<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/NCT02987972</url>
  </required_header>
  <id_info>
    <org_study_id>V114-008</org_study_id>
    <secondary_id>2016-001117-25</secondary_id>
    <nct_id>NCT02987972</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Two Lots of V114 in Healthy Infants (V114-008)</brief_title>
  <official_title>A Phase II, Double-Blind, Randomized, Multicenter Trial to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in Healthy Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Merck Sharp &amp; Dohme LLC</source>
  <oversight_info>
    <has_dmc>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 study is designed to evaluate the safety, tolerability, and immunogenicity of two&#xD;
      different lots of V114 in healthy infants 6 to 12 weeks (&gt;=42 days to &lt;=90 days) of age. The&#xD;
      primary hypothesis of the study is that the proportion of participants receiving V114 who&#xD;
      have serotype specific IgG &gt;=0.35 mcg/mL for each of pneumococcal serotypes 1, 3, 4, 5, 6A,&#xD;
      6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F at 1 month after Dose 3 is non-inferior to that for&#xD;
      recipients of Prevnar 13™.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 21, 2017</start_date>
  <completion_date type="Actual">October 4, 2018</completion_date>
  <primary_completion_date type="Actual">October 4, 2018</primary_completion_date>
  <phase>Phase 2</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3</measure>
    <time_frame>1 month post vaccination 3 (Month 5)</time_frame>
    <description>Serotype-specific pneumococcal IgG antibody was measured using the Meso-Scale Discovery (MSD) Pneumococcal electrochemiluminescence assay (Pn ECL). The percentage of participants with serotype-specific IgG ≥0.35 µg/mL was summarized for each serotype.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3</measure>
    <time_frame>1 month post Vaccination 3 (Month 5)</time_frame>
    <description>Serotype-specific pneumococcal IgG antibody will be assayed using the Meso-Scale Discovery (MSD) Pn electrochemiluminescence assay. The geometric mean concentration (GMC) of serotype-specific IgG will be assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Experience at Least 1 Adverse Event</measure>
    <time_frame>Up to 1 month post Vaccination 4 (up to 14 months)</time_frame>
    <description>An adverse event (AE) is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants with one or more AEs was assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Discontinued From the Study Due to an Adverse Event</measure>
    <time_frame>Up to 1 month post Vaccination 4 (up to 14 months)</time_frame>
    <description>The percentage of participants who discontinued the study because of an AE (as defined above) was assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With a Solicited Injection-site Adverse Event</measure>
    <time_frame>Up to 14 days post any vaccination</time_frame>
    <description>Injection-site AEs solicited on the Vaccine Report Card were redness, swelling, hard lump, and pain/tenderness. The percentage of participants with 1 or more solicited injection-site AEs was assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With a Solicited Systemic Adverse Event</measure>
    <time_frame>Up to 14 days post any vaccination</time_frame>
    <description>Systemic AEs solicited on the Vaccine Report Card were fever, irritability, drowsiness, hive/welts, and appetite loss. The percentage of participants with 1 or more solicited systemic AEs was assessed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4</measure>
    <time_frame>Before Vaccination 4 (Month 10 to 13)</time_frame>
    <description>Serotype-specific pneumococcal IgG antibody was assayed using the MSD Pn electrochemiluminescence assay.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4</measure>
    <time_frame>1 month post vaccination 4 (Month 11-14)</time_frame>
    <description>Serotype-specific pneumococcal IgG antibody was assayed using the MSD Pn electrochemiluminescence assay.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">1051</enrollment>
  <condition>Pneumococcal Infections</condition>
  <arm_group>
    <arm_group_label>V114 Lot 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Infants will receive a 0.5 mL intramuscular injection of V114 Lot 1 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>V114 Lot 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Infants will receive a 0.5 mL intramuscular injection of V114 Lot 2 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prevnar 13™</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Infants will receive a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>V114 Lot 1</intervention_name>
    <description>Lot 1: Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose</description>
    <arm_group_label>V114 Lot 1</arm_group_label>
    <other_name>V114-1</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>V114 Lot 2</intervention_name>
    <description>Lot 2: Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose</description>
    <arm_group_label>V114 Lot 2</arm_group_label>
    <other_name>V114-2</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Prevnar 13™</intervention_name>
    <description>Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) in each 0.5 ml dose</description>
    <arm_group_label>Prevnar 13™</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infant approximately 2 months of age (42 days to 90 days), inclusive&#xD;
&#xD;
          -  In good health&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior administration of any pneumococcal vaccine&#xD;
&#xD;
          -  Known hypersensitivity to any component of the pneumococcal conjugate vaccine or any&#xD;
             diphtheria toxoid-containing vaccine&#xD;
&#xD;
          -  Known or suspected impairment of immunological function&#xD;
&#xD;
          -  History of congenital or acquired immunodeficiency (eg, splenomegaly)&#xD;
&#xD;
          -  Mother has documented human immunodeficiency virus (HIV) infection&#xD;
