limit="5643.2"/>
                  </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="455"/>
                    <count group_id="O2" value="467"/>
                    <count group_id="O3" value="450"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2240.2" lower_limit="1965.4" upper_limit="2553.5"/>
                    <measurement group_id="O2" value="2091.2" lower_limit="1839.9" upper_limit="2376.8"/>
                    <measurement group_id="O3" value="2001.9" lower_limit="1760.4" upper_limit="2276.5"/>
                  </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="455"/>
                    <count group_id="O2" value="465"/>
                    <count group_id="O3" value="449"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3903.7" lower_limit="3339.6" upper_limit="4563.2"/>
                    <measurement group_id="O2" value="4450.7" lower_limit="3818.1" upper_limit="5188.0"/>
                    <measurement group_id="O3" value="4221.7" lower_limit="3615.8" upper_limit="4929.2"/>
                  </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="451"/>
                    <count group_id="O2" value="465"/>
                    <count group_id="O3" value="450"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1457.8" lower_limit="1287.5" upper_limit="1650.6"/>
                    <measurement group_id="O2" value="1528.1" lower_limit="1353.2" upper_limit="1725.6"/>
                    <measurement group_id="O3" value="1434.4" lower_limit="1267.8" upper_limit="1623.0"/>
                  </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="455"/>
                    <count group_id="O2" value="466"/>
                    <count group_id="O3" value="452"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="524.5" lower_limit="450.7" upper_limit="610.3"/>
                    <measurement group_id="O2" value="529.2" lower_limit="455.6" upper_limit="614.6"/>
                    <measurement group_id="O3" value="549.0" lower_limit="472.2" upper_limit="638.3"/>
                  </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="459"/>
                    <count group_id="O2" value="471"/>
                    <count group_id="O3" value="454"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1416.1" lower_limit="1182.4" upper_limit="1696.1"/>
                    <measurement group_id="O2" value="1547.5" lower_limit="1294.9" upper_limit="1849.2"/>
                    <measurement group_id="O3" value="1434.6" lower_limit="1197.8" upper_limit="1718.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="435"/>
                    <count group_id="O2" value="448"/>
                    <count group_id="O3" value="436"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1595.0" lower_limit="1402.7" upper_limit="1813.7"/>
                    <measurement group_id="O2" value="1345.9" lower_limit="1185.9" upper_limit="1527.6"/>
                    <measurement group_id="O3" value="1624.3" lower_limit="1430.4" upper_limit="1844.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 10A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="399"/>
                    <count group_id="O2" value="418"/>
                    <count group_id="O3" value="410"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6328.1" lower_limit="5407.7" upper_limit="7405.2"/>
                    <measurement group_id="O2" value="5692.6" lower_limit="4890.2" upper_limit="6626.6"/>
                    <measurement group_id="O3" value="5962.2" lower_limit="5121.3" upper_limit="6941.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 11A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="394"/>
                    <count group_id="O2" value="399"/>
                    <count group_id="O3" value="399"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8656.2" lower_limit="7308.4" upper_limit="10252.5"/>
                    <measurement group_id="O2" value="6728.5" lower_limit="5693.2" upper_limit="7952.0"/>
                    <measurement group_id="O3" value="8720.3" lower_limit="7408.6" upper_limit="10264.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 12F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="418"/>
                    <count group_id="O2" value="418"/>
                    <count group_id="O3" value="411"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8563.0" lower_limit="7321.5" upper_limit="10015.0"/>
                    <measurement group_id="O2" value="7907.5" lower_limit="6764.8" upper_limit="9243.3"/>
                    <measurement group_id="O3" value="7412.4" lower_limit="6331.8" upper_limit="8677.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 15B</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="392"/>
                    <count group_id="O2" value="426"/>
                    <count group_id="O3" value="402"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7342.8" lower_limit="6108.1" upper_limit="8827.2"/>
                    <measurement group_id="O2" value="6356.9" lower_limit="5325.0" upper_limit="7588.7"/>
                    <measurement group_id="O3" value="7018.9" lower_limit="5853.8" upper_limit="8416.1"/>
                  </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="367"/>
                    <count group_id="O2" value="392"/>
                    <count group_id="O3" value="384"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12507.5" lower_limit="10318.3" upper_limit="15161.1"/>
                    <measurement group_id="O2" value="11213.4" lower_limit="9337.1" upper_limit="13466.9"/>
                    <measurement group_id="O3" value="12728.6" lower_limit="10571.7" upper_limit="15325.5"/>
                  </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="391"/>
                    <count group_id="O2" value="401"/>
                    <count group_id="O3" value="409"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10745.7" lower_limit="9042.0" upper_limit="12770.5"/>
                    <measurement group_id="O2" value="10328.2" lower_limit="8737.0" upper_limit="12209.3"/>
                    <measurement group_id="O3" value="10418.2" lower_limit="8815.3" upper_limit="12312.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serotype 1: Geometric mean ratios (GMRs) (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% confidence intervals (CIs).</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio (GMR)</param_type>
            <param_value>1.14</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.95</ci_lower_limit>
            <ci_upper_limit>1.37</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serotype 3: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio (GMR)</param_type>
            <param_value>1.01</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.88</ci_lower_limit>
            <ci_upper_limit>1.16</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serotype 4: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>0.96</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.78</ci_lower_limit>
            <ci_upper_limit>1.17</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serotype 5: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>0.93</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.77</ci_lower_limit>
            <ci_upper_limit>1.12</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serotype 6A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>1.24</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.03</ci_lower_limit>
            <ci_upper_limit>1.50</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serotype 6B: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>1.01</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.85</ci_lower_limit>
            <ci_upper_limit>1.21</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serotype 7F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>0.98</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.82</ci_lower_limit>
            <ci_upper_limit>1.17</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serotype 9V: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>1.11</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.93</ci_lower_limit>
            <ci_upper_limit>1.33</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serotype 14: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>1.07</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.90</ci_lower_limit>
            <ci_upper_limit>1.27</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serotype 18C: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>0.88</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.72</ci_lower_limit>