&#xD;
          -  Mother has documented hepatitis B surface antigen-positive test result&#xD;
&#xD;
          -  Known or history of functional or anatomic asplenia&#xD;
&#xD;
          -  History of failure to thrive&#xD;
&#xD;
          -  History of a coagulation disorder&#xD;
&#xD;
          -  History of autoimmune disease&#xD;
&#xD;
          -  Known neurologic or cognitive behavioral disorder&#xD;
&#xD;
          -  Expects to require systemic corticosteroids within 30 days after each vaccination&#xD;
             during the trial&#xD;
&#xD;
          -  Prior administration of a blood transfusion or blood products, including&#xD;
             immunoglobulin&#xD;
&#xD;
          -  Participated in another clinical trial of an investigational product&#xD;
&#xD;
          -  History of invasive pneumococcal disease or known history of other culture-positive&#xD;
             pneumococcal disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Weeks</minimum_age>
    <maximum_age>12 Weeks</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Merck Sharp &amp; Dohme LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Birmingham Pediatric Research ( Site 0043)</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southeastern Pediatric Associates, P.A. ( Site 0079)</name>
      <address>
        <city>Dothan</city>
        <state>Alabama</state>
        <zip>36305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Clinic of Jonesboro, PA ( Site 0054)</name>
      <address>
        <city>Jonesboro</city>
        <state>Arkansas</state>
        <zip>72401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Premier Health Research Center, LLC ( Site 0035)</name>
      <address>
        <city>Downey</city>
        <state>California</state>
        <zip>90241</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sherif Khamis MD, Inc. ( Site 0044)</name>
      <address>
        <city>Palmdale</city>
        <state>California</state>
        <zip>93550</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente - Roseville ( Site 0045)</name>
      <address>
        <city>Roseville</city>
        <state>California</state>
        <zip>95661</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Clinical Trial - Sacramento ( Site 0076)</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95815</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kentucky Pediatric/Adult Research Inc ( Site 0037)</name>
      <address>
        <city>Bardstown</city>
        <state>Kentucky</state>
        <zip>40004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Louisville: Pediatric Clinical Trials Unit ( Site 0049)</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ACC Pediatric Research ( Site 0039)</name>
      <address>
        <city>Haughton</city>
        <state>Louisiana</state>
        <zip>71037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Woburn Pediatric Associates ( Site 0046)</name>
      <address>
        <city>Woburn</city>
        <state>Massachusetts</state>
        <zip>01801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dundee Clinic ( Site 0063)</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Child Health Care Associates ( Site 0064)</name>
      <address>
        <city>East Syracuse</city>
        <state>New York</state>
        <zip>13057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State University of New York Upstate Medical University ( Site 0065)</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric Associates of Mt. Carmel, Inc. ( Site 0052)</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45245</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Senders Pediatrics ( Site 0058)</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio Pediatric Research Association ( Site 0060)</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45414</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric Medical Associates ( Site 0059)</name>
      <address>
        <city>East Norriton</city>
        <state>Pennsylvania</state>
        <zip>19401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kid's Way Pediatrics ( Site 0036)</name>
      <address>
        <city>Hermitage</city>
        <state>Pennsylvania</state>
        <zip>16148</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thomas Jefferson University ( Site 0067)</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coastal Pediatric Research ( Site 0070)</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29414</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Holston Medical Group [Kingsport, TN] ( Site 0048)</name>
      <address>
        <city>Kingsport</city>
        <state>Tennessee</state>
        <zip>37660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Medical Branch at Galveston ( Site 0056)</name>
      <address>
        <city>Galveston</city>
        <state>Texas</state>
        <zip>77555</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Medical Branch at Galveston ( Site 0068)</name>
      <address>
        <city>League City</city>
        <state>Texas</state>
        <zip>77573</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wee Care Pediatrics ( Site 0042)</name>
      <address>
        <city>Layton</city>
        <state>Utah</state>
        <zip>84041</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cottonwood Pediatrics ( Site 0041)</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Copperview Medical Center ( Site 0062)</name>
      <address>
        <city>South Jordan</city>
        <state>Utah</state>
        <zip>84095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric Research of Charlottesville, LLC ( Site 0066)</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huguenot Pediatrics ( Site 0057)</name>
      <address>
        <city>Midlothian</city>
        <state>Virginia</state>
        <zip>23113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Family Health Care of Ellensburg ( Site 0077)</name>
      <address>
        <city>Ellensburg</city>
        <state>Washington</state>