            <ci_upper_limit>1.07</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serotype 19A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>0.95</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.81</ci_lower_limit>
            <ci_upper_limit>1.12</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serotype 19F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>0.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.81</ci_lower_limit>
            <ci_upper_limit>1.21</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serotype 23F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>0.92</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.72</ci_lower_limit>
            <ci_upper_limit>1.16</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serotype 8: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>1.19</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.00</ci_lower_limit>
            <ci_upper_limit>1.40</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serotype 10A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>1.11</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.91</ci_lower_limit>
            <ci_upper_limit>1.36</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serotype 11A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>1.29</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.03</ci_lower_limit>
            <ci_upper_limit>1.60</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serotype 12F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>1.08</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.88</ci_lower_limit>
            <ci_upper_limit>1.33</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serotype 15B: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>1.16</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.91</ci_lower_limit>
            <ci_upper_limit>1.46</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serotype 22F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>1.12</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.87</ci_lower_limit>
            <ci_upper_limit>1.43</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Serotype 33F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>1.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.83</ci_lower_limit>
            <ci_upper_limit>1.30</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Serotype 1: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>1.21</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.01</ci_lower_limit>
            <ci_upper_limit>1.46</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Serotype 3: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>1.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.96</ci_lower_limit>
            <ci_upper_limit>1.26</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Serotype 4: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>1.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.82</ci_lower_limit>
            <ci_upper_limit>1.22</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Serotype 5: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>1.08</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.89</ci_lower_limit>
            <ci_upper_limit>1.31</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Serotype 6A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>1.40</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.16</ci_lower_limit>
            <ci_upper_limit>1.69</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Serotype 6B: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>1.13</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.94</ci_lower_limit>
            <ci_upper_limit>1.35</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Serotype 7F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>0.97</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.81</ci_lower_limit>
            <ci_upper_limit>1.16</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Serotype 9V: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>1.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.87</ci_lower_limit>
            <ci_upper_limit>1.25</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Serotype 14: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>1.12</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.94</ci_lower_limit>
            <ci_upper_limit>1.33</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Serotype 18C: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>0.92</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.75</ci_lower_limit>
            <ci_upper_limit>1.13</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Serotype 19A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>1.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.86</ci_lower_limit>
            <ci_upper_limit>1.20</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Serotype 19F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>0.96</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.78</ci_lower_limit>
            <ci_upper_limit>1.17</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Serotype 23F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>0.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.78</ci_lower_limit>
            <ci_upper_limit>1.25</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Serotype 8: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>0.98</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.83</ci_lower_limit>
            <ci_upper_limit>1.16</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Serotype 10A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>1.06</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.87</ci_lower_limit>
            <ci_upper_limit>1.30</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Serotype 11A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>0.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.80</ci_lower_limit>
            <ci_upper_limit>1.24</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Serotype 12F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>1.16</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.94</ci_lower_limit>
            <ci_upper_limit>1.42</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Serotype 15B: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>1.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.82</ci_lower_limit>
            <ci_upper_limit>1.33</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Serotype 22F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>0.98</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.77</ci_lower_limit>
            <ci_upper_limit>1.26</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Serotype 33F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>1.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.82</ci_lower_limit>
            <ci_upper_limit>1.29</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Serotype 1: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>1.06</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.89</ci_lower_limit>
            <ci_upper_limit>1.28</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Serotype 3: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>1.09</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.95</ci_lower_limit>
            <ci_upper_limit>1.24</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Serotype 4: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>1.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.85</ci_lower_limit>
            <ci_upper_limit>1.27</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Serotype 5: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>1.16</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.96</ci_lower_limit>
            <ci_upper_limit>1.41</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Serotype 6A: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>1.13</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.93</ci_lower_limit>
            <ci_upper_limit>1.36</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Serotype 6B: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>1.11</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.93</ci_lower_limit>
            <ci_upper_limit>1.33</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Serotype 7F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>0.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.83</ci_lower_limit>
            <ci_upper_limit>1.19</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Serotype 9V: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>0.94</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.78</ci_lower_limit>