        <zip>98926</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Ste-Justine ( Site 0084)</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H9H 4M7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McGill University Health Centre - Vaccine Study Centre ( Site 0030)</name>
      <address>
        <city>Pierrefonds</city>
        <state>Quebec</state>
        <zip>H9H 4M7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Quebec Universite de Laval ( Site 0031)</name>
      <address>
        <city>Quebec</city>
        <zip>H9H 4M7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aarhus Universitetshospital-Skejby-Forskningsklinikken for Kvindesygdomme ( Site 0025)</name>
      <address>
        <city>Aarhus N</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OUH Klinisk Forsk center Gyn Obs D. ( Site 0024)</name>
      <address>
        <city>Odense</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tampereen yliopisto Espoon rokotetutkimusklinikka ( Site 0007)</name>
      <address>
        <city>Espoo</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tampereen yliopisto Etela-Helsingin rokotetutkimusklinikka ( Site 0005)</name>
      <address>
        <city>Helsinki</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tampereen yliopisto Ita-Helsingin rokotetutkimusklinikka ( Site 0006)</name>
      <address>
        <city>Helsinki</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tampereen yliopisto Järvenpään rokotetutkimusklinikka ( Site 0003)</name>
      <address>
        <city>Järvenpää</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0004)</name>
      <address>
        <city>Oulu</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tampereen yliopisto Porin rokotetutkimusklinikka ( Site 0008)</name>
      <address>
        <city>Pori</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 0001)</name>
      <address>
        <city>Tampere</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tampereen yliopisto Turun rokotetutkimusklinikka ( Site 0002)</name>
      <address>
        <city>Turku</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Soroka University Medical Center ( Site 0019)</name>
      <address>
        <city>Beer-Sheva</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Soroka University Medical Center - Rahat Family health center ( Site 0020)</name>
      <address>
        <city>Beer-Sheva</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Soroka University Medical Center - Ramot Family health center ( Site 0021)</name>
      <address>
        <city>Beer-Sheva</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Soroka University Medical Center - Vav Family health center ( Site 0022)</name>
      <address>
        <city>Beer-Sheva</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario de Santiago ( Site 0016)</name>
      <address>
        <city>Santiago de Compostela</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unidad de Estudios e Investigacion IHP ( Site 0017)</name>
      <address>
        <city>Sevilla</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Denmark</country>
    <country>Finland</country>
    <country>Israel</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <results_first_submitted>October 2, 2019</results_first_submitted>
  <results_first_submitted_qc>October 2, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">October 23, 2019</results_first_posted>
  <last_update_submitted>October 2, 2019</last_update_submitted>
  <last_update_submitted_qc>October 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumococcal Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heptavalent Pneumococcal Conjugate Vaccine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf</ipd_description>
    <ipd_url>http://engagezone.msd.com/ds_documentation.php</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 15, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/72/NCT02987972/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>V114 Lot 1</title>
          <description>Infants received a 0.5 mL intramuscular injection of V114 Lot 1 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)</description>
        </group>
        <group group_id="P2">
          <title>V114 Lot 2</title>
          <description>Infants received a 0.5 mL intramuscular injection of V114 Lot 2 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)</description>
        </group>
        <group group_id="P3">
          <title>Prevnar 13™</title>
          <description>Infants received a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="351"/>
                <participants group_id="P2" count="350"/>
                <participants group_id="P3" count="350"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Vaccination 1</title>
              <participants_list>
                <participants group_id="P1" count="350"/>
                <participants group_id="P2" count="347"/>
                <participants group_id="P3" count="347"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Vaccination 2</title>
              <participants_list>
                <participants group_id="P1" count="333"/>
                <participants group_id="P2" count="335"/>
                <participants group_id="P3" count="335"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Vaccination 3</title>
              <participants_list>
                <participants group_id="P1" count="330"/>
                <participants group_id="P2" count="331"/>
                <participants group_id="P3" count="332"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Vaccination 4</title>
              <participants_list>
                <participants group_id="P1" count="310"/>
                <participants group_id="P2" count="306"/>
                <participants group_id="P3" count="311"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="308"/>
                <participants group_id="P2" count="305"/>
                <participants group_id="P3" count="308"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
                <participants group_id="P2" count="45"/>