            <ci_upper_limit>1.12</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Serotype 14: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>1.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.88</ci_lower_limit>
            <ci_upper_limit>1.24</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Serotype 18C: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>1.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.86</ci_lower_limit>
            <ci_upper_limit>1.29</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Serotype 19A: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>1.07</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.91</ci_lower_limit>
            <ci_upper_limit>1.25</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Serotype 19F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>0.96</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.79</ci_lower_limit>
            <ci_upper_limit>1.17</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Serotype 23F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>1.08</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.85</ci_lower_limit>
            <ci_upper_limit>1.37</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Serotype 8: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>0.83</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.70</ci_lower_limit>
            <ci_upper_limit>0.98</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Serotype 10A: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>0.95</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.78</ci_lower_limit>
            <ci_upper_limit>1.17</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Serotype 11A: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>0.77</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.62</ci_lower_limit>
            <ci_upper_limit>0.96</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Serotype 12F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>1.07</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.87</ci_lower_limit>
            <ci_upper_limit>1.31</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Serotype 15B: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>0.91</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.71</ci_lower_limit>
            <ci_upper_limit>1.15</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Serotype 22F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>0.88</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.69</ci_lower_limit>
            <ci_upper_limit>1.12</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Serotype 33F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>0.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.79</ci_lower_limit>
            <ci_upper_limit>1.24</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination</title>
        <description>Fold rises are the ratios of the 1 month after vaccination to before vaccination OPA titers. OPA GMFRs from before to 1 month after vaccination were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. Data for this outcome measure was planned to be analyzed for the 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) only.</description>
        <time_frame>Before vaccination to 1 month after vaccination</time_frame>
        <population>EIP: participants who received randomized vaccine, had blood collection within 27 to 49 days after vaccination (Visit 2), had at least 1 valid and determinate OPA titer for any serotype at Visit 2, and had no other major protocol deviations. Here, &quot;Number analyzed&quot; = participants evaluable for this outcome measure at specified rows.</population>
        <group_list>
          <group group_id="O1">
            <title>20vPnC Lot 1</title>
            <description>Participants were randomized to receive a single 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) from Lot 1 on Day 1. Participants were followed up to 6 months after vaccination.</description>
          </group>
          <group group_id="O2">
            <title>20vPnC Lot 2</title>
            <description>Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 2 on Day 1. Participants were followed up to 6 months after vaccination.</description>
          </group>
          <group group_id="O3">
            <title>20vPnC Lot 3</title>
            <description>Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 3 on Day 1. Participants were followed up to 6 months after vaccination.</description>
          </group>
        </group_list>
        <measure>
          <title>Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination</title>
          <description>Fold rises are the ratios of the 1 month after vaccination to before vaccination OPA titers. OPA GMFRs from before to 1 month after vaccination were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. Data for this outcome measure was planned to be analyzed for the 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) only.</description>
          <population>EIP: participants who received randomized vaccine, had blood collection within 27 to 49 days after vaccination (Visit 2), had at least 1 valid and determinate OPA titer for any serotype at Visit 2, and had no other major protocol deviations. Here, &quot;Number analyzed&quot; = participants evaluable for this outcome measure at specified rows.</population>
          <units>fold rise</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="463"/>
                <count group_id="O2" value="473"/>
                <count group_id="O3" value="456"/>
              </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="460"/>
                    <count group_id="O2" value="468"/>
                    <count group_id="O3" value="454"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.2" lower_limit="17.6" upper_limit="23.1"/>
                    <measurement group_id="O2" value="17.8" lower_limit="15.6" upper_limit="20.3"/>
                    <measurement group_id="O3" value="17.3" lower_limit="15.0" upper_limit="19.8"/>
                  </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="456"/>
                    <count group_id="O2" value="462"/>
                    <count group_id="O3" value="449"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" lower_limit="4.4" upper_limit="5.5"/>
                    <measurement group_id="O2" value="5.0" lower_limit="4.5" upper_limit="5.5"/>
                    <measurement group_id="O3" value="4.6" lower_limit="4.1" upper_limit="5.1"/>
                  </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="441"/>
                    <count group_id="O2" value="450"/>
                    <count group_id="O3" value="435"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.6" lower_limit="63.8" upper_limit="94.4"/>
                    <measurement group_id="O2" value="94.7" lower_limit="79.4" upper_limit="112.9"/>
                    <measurement group_id="O3" value="81.0" lower_limit="67.0" upper_limit="97.8"/>
                  </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="455"/>
                    <count group_id="O2" value="463"/>
                    <count group_id="O3" value="450"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.7" lower_limit="7.5" upper_limit="10.0"/>
                    <measurement group_id="O2" value="9.4" lower_limit="8.2" upper_limit="10.7"/>
                    <measurement group_id="O3" value="8.0" lower_limit="6.9" upper_limit="9.1"/>
                  </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="436"/>
                    <count group_id="O2" value="451"/>
                    <count group_id="O3" value="429"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="157.2" lower_limit="132.6" upper_limit="186.3"/>
                    <measurement group_id="O2" value="119.6" lower_limit="100.5" upper_limit="142.3"/>
                    <measurement group_id="O3" value="128.4" lower_limit="107.6" upper_limit="153.1"/>
                  </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="423"/>
                    <count group_id="O2" value="442"/>
                    <count group_id="O3" value="424"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.5" lower_limit="59.9" upper_limit="87.8"/>
                    <measurement group_id="O2" value="75.4" lower_limit="62.9" upper_limit="90.4"/>
                    <measurement group_id="O3" value="70.5" lower_limit="58.1" upper_limit="85.6"/>
                  </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="422"/>
                    <count group_id="O2" value="424"/>
                    <count group_id="O3" value="401"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.3" lower_limit="15.5" upper_limit="21.7"/>