                <participants group_id="P3" count="42"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="12"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="17"/>
                <participants group_id="P3" count="21"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>V114 Lot 1</title>
          <description>Infants received a 0.5 mL intramuscular injection of V114 Lot 1 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)</description>
        </group>
        <group group_id="B2">
          <title>V114 Lot 2</title>
          <description>Infants received a 0.5 mL intramuscular injection of V114 Lot 2 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)</description>
        </group>
        <group group_id="B3">
          <title>Prevnar 13™</title>
          <description>Infants received a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)</description>
        </group>
        <group group_id="B4">
          <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="351"/>
            <count group_id="B2" value="350"/>
            <count group_id="B3" value="350"/>
            <count group_id="B4" value="1051"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Infants and toddlers (28 days-23 months)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="351"/>
                    <measurement group_id="B2" value="350"/>
                    <measurement group_id="B3" value="350"/>
                    <measurement group_id="B4" value="1051"/>
                  </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="164"/>
                    <measurement group_id="B2" value="186"/>
                    <measurement group_id="B3" value="173"/>
                    <measurement group_id="B4" value="523"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="187"/>
                    <measurement group_id="B2" value="164"/>
                    <measurement group_id="B3" value="177"/>
                    <measurement group_id="B4" value="528"/>
                  </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="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="33"/>
                    <measurement group_id="B4" value="91"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="290"/>
                    <measurement group_id="B2" value="296"/>
                    <measurement group_id="B3" value="289"/>
                    <measurement group_id="B4" value="875"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="22"/>
                    <measurement group_id="B4" value="65"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity</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="49"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="53"/>
                    <measurement group_id="B4" value="138"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic Or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="300"/>
                    <measurement group_id="B2" value="313"/>
                    <measurement group_id="B3" value="294"/>
                    <measurement group_id="B4" value="907"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</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="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3</title>
        <description>Serotype-specific pneumococcal IgG antibody was measured using the Meso-Scale Discovery (MSD) Pneumococcal electrochemiluminescence assay (Pn ECL). The percentage of participants with serotype-specific IgG ≥0.35 µg/mL was summarized for each serotype.</description>
        <time_frame>1 month post vaccination 3 (Month 5)</time_frame>
        <population>Participants not considered as protocol violators and had data available for endpoint. Violations could include but were not limited to: failure to receive the scheduled correct doses within scheduled timeframe and lack of valid serology results available from 28 to 42 days following the dose being analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>V114 Lot 1</title>
            <description>Infants received a 0.5 mL intramuscular injection of V114 Lot 1 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)</description>
          </group>
          <group group_id="O2">
            <title>V114 Lot 2</title>
            <description>Infants received a 0.5 mL intramuscular injection of V114 Lot 2 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)</description>
          </group>
          <group group_id="O3">
            <title>Prevnar 13™</title>
            <description>Infants received a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3</title>
          <description>Serotype-specific pneumococcal IgG antibody was measured using the Meso-Scale Discovery (MSD) Pneumococcal electrochemiluminescence assay (Pn ECL). The percentage of participants with serotype-specific IgG ≥0.35 µg/mL was summarized for each serotype.</description>
          <population>Participants not considered as protocol violators and had data available for endpoint. Violations could include but were not limited to: failure to receive the scheduled correct doses within scheduled timeframe and lack of valid serology results available from 28 to 42 days following the dose being analyzed.</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="329"/>
                <count group_id="O2" value="330"/>
                <count group_id="O3" value="332"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Type 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="278"/>
                    <count group_id="O2" value="273"/>
                    <count group_id="O3" value="291"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.8" lower_limit="93.94" upper_limit="98.51"/>
                    <measurement group_id="O2" value="97.8" lower_limit="95.28" upper_limit="99.19"/>
                    <measurement group_id="O3" value="96.9" lower_limit="94.21" upper_limit="98.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="277"/>
                    <count group_id="O2" value="273"/>
                    <count group_id="O3" value="291"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.0" lower_limit="93.01" upper_limit="98.00"/>