                    <measurement group_id="O2" value="19.5" lower_limit="16.5" upper_limit="23.0"/>
                    <measurement group_id="O3" value="19.0" lower_limit="16.1" upper_limit="22.5"/>
                  </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="398"/>
                    <count group_id="O2" value="409"/>
                    <count group_id="O3" value="387"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.4" lower_limit="21.1" upper_limit="30.7"/>
                    <measurement group_id="O2" value="23.3" lower_limit="19.4" upper_limit="27.9"/>
                    <measurement group_id="O3" value="21.6" lower_limit="17.7" upper_limit="26.4"/>
                  </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="426"/>
                    <count group_id="O2" value="436"/>
                    <count group_id="O3" value="434"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.2" lower_limit="14.8" upper_limit="22.3"/>
                    <measurement group_id="O2" value="16.3" lower_limit="13.2" upper_limit="20.0"/>
                    <measurement group_id="O3" value="18.1" lower_limit="14.6" upper_limit="22.3"/>
                  </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="435"/>
                    <count group_id="O2" value="448"/>
                    <count group_id="O3" value="439"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.4" lower_limit="63.9" upper_limit="101.2"/>
                    <measurement group_id="O2" value="95.0" lower_limit="76.6" upper_limit="117.7"/>
                    <measurement group_id="O3" value="79.9" lower_limit="63.8" upper_limit="100.0"/>
                  </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="443"/>
                    <count group_id="O2" value="456"/>
                    <count group_id="O3" value="440"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.9" lower_limit="29.9" upper_limit="43.2"/>
                    <measurement group_id="O2" value="39.1" lower_limit="32.4" upper_limit="47.1"/>
                    <measurement group_id="O3" value="41.8" lower_limit="34.9" upper_limit="50.2"/>
                  </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="450"/>
                    <count group_id="O2" value="458"/>
                    <count group_id="O3" value="448"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.0" lower_limit="12.0" upper_limit="16.5"/>
                    <measurement group_id="O2" value="14.7" lower_limit="12.6" upper_limit="17.2"/>
                    <measurement group_id="O3" value="15.4" lower_limit="13.1" upper_limit="18.0"/>
                  </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="452"/>
                    <count group_id="O2" value="458"/>
                    <count group_id="O3" value="445"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.5" lower_limit="80.4" upper_limit="123.1"/>
                    <measurement group_id="O2" value="125.1" lower_limit="102.4" upper_limit="152.7"/>
                    <measurement group_id="O3" value="120.9" lower_limit="97.9" upper_limit="149.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="416"/>
                    <count group_id="O2" value="429"/>
                    <count group_id="O3" value="418"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.3" lower_limit="31.3" upper_limit="46.8"/>
                    <measurement group_id="O2" value="38.8" lower_limit="32.1" upper_limit="46.9"/>
                    <measurement group_id="O3" value="46.1" lower_limit="37.9" upper_limit="56.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 10A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="350"/>
                    <count group_id="O2" value="368"/>
                    <count group_id="O3" value="370"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.8" lower_limit="16.6" upper_limit="26.1"/>
                    <measurement group_id="O2" value="19.0" lower_limit="15.2" upper_limit="23.7"/>
                    <measurement group_id="O3" value="20.2" lower_limit="15.9" upper_limit="25.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 11A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="319"/>
                    <count group_id="O2" value="321"/>
                    <count group_id="O3" value="332"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.9" lower_limit="5.4" upper_limit="8.9"/>
                    <measurement group_id="O2" value="5.0" lower_limit="3.9" upper_limit="6.4"/>
                    <measurement group_id="O3" value="5.3" lower_limit="4.2" upper_limit="6.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 12F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="390"/>
                    <count group_id="O2" value="389"/>
                    <count group_id="O3" value="376"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="175.5" lower_limit="141.3" upper_limit="217.9"/>
                    <measurement group_id="O2" value="174.6" lower_limit="140.8" upper_limit="216.7"/>
                    <measurement group_id="O3" value="175.7" lower_limit="141.6" upper_limit="218.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 15B</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="364"/>
                    <count group_id="O2" value="395"/>
                    <count group_id="O3" value="369"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="112.5" lower_limit="83.8" upper_limit="150.9"/>
                    <measurement group_id="O2" value="84.2" lower_limit="64.5" upper_limit="110.0"/>
                    <measurement group_id="O3" value="91.7" lower_limit="69.4" upper_limit="121.3"/>
                  </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="322"/>
                    <count group_id="O2" value="357"/>
                    <count group_id="O3" value="338"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.8" lower_limit="59.2" upper_limit="118.6"/>
                    <measurement group_id="O2" value="63.3" lower_limit="46.8" upper_limit="85.7"/>
                    <measurement group_id="O3" value="77.8" lower_limit="56.8" upper_limit="106.6"/>
                  </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="338"/>
                    <count group_id="O2" value="357"/>
                    <count group_id="O3" value="362"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.3" lower_limit="6.7" upper_limit="10.4"/>
                    <measurement group_id="O2" value="8.6" lower_limit="7.0" upper_limit="10.6"/>
                    <measurement group_id="O3" value="7.4" lower_limit="6.0" upper_limit="9.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Greater Than or Equal to (&gt;=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination</title>
        <description>Percentage of participants with a &gt;=4-fold rise in serotype-specific pneumococcal OPA titers from before vaccination to 1 month after vaccination along with corresponding 2-sided 95% CIs were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. Data for this outcome measure was planned to be analyzed for the 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) only.</description>
        <time_frame>Before vaccination to 1 month after vaccination</time_frame>
        <population>EIP: participants who received randomized vaccine, had blood collection within 27 to 49 days after vaccination (Visit 2), had at least 1 valid and determinate OPA titer for any serotype at Visit 2, and had no other major protocol deviations. Here, &quot;Number analyzed&quot; = participants evaluable for this outcome measure at specified rows.</population>
        <group_list>
          <group group_id="O1">
            <title>20vPnC Lot 1</title>
            <description>Participants were randomized to receive a single 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) from Lot 1 on Day 1. Participants were followed up to 6 months after vaccination.</description>
          </group>
          <group group_id="O2">
            <title>20vPnC Lot 2</title>
            <description>Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 2 on Day 1. Participants were followed up to 6 months after vaccination.</description>
          </group>
          <group group_id="O3">
            <title>20vPnC Lot 3</title>
            <description>Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 3 on Day 1. Participants were followed up to 6 months after vaccination.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Greater Than or Equal to (&gt;=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination</title>