                    <measurement group_id="O2" value="94.1" lower_limit="90.66" upper_limit="96.61"/>
                    <measurement group_id="O3" value="71.8" lower_limit="66.28" upper_limit="76.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="273"/>
                    <count group_id="O2" value="272"/>
                    <count group_id="O3" value="288"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.2" lower_limit="95.78" upper_limit="99.40"/>
                    <measurement group_id="O2" value="97.1" lower_limit="94.29" upper_limit="98.72"/>
                    <measurement group_id="O3" value="95.1" lower_limit="91.98" upper_limit="97.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="278"/>
                    <count group_id="O2" value="272"/>
                    <count group_id="O3" value="290"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.0" lower_limit="93.03" upper_limit="98.01"/>
                    <measurement group_id="O2" value="96.0" lower_limit="92.88" upper_limit="97.96"/>
                    <measurement group_id="O3" value="96.6" lower_limit="93.75" upper_limit="98.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 6A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="278"/>
                    <count group_id="O2" value="273"/>
                    <count group_id="O3" value="290"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.6" lower_limit="86.60" upper_limit="93.80"/>
                    <measurement group_id="O2" value="95.6" lower_limit="92.45" upper_limit="97.71"/>
                    <measurement group_id="O3" value="96.2" lower_limit="93.31" upper_limit="98.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 6B</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="276"/>
                    <count group_id="O2" value="273"/>
                    <count group_id="O3" value="290"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.6" lower_limit="86.50" upper_limit="93.75"/>
                    <measurement group_id="O2" value="92.3" lower_limit="88.48" upper_limit="95.18"/>
                    <measurement group_id="O3" value="91.4" lower_limit="87.54" upper_limit="94.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 7F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="278"/>
                    <count group_id="O2" value="273"/>
                    <count group_id="O3" value="290"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.6" lower_limit="98.01" upper_limit="99.99"/>
                    <measurement group_id="O2" value="99.3" lower_limit="97.38" upper_limit="99.91"/>
                    <measurement group_id="O3" value="99.0" lower_limit="97.01" upper_limit="99.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 9V</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="278"/>
                    <count group_id="O2" value="273"/>
                    <count group_id="O3" value="289"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.1" lower_limit="94.41" upper_limit="98.75"/>
                    <measurement group_id="O2" value="97.8" lower_limit="95.28" upper_limit="99.19"/>
                    <measurement group_id="O3" value="95.8" lower_limit="92.86" upper_limit="97.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="277"/>
                    <count group_id="O2" value="273"/>
                    <count group_id="O3" value="289"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.3" lower_limit="97.42" upper_limit="99.91"/>
                    <measurement group_id="O2" value="97.4" lower_limit="94.79" upper_limit="98.96"/>
                    <measurement group_id="O3" value="97.2" lower_limit="94.62" upper_limit="98.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 18C</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="278"/>
                    <count group_id="O2" value="273"/>
                    <count group_id="O3" value="291"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.8" lower_limit="93.94" upper_limit="98.51"/>
                    <measurement group_id="O2" value="98.2" lower_limit="95.78" upper_limit="99.40"/>
                    <measurement group_id="O3" value="95.5" lower_limit="92.48" upper_limit="97.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 19A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="278"/>
                    <count group_id="O2" value="273"/>
                    <count group_id="O3" value="290"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.9" lower_limit="96.88" upper_limit="99.78"/>
                    <measurement group_id="O2" value="98.5" lower_limit="96.29" upper_limit="99.60"/>
                    <measurement group_id="O3" value="98.6" lower_limit="96.51" upper_limit="99.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 19F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="278"/>
                    <count group_id="O2" value="273"/>
                    <count group_id="O3" value="290"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="98.68" upper_limit="100.00"/>
                    <measurement group_id="O2" value="98.9" lower_limit="96.82" upper_limit="99.77"/>
                    <measurement group_id="O3" value="99.7" lower_limit="98.09" upper_limit="99.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 23F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="278"/>
                    <count group_id="O2" value="273"/>
                    <count group_id="O3" value="290"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.4" lower_limit="88.68" upper_limit="95.26"/>
                    <measurement group_id="O2" value="94.9" lower_limit="91.55" upper_limit="97.17"/>
                    <measurement group_id="O3" value="90.7" lower_limit="86.74" upper_limit="93.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 1</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.</non_inferiority_desc>
            <p_value>&lt; 0.001</p_value>
            <method>Miettinen and Nurminen</method>
            <param_type>Difference in Percentages</param_type>