          <description>Percentage of participants with a &gt;=4-fold rise in serotype-specific pneumococcal OPA titers from before vaccination to 1 month after vaccination along with corresponding 2-sided 95% CIs were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. Data for this outcome measure was planned to be analyzed for the 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) only.</description>
          <population>EIP: participants who received randomized vaccine, had blood collection within 27 to 49 days after vaccination (Visit 2), had at least 1 valid and determinate OPA titer for any serotype at Visit 2, and had no other major protocol deviations. Here, &quot;Number analyzed&quot; = participants evaluable for this outcome measure at specified rows.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="463"/>
                <count group_id="O2" value="473"/>
                <count group_id="O3" value="456"/>
              </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="460"/>
                    <count group_id="O2" value="468"/>
                    <count group_id="O3" value="454"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.7" lower_limit="80.0" upper_limit="87.0"/>
                    <measurement group_id="O2" value="82.9" lower_limit="79.2" upper_limit="86.2"/>
                    <measurement group_id="O3" value="82.4" lower_limit="78.6" upper_limit="85.8"/>
                  </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="456"/>
                    <count group_id="O2" value="462"/>
                    <count group_id="O3" value="449"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.1" lower_limit="51.4" upper_limit="60.8"/>
                    <measurement group_id="O2" value="57.8" lower_limit="53.1" upper_limit="62.3"/>
                    <measurement group_id="O3" value="53.0" lower_limit="48.3" upper_limit="57.7"/>
                  </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="441"/>
                    <count group_id="O2" value="450"/>
                    <count group_id="O3" value="435"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.0" lower_limit="81.4" upper_limit="88.2"/>
                    <measurement group_id="O2" value="87.6" lower_limit="84.1" upper_limit="90.5"/>
                    <measurement group_id="O3" value="86.2" lower_limit="82.6" upper_limit="89.3"/>
                  </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="455"/>
                    <count group_id="O2" value="463"/>
                    <count group_id="O3" value="450"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.7" lower_limit="61.2" upper_limit="70.1"/>
                    <measurement group_id="O2" value="67.2" lower_limit="62.7" upper_limit="71.4"/>
                    <measurement group_id="O3" value="65.3" lower_limit="60.7" upper_limit="69.7"/>
                  </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="436"/>
                    <count group_id="O2" value="451"/>
                    <count group_id="O3" value="429"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.5" lower_limit="91.9" upper_limit="96.4"/>
                    <measurement group_id="O2" value="93.1" lower_limit="90.4" upper_limit="95.3"/>
                    <measurement group_id="O3" value="93.0" lower_limit="90.2" upper_limit="95.2"/>
                  </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="423"/>
                    <count group_id="O2" value="442"/>
                    <count group_id="O3" value="424"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.3" lower_limit="87.1" upper_limit="93.0"/>
                    <measurement group_id="O2" value="91.4" lower_limit="88.4" upper_limit="93.8"/>
                    <measurement group_id="O3" value="89.2" lower_limit="85.8" upper_limit="91.9"/>
                  </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="422"/>
                    <count group_id="O2" value="424"/>
                    <count group_id="O3" value="401"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.8" lower_limit="72.4" upper_limit="80.7"/>
                    <measurement group_id="O2" value="76.7" lower_limit="72.3" upper_limit="80.6"/>
                    <measurement group_id="O3" value="80.0" lower_limit="75.8" upper_limit="83.9"/>
                  </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="398"/>
                    <count group_id="O2" value="409"/>
                    <count group_id="O3" value="387"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.1" lower_limit="74.8" upper_limit="83.0"/>
                    <measurement group_id="O2" value="79.5" lower_limit="75.2" upper_limit="83.3"/>
                    <measurement group_id="O3" value="75.7" lower_limit="71.1" upper_limit="79.9"/>
                  </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="426"/>
                    <count group_id="O2" value="436"/>
                    <count group_id="O3" value="434"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.0" lower_limit="65.4" upper_limit="74.3"/>
                    <measurement group_id="O2" value="67.7" lower_limit="63.0" upper_limit="72.0"/>
                    <measurement group_id="O3" value="67.7" lower_limit="63.1" upper_limit="72.1"/>
                  </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="435"/>
                    <count group_id="O2" value="448"/>
                    <count group_id="O3" value="439"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.0" lower_limit="79.1" upper_limit="86.4"/>
                    <measurement group_id="O2" value="88.2" lower_limit="84.8" upper_limit="91.0"/>
                    <measurement group_id="O3" value="84.5" lower_limit="80.8" upper_limit="87.8"/>
                  </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="443"/>
                    <count group_id="O2" value="456"/>
                    <count group_id="O3" value="440"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.7" lower_limit="77.8" upper_limit="85.2"/>
                    <measurement group_id="O2" value="81.8" lower_limit="77.9" upper_limit="85.2"/>
                    <measurement group_id="O3" value="85.5" lower_limit="81.8" upper_limit="88.6"/>
                  </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="450"/>
                    <count group_id="O2" value="458"/>
                    <count group_id="O3" value="448"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.0" lower_limit="69.7" upper_limit="78.0"/>
                    <measurement group_id="O2" value="76.2" lower_limit="72.0" upper_limit="80.0"/>
                    <measurement group_id="O3" value="75.2" lower_limit="71.0" upper_limit="79.2"/>
                  </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="452"/>
                    <count group_id="O2" value="458"/>
                    <count group_id="O3" value="445"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.6" lower_limit="82.0" upper_limit="88.7"/>
                    <measurement group_id="O2" value="88.2" lower_limit="84.9" upper_limit="91.0"/>
                    <measurement group_id="O3" value="88.8" lower_limit="85.5" upper_limit="91.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="416"/>
                    <count group_id="O2" value="429"/>
                    <count group_id="O3" value="418"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.0" lower_limit="77.9" upper_limit="85.5"/>
                    <measurement group_id="O2" value="82.3" lower_limit="78.3" upper_limit="85.8"/>
                    <measurement group_id="O3" value="82.5" lower_limit="78.5" upper_limit="86.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 10A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="350"/>
                    <count group_id="O2" value="368"/>
                    <count group_id="O3" value="370"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.9" lower_limit="70.0" upper_limit="79.3"/>
                    <measurement group_id="O2" value="74.5" lower_limit="69.7" upper_limit="78.8"/>
                    <measurement group_id="O3" value="70.8" lower_limit="65.9" upper_limit="75.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 11A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="319"/>
                    <count group_id="O2" value="321"/>
                    <count group_id="O3" value="332"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.4" lower_limit="46.7" upper_limit="57.9"/>
                    <measurement group_id="O2" value="48.0" lower_limit="42.4" upper_limit="53.6"/>
                    <measurement group_id="O3" value="42.2" lower_limit="36.8" upper_limit="47.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 12F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="390"/>
                    <count group_id="O2" value="389"/>
                    <count group_id="O3" value="376"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.8" lower_limit="88.6" upper_limit="94.3"/>
                    <measurement group_id="O2" value="93.1" lower_limit="90.1" upper_limit="95.4"/>
                    <measurement group_id="O3" value="91.5" lower_limit="88.2" upper_limit="94.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 15B</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="364"/>
                    <count group_id="O2" value="395"/>
                    <count group_id="O3" value="369"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.6" lower_limit="77.2" upper_limit="85.4"/>
                    <measurement group_id="O2" value="82.0" lower_limit="77.9" upper_limit="85.7"/>
                    <measurement group_id="O3" value="81.0" lower_limit="76.7" upper_limit="84.9"/>
                  </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="322"/>
                    <count group_id="O2" value="357"/>
                    <count group_id="O3" value="338"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.8" lower_limit="75.0" upper_limit="84.1"/>
                    <measurement group_id="O2" value="82.1" lower_limit="77.7" upper_limit="85.9"/>
                    <measurement group_id="O3" value="81.4" lower_limit="76.8" upper_limit="85.4"/>
                  </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="338"/>
                    <count group_id="O2" value="357"/>
                    <count group_id="O3" value="362"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.7" lower_limit="57.3" upper_limit="67.9"/>
                    <measurement group_id="O2" value="62.7" lower_limit="57.5" upper_limit="67.8"/>
                    <measurement group_id="O3" value="62.7" lower_limit="57.5" upper_limit="67.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (&gt;= LLOQ) at 1 Month After Vaccination</title>
        <description>The percentage of participants with OPA titers &gt;=LLOQ were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. Data for this outcome measure was planned to be analyzed for the 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) only.</description>
        <time_frame>1 month after vaccination</time_frame>
        <population>EIP: participants who received randomized vaccine, had blood collection within 27 to 49 days after vaccination (Visit 2), had at least 1 valid and determinate OPA titer for any serotype at Visit 2, and had no other major protocol deviations. Here, &quot;Number analyzed&quot; = participants evaluable for this outcome measure at specified rows.</population>
        <group_list>
          <group group_id="O1">
            <title>20vPnC Lot 1</title>
            <description>Participants were randomized to receive a single 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal vaccine (20vPnC) from Lot 1 on Day 1. Participants were followed up to 6 months after vaccination.</description>
          </group>
          <group group_id="O2">
            <title>20vPnC Lot 2</title>
            <description>Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 2 on Day 1. Participants were followed up to 6 months after vaccination.</description>
          </group>
          <group group_id="O3">
            <title>20vPnC Lot 3</title>
            <description>Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from Lot 3 on Day 1. Participants were followed up to 6 months after vaccination.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (&gt;= LLOQ) at 1 Month After Vaccination</title>
          <description>The percentage of participants with OPA titers &gt;=LLOQ were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. Data for this outcome measure was planned to be analyzed for the 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) only.</description>
          <population>EIP: participants who received randomized vaccine, had blood collection within 27 to 49 days after vaccination (Visit 2), had at least 1 valid and determinate OPA titer for any serotype at Visit 2, and had no other major protocol deviations. Here, &quot;Number analyzed&quot; = participants evaluable for this outcome measure at specified rows.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="463"/>
                <count group_id="O2" value="473"/>
                <count group_id="O3" value="456"/>
              </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="462"/>
                    <count group_id="O2" value="470"/>
                    <count group_id="O3" value="454"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.8" lower_limit="88.9" upper_limit="94.1"/>
                    <measurement group_id="O2" value="92.8" lower_limit="90.0" upper_limit="94.9"/>
                    <measurement group_id="O3" value="91.0" lower_limit="87.9" upper_limit="93.4"/>
                  </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="458"/>
                    <count group_id="O2" value="469"/>
                    <count group_id="O3" value="451"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.7" lower_limit="86.6" upper_limit="92.4"/>
                    <measurement group_id="O2" value="89.6" lower_limit="86.4" upper_limit="92.2"/>
                    <measurement group_id="O3" value="88.9" lower_limit="85.6" upper_limit="91.7"/>
                  </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="455"/>
                    <count group_id="O2" value="468"/>
                    <count group_id="O3" value="451"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.6" lower_limit="95.7" upper_limit="98.8"/>
                    <measurement group_id="O2" value="97.0" lower_limit="95.0" upper_limit="98.4"/>
                    <measurement group_id="O3" value="97.1" lower_limit="95.1" upper_limit="98.5"/>
                  </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="457"/>
                    <count group_id="O2" value="466"/>
                    <count group_id="O3" value="450"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.3" lower_limit="76.4" upper_limit="83.9"/>
                    <measurement group_id="O2" value="84.3" lower_limit="80.7" upper_limit="87.5"/>
                    <measurement group_id="O3" value="81.3" lower_limit="77.4" upper_limit="84.8"/>
                  </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="454"/>
                    <count group_id="O2" value="468"/>
                    <count group_id="O3" value="446"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.1" lower_limit="97.8" upper_limit="99.8"/>
                    <measurement group_id="O2" value="98.1" lower_limit="96.4" upper_limit="99.1"/>
                    <measurement group_id="O3" value="98.2" lower_limit="96.5" upper_limit="99.2"/>
                  </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="458"/>
                    <count group_id="O2" value="469"/>
                    <count group_id="O3" value="453"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.6" lower_limit="95.7" upper_limit="98.8"/>
                    <measurement group_id="O2" value="99.6" lower_limit="98.5" upper_limit="99.9"/>
                    <measurement group_id="O3" value="98.9" lower_limit="97.4" upper_limit="99.6"/>
                  </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="452"/>
                    <count group_id="O2" value="464"/>
                    <count group_id="O3" value="441"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.7" lower_limit="92.2" upper_limit="96.6"/>
                    <measurement group_id="O2" value="94.0" lower_limit="91.4" upper_limit="96.0"/>
                    <measurement group_id="O3" value="96.6" lower_limit="94.5" upper_limit="98.1"/>
                  </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="454"/>
                    <count group_id="O2" value="467"/>
                    <count group_id="O3" value="446"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.5" lower_limit="96.8" upper_limit="99.4"/>
                    <measurement group_id="O2" value="98.9" lower_limit="97.5" upper_limit="99.7"/>
                    <measurement group_id="O3" value="98.2" lower_limit="96.5" upper_limit="99.2"/>
                  </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="455"/>
                    <count group_id="O2" value="467"/>
                    <count group_id="O3" value="450"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.9" lower_limit="97.5" upper_limit="99.6"/>
                    <measurement group_id="O2" value="99.4" lower_limit="98.1" upper_limit="99.9"/>