            <param_value>-0.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.3</ci_lower_limit>
            <ci_upper_limit>3.0</ci_upper_limit>
            <estimate_desc>Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 3</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.</non_inferiority_desc>
            <p_value>&lt; 0.001</p_value>
            <method>Miettinen and Nurminen</method>
            <param_type>Difference in Percentages</param_type>
            <param_value>24.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>18.7</ci_lower_limit>
            <ci_upper_limit>30.0</ci_upper_limit>
            <estimate_desc>Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 4</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.</non_inferiority_desc>
            <p_value>&lt; 0.001</p_value>
            <method>Miettinen and Nurminen</method>
            <param_type>Difference in Percentages</param_type>
            <param_value>3.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0</ci_lower_limit>
            <ci_upper_limit>6.4</ci_upper_limit>
            <estimate_desc>Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 5</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.</non_inferiority_desc>
            <p_value>&lt; 0.001</p_value>
            <method>Miettinen and Nurminen</method>
            <param_type>Difference in Percentages</param_type>
            <param_value>-0.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.9</ci_lower_limit>
            <ci_upper_limit>2.8</ci_upper_limit>
            <estimate_desc>Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 6A</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.</non_inferiority_desc>
            <p_value>&lt; 0.001</p_value>
            <method>Miettinen and Nurminen</method>
            <param_type>Difference in Percentages</param_type>
            <param_value>-5.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.0</ci_lower_limit>
            <ci_upper_limit>-1.6</ci_upper_limit>
            <estimate_desc>Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 6B</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.</non_inferiority_desc>
            <p_value>&lt; 0.001</p_value>
            <method>Miettinen and Nurminen</method>
            <param_type>Difference in Percentages</param_type>
            <param_value>-0.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.7</ci_lower_limit>
            <ci_upper_limit>4.0</ci_upper_limit>
            <estimate_desc>Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 7F</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.</non_inferiority_desc>
            <p_value>&lt; 0.001</p_value>
            <method>Miettinen and Nurminen</method>
            <param_type>Difference in Percentages</param_type>
            <param_value>0.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.1</ci_lower_limit>
            <ci_upper_limit>2.7</ci_upper_limit>
            <estimate_desc>Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 9V</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.</non_inferiority_desc>
            <p_value>&lt; 0.001</p_value>
            <method>Miettinen and Nurminen</method>
            <param_type>Difference in Percentages</param_type>
            <param_value>1.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.9</ci_lower_limit>
            <ci_upper_limit>4.6</ci_upper_limit>
            <estimate_desc>Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 14</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.</non_inferiority_desc>
            <p_value>&lt; 0.001</p_value>
            <method>Miettinen and Nurminen</method>
            <param_type>Difference in Percentages</param_type>
            <param_value>2.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.2</ci_lower_limit>
            <ci_upper_limit>4.7</ci_upper_limit>
            <estimate_desc>Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 18C</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.</non_inferiority_desc>
            <p_value>&lt; 0.001</p_value>
            <method>Miettinen and Nurminen</method>
            <param_type>Difference in Percentages</param_type>
            <param_value>1.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.1</ci_lower_limit>
            <ci_upper_limit>4.7</ci_upper_limit>
            <estimate_desc>Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 19A</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.</non_inferiority_desc>
            <p_value>&lt; 0.001</p_value>
            <method>Miettinen and Nurminen</method>
            <param_type>Difference in Percentages</param_type>
            <param_value>0.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.9</ci_lower_limit>
            <ci_upper_limit>2.6</ci_upper_limit>
            <estimate_desc>Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 19F</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.</non_inferiority_desc>
            <p_value>&lt; 0.001</p_value>
            <method>Miettinen and Nurminen</method>
            <param_type>Difference in Percentages</param_type>
            <param_value>0.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.0</ci_lower_limit>
            <ci_upper_limit>1.9</ci_upper_limit>
            <estimate_desc>Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 23F</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.</non_inferiority_desc>
            <p_value>&lt; 0.001</p_value>
            <method>Miettinen and Nurminen</method>
            <param_type>Difference in Percentages</param_type>
            <param_value>1.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.9</ci_lower_limit>
            <ci_upper_limit>6.5</ci_upper_limit>
            <estimate_desc>Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 1</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.</non_inferiority_desc>
            <p_value>&lt; 0.001</p_value>
            <method>Miettinen and Nurminen</method>
            <param_type>Difference in Percentages</param_type>
            <param_value>0.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.0</ci_lower_limit>
            <ci_upper_limit>3.9</ci_upper_limit>
            <estimate_desc>Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 3</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.</non_inferiority_desc>
            <p_value>&lt; 0.001</p_value>
            <method>Miettinen and Nurminen</method>
            <param_type>Difference in Percentages</param_type>
            <param_value>22.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>16.5</ci_lower_limit>
            <ci_upper_limit>28.3</ci_upper_limit>
            <estimate_desc>Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 4</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.</non_inferiority_desc>
            <p_value>&lt; 0.001</p_value>
            <method>Miettinen and Nurminen</method>
            <param_type>Difference in Percentages</param_type>
            <param_value>1.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.4</ci_lower_limit>
            <ci_upper_limit>5.4</ci_upper_limit>
            <estimate_desc>Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 5</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.</non_inferiority_desc>
            <p_value>&lt; 0.001</p_value>
            <method>Miettinen and Nurminen</method>
            <param_type>Difference in Percentages</param_type>
            <param_value>-0.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.1</ci_lower_limit>
            <ci_upper_limit>2.7</ci_upper_limit>
            <estimate_desc>Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 6A</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.</non_inferiority_desc>
            <p_value>&lt; 0.001</p_value>
            <method>Miettinen and Nurminen</method>
            <param_type>Difference in Percentages</param_type>
            <param_value>-0.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.2</ci_lower_limit>
            <ci_upper_limit>2.8</ci_upper_limit>
            <estimate_desc>Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 6B</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.</non_inferiority_desc>
            <p_value>&lt; 0.001</p_value>
            <method>Miettinen and Nurminen</method>
            <param_type>Difference in Percentages</param_type>
            <param_value>0.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.7</ci_lower_limit>
            <ci_upper_limit>5.6</ci_upper_limit>
            <estimate_desc>Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 7F</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.</non_inferiority_desc>
            <p_value>&lt; 0.001</p_value>
            <method>Miettinen and Nurminen</method>
            <param_type>Difference in Percentages</param_type>
            <param_value>0.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.7</ci_lower_limit>
            <ci_upper_limit>2.4</ci_upper_limit>
            <estimate_desc>Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 9V</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.</non_inferiority_desc>
            <p_value>&lt; 0.001</p_value>
            <method>Miettinen and Nurminen</method>
            <param_type>Difference in Percentages</param_type>
            <param_value>2.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.1</ci_lower_limit>
            <ci_upper_limit>5.2</ci_upper_limit>
            <estimate_desc>Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 14</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.</non_inferiority_desc>
            <p_value>&lt; 0.001</p_value>
            <method>Miettinen and Nurminen</method>
            <param_type>Difference in Percentages</param_type>
            <param_value>0.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.8</ci_lower_limit>
            <ci_upper_limit>3.1</ci_upper_limit>
            <estimate_desc>Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 18C</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.</non_inferiority_desc>
            <p_value>&lt; 0.001</p_value>
            <method>Miettinen and Nurminen</method>
            <param_type>Difference in Percentages</param_type>
            <param_value>2.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.3</ci_lower_limit>
            <ci_upper_limit>5.9</ci_upper_limit>
            <estimate_desc>Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 19A</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.</non_inferiority_desc>
            <p_value>&lt; 0.001</p_value>
            <method>Miettinen and Nurminen</method>
            <param_type>Difference in Percentages</param_type>
            <param_value>-0.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.5</ci_lower_limit>
            <ci_upper_limit>2.2</ci_upper_limit>
            <estimate_desc>Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 19F</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.</non_inferiority_desc>
            <p_value>&lt; 0.001</p_value>
            <method>Miettinen and Nurminen</method>
            <param_type>Difference in Percentages</param_type>
            <param_value>-0.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.9</ci_lower_limit>
            <ci_upper_limit>0.9</ci_upper_limit>
            <estimate_desc>Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 23F</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.</non_inferiority_desc>
            <p_value>&lt; 0.001</p_value>
            <method>Miettinen and Nurminen</method>
            <param_type>Difference in Percentages</param_type>
            <param_value>4.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.1</ci_lower_limit>
            <ci_upper_limit>8.7</ci_upper_limit>
            <estimate_desc>Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3</title>
        <description>Serotype-specific pneumococcal IgG antibody will be assayed using the Meso-Scale Discovery (MSD) Pn electrochemiluminescence assay. The geometric mean concentration (GMC) of serotype-specific IgG will be assessed.</description>