                    <measurement group_id="O3" value="97.8" lower_limit="96.0" upper_limit="98.9"/>
                  </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="455"/>
                    <count group_id="O2" value="465"/>
                    <count group_id="O3" value="449"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.9" lower_limit="94.9" upper_limit="98.3"/>
                    <measurement group_id="O2" value="98.1" lower_limit="96.4" upper_limit="99.1"/>
                    <measurement group_id="O3" value="98.7" lower_limit="97.1" upper_limit="99.5"/>
                  </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="451"/>
                    <count group_id="O2" value="465"/>
                    <count group_id="O3" value="450"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.3" lower_limit="98.1" upper_limit="99.9"/>
                    <measurement group_id="O2" value="100.0" lower_limit="99.2" upper_limit="100.0"/>
                    <measurement group_id="O3" value="99.3" lower_limit="98.1" upper_limit="99.9"/>
                  </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="455"/>
                    <count group_id="O2" value="466"/>
                    <count group_id="O3" value="452"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.2" lower_limit="88.2" upper_limit="93.6"/>
                    <measurement group_id="O2" value="91.0" lower_limit="88.0" upper_limit="93.4"/>
                    <measurement group_id="O3" value="90.7" lower_limit="87.6" upper_limit="93.2"/>
                  </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="459"/>
                    <count group_id="O2" value="471"/>
                    <count group_id="O3" value="454"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.3" lower_limit="91.8" upper_limit="96.3"/>
                    <measurement group_id="O2" value="95.8" lower_limit="93.5" upper_limit="97.4"/>
                    <measurement group_id="O3" value="94.9" lower_limit="92.5" upper_limit="96.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="435"/>
                    <count group_id="O2" value="448"/>
                    <count group_id="O3" value="436"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.6" lower_limit="97.0" upper_limit="99.5"/>
                    <measurement group_id="O2" value="99.1" lower_limit="97.7" upper_limit="99.8"/>
                    <measurement group_id="O3" value="99.1" lower_limit="97.7" upper_limit="99.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 10A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="399"/>
                    <count group_id="O2" value="418"/>
                    <count group_id="O3" value="410"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.7" lower_limit="98.6" upper_limit="100.0"/>
                    <measurement group_id="O2" value="99.0" lower_limit="97.6" upper_limit="99.7"/>
                    <measurement group_id="O3" value="99.3" lower_limit="97.9" upper_limit="99.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 11A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="394"/>
                    <count group_id="O2" value="399"/>
                    <count group_id="O3" value="399"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.2" lower_limit="97.8" upper_limit="99.8"/>
                    <measurement group_id="O2" value="99.5" lower_limit="98.2" upper_limit="99.9"/>
                    <measurement group_id="O3" value="99.5" lower_limit="98.2" upper_limit="99.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 12F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="418"/>
                    <count group_id="O2" value="418"/>
                    <count group_id="O3" value="411"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.0" lower_limit="97.6" upper_limit="99.7"/>
                    <measurement group_id="O2" value="99.3" lower_limit="97.9" upper_limit="99.9"/>
                    <measurement group_id="O3" value="99.0" lower_limit="97.5" upper_limit="99.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 15B</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="392"/>
                    <count group_id="O2" value="426"/>
                    <count group_id="O3" value="402"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.0" lower_limit="97.4" upper_limit="99.7"/>
                    <measurement group_id="O2" value="98.6" lower_limit="97.0" upper_limit="99.5"/>
                    <measurement group_id="O3" value="99.3" lower_limit="97.8" upper_limit="99.8"/>
                  </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="367"/>
                    <count group_id="O2" value="392"/>
                    <count group_id="O3" value="384"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.7" lower_limit="98.5" upper_limit="100.0"/>
                    <measurement group_id="O2" value="99.2" lower_limit="97.8" upper_limit="99.8"/>
                    <measurement group_id="O3" value="99.5" lower_limit="98.1" upper_limit="99.9"/>
                  </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="391"/>
                    <count group_id="O2" value="401"/>
                    <count group_id="O3" value="409"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.0" lower_limit="97.4" upper_limit="99.7"/>
                    <measurement group_id="O2" value="98.8" lower_limit="97.1" upper_limit="99.6"/>
                    <measurement group_id="O3" value="98.5" lower_limit="96.8" upper_limit="99.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: up to 1 month after vaccination, SAEs: up to 6 months after vaccination</time_frame>
      <desc>Event may be categorized as serious in 1 participant and non-SAE in another participant or 1 participant may have experienced both SAE and non-SAE. Safety population was used. Because the primary safety objective was to describe the safety profile of 20vPnC and not the safety profile for each lot of 20vPnC,the safety data for 20vPnC in this study are reported as pooled data. The pooled data represent the safety population of 20vPnC in this study and are summarized with the 13vPnC control group.</desc>
      <group_list>
        <group group_id="E1">
          <title>Pooled 20vPnC</title>
          <description>Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC from any of the lots 1, 2 or 3 on Day 1. Participants were followed up to 6 months after vaccination.</description>
        </group>
        <group group_id="E2">
          <title>13vPnC</title>
          <description>Participants were randomized to receive a single 0.5 mL intramuscular injection of 13-valent pneumococcal vaccine (13vPnC) on Day 1. Participants were followed up to 6 months after vaccination.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA v22.1</default_vocab>
        <default_assessment>Non-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="0" subjects_at_risk="1463"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="245"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="1463"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="245"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Splenic cyst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1463"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="245"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1463"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="245"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1463"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="245"/>
              </event>
              <event>
                <sub_title>Hiatus hernia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1463"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="245"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abdominal abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1463"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="245"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1463"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="245"/>
              </event>
              <event>
                <sub_title>Pneumonia mycoplasmal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1463"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="245"/>
              </event>
              <event>
                <sub_title>Staphylococcal bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1463"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="245"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Procedural pneumothorax</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1463"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="245"/>
              </event>
              <event>