        <time_frame>1 month post Vaccination 3 (Month 5)</time_frame>
        <population>Participants not considered as protocol violators and had data available for endpoint. Violations could include but were not limited to: failure to receive the scheduled correct doses within scheduled timeframe and lack of valid serology results available from 28 to 42 days following the dose being analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>V114 Lot 1</title>
            <description>Infants received a 0.5 mL intramuscular injection of V114 Lot 1 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)</description>
          </group>
          <group group_id="O2">
            <title>V114 Lot 2</title>
            <description>Infants received a 0.5 mL intramuscular injection of V114 Lot 2 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)</description>
          </group>
          <group group_id="O3">
            <title>Prevnar 13™</title>
            <description>Infants received a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3</title>
          <description>Serotype-specific pneumococcal IgG antibody will be assayed using the Meso-Scale Discovery (MSD) Pn electrochemiluminescence assay. The geometric mean concentration (GMC) of serotype-specific IgG will be assessed.</description>
          <population>Participants not considered as protocol violators and had data available for endpoint. Violations could include but were not limited to: failure to receive the scheduled correct doses within scheduled timeframe and lack of valid serology results available from 28 to 42 days following the dose being analyzed.</population>
          <units>µg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="329"/>
                <count group_id="O2" value="330"/>
                <count group_id="O3" value="332"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Type 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="278"/>
                    <count group_id="O2" value="273"/>
                    <count group_id="O3" value="291"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.19" lower_limit="1.10" upper_limit="1.27"/>
                    <measurement group_id="O2" value="1.37" lower_limit="1.26" upper_limit="1.49"/>
                    <measurement group_id="O3" value="1.65" lower_limit="1.50" upper_limit="1.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="277"/>
                    <count group_id="O2" value="273"/>
                    <count group_id="O3" value="291"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.04" lower_limit="0.97" upper_limit="1.12"/>
                    <measurement group_id="O2" value="1.02" lower_limit="0.93" upper_limit="1.11"/>
                    <measurement group_id="O3" value="0.53" lower_limit="0.48" upper_limit="0.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="273"/>
                    <count group_id="O2" value="272"/>
                    <count group_id="O3" value="288"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.30" lower_limit="1.21" upper_limit="1.40"/>
                    <measurement group_id="O2" value="1.27" lower_limit="1.17" upper_limit="1.37"/>
                    <measurement group_id="O3" value="1.26" lower_limit="1.14" upper_limit="1.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="278"/>
                    <count group_id="O2" value="272"/>
                    <count group_id="O3" value="290"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.37" lower_limit="1.25" upper_limit="1.50"/>
                    <measurement group_id="O2" value="1.45" lower_limit="1.32" upper_limit="1.59"/>
                    <measurement group_id="O3" value="1.75" lower_limit="1.58" upper_limit="1.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 6A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="278"/>
                    <count group_id="O2" value="273"/>
                    <count group_id="O3" value="290"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.42" lower_limit="1.27" upper_limit="1.59"/>
                    <measurement group_id="O2" value="1.48" lower_limit="1.34" upper_limit="1.63"/>
                    <measurement group_id="O3" value="2.62" lower_limit="2.35" upper_limit="2.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 6B</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="276"/>
                    <count group_id="O2" value="273"/>
                    <count group_id="O3" value="290"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.95" lower_limit="1.68" upper_limit="2.28"/>
                    <measurement group_id="O2" value="1.71" lower_limit="1.49" upper_limit="1.96"/>
                    <measurement group_id="O3" value="1.89" lower_limit="1.64" upper_limit="2.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 7F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="278"/>
                    <count group_id="O2" value="273"/>
                    <count group_id="O3" value="290"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.43" lower_limit="2.26" upper_limit="2.62"/>
                    <measurement group_id="O2" value="2.42" lower_limit="2.23" upper_limit="2.62"/>
                    <measurement group_id="O3" value="2.98" lower_limit="2.72" upper_limit="3.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 9V</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="278"/>
                    <count group_id="O2" value="273"/>
                    <count group_id="O3" value="289"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.40" lower_limit="1.28" upper_limit="1.52"/>
                    <measurement group_id="O2" value="1.70" lower_limit="1.56" upper_limit="1.86"/>
                    <measurement group_id="O3" value="1.59" lower_limit="1.44" upper_limit="1.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="277"/>
                    <count group_id="O2" value="273"/>
                    <count group_id="O3" value="289"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.08" lower_limit="4.63" upper_limit="5.58"/>
                    <measurement group_id="O2" value="4.78" lower