                <sub_title>Subcutaneous haematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1463"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="245"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic ketoacidosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1463"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="245"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1463"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="245"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1463"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="245"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin necrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1463"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="245"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_vocab>MedDRA v22.1</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="1275" subjects_at_risk="1463"/>
                <counts group_id="E2" subjects_affected="206" subjects_at_risk="245"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="693" subjects_at_risk="1463"/>
                <counts group_id="E2" subjects_affected="106" subjects_at_risk="245"/>
              </event>
              <event>
                <sub_title>Injection site erythema (REDNESS)</sub_title>
                <counts group_id="E1" subjects_affected="102" subjects_at_risk="1463"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="245"/>
              </event>
              <event>
                <sub_title>Injection site pain (PAIN)</sub_title>
                <counts group_id="E1" subjects_affected="1146" subjects_at_risk="1463"/>
                <counts group_id="E2" subjects_affected="184" subjects_at_risk="245"/>
              </event>
              <event>
                <sub_title>Injection site swelling (SWELLING)</sub_title>
                <counts group_id="E1" subjects_affected="124" subjects_at_risk="1463"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="245"/>
              </event>
              <event>
                <sub_title>Pyrexia (FEVER)</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="1463"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="245"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia (JOINT PAIN)</sub_title>
                <counts group_id="E1" subjects_affected="245" subjects_at_risk="1463"/>
                <counts group_id="E2" subjects_affected="34" subjects_at_risk="245"/>
              </event>
              <event>
                <sub_title>Myalgia (MUSCLE PAIN)</sub_title>
                <counts group_id="E1" subjects_affected="904" subjects_at_risk="1463"/>
                <counts group_id="E2" subjects_affected="147" subjects_at_risk="245"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="527" subjects_at_risk="1463"/>
                <counts group_id="E2" subjects_affected="92" subjects_at_risk="245"/>
              </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>Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Pfizer ClinicalTrials.gov Call Center</name_or_title>
      <organization>Pfizer Inc.</organization>
      <phone>1-800-718-1021</phone>
      <email>ClinicalTrials.gov_Inquiries@pfizer.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/NCT03828617
org study id: B7471008
nct id: NCT03828617
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a Phase 3, randomized, double-blind study with a 4-arm parallel design. Adults 18
      through 49 years of age with no history of pneumococcal vaccination will be randomized in a
      2:2:2:1 ratio to receive a single dose of: 20vPnC Lot 1; 20vPnC Lot 2; 20vPnC Lot 3; or
      13vPnC.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Percentage of Participants With Local Reactions Within 10 Days After Vaccination
time frame: Within 10 days after vaccination
description: Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (greater than [>] 2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm) and severe (>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity). Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.
measure: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
time frame: Within 7 days after vaccination
description: Systemic events fever, fatigue, headache, muscle pain, joint pain were recorded by using an electronic diary. Fever was defined as greater than or equal to (>=) 38.0 degree Celsius (C) and categorized to >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree C. Fatigue, headache, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily routine activity). Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.
measure: Percentage of Participants With Any Adverse Events (AEs) Within 1 Month After Vaccination
time frame: Within 1 month after vaccination
description: An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship. Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.
measure: Percentage of Participants With Any Serious Adverse Events (SAEs) Within 6 Months After Vaccination
time frame: Within 6 month after vaccination
description: An SAE was any untoward medical occurrence at any dose that results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect or that is considered to be an important medical event. Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.
measure: Percentage of Participants With Any Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination
time frame: Within 6 months after vaccination
description: An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.
measure: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
time frame: 1 month after vaccination
description: OPA titers were determined for serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. OPA titer was expressed as reciprocal of the highest serum dilution. OPA GMTs and 2-sided 95% CIs were calculated. Data for this outcome measure were planned to be analyzed for the 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) only.
measure: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
time frame: Before vaccination to 1 month after vaccination
description: Fold rises are the ratios of the 1 month after vaccination to before vaccination OPA titers. OPA GMFRs from before to 1 month after vaccination were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. Data for this outcome measure was planned to be analyzed for the 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) only.
measure: Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination
time frame: Before vaccination to 1 month after vaccination
description: Percentage of participants with a >=4-fold rise in serotype-specific pneumococcal OPA titers from before vaccination to 1 month after vaccination along with corresponding 2-sided 95% CIs were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. Data for this outcome measure was planned to be analyzed for the 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) only.
measure: Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination
time frame: 1 month after vaccination
description: The percentage of participants with OPA titers >=LLOQ were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. Data for this outcome measure was planned to be analyzed for the 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) only.
arm group label: 20vPnC Lot 1
arm group type: Experimental
description: 20vPnC Lot 1
arm group label: 20vPnC Lot 2
arm group type: Experimental
description: 20vPnC Lot 2
arm group label: 20vPnC Lot 3
arm group type: Experimental
description: 20vPnC Lot 3
arm group label: 13vPnC
arm group type: Active Comparator
description: 13vPnC
intervention type: Biological
intervention name: 20vPnC
description: 20vPnC
arm group label: 20vPnC Lot 1
intervention type: Biological
intervention name: 20vPnC
description: 20vPnC
arm group label: 20vPnC Lot 2
intervention type: Biological
intervention name: 20vPnC
description: 20vPnC
arm group label: 20vPnC Lot 3
intervention type: Biological
intervention name: 13vPnC
description: Pneumococcal conjugate vaccine
arm group label: 13vPnC
criteria: 
gender: All
minimum age: 18 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
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country: United States
url: https://pmiform.com/clinical-trial-info-request?StudyID=B7471008
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Pneumococcal Infections
sharing ipd: Yes
ipd description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
ipd url: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
provided document: 
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participant flow: 
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outcome list: 
reported events: 
certain agreements: 
point of contact: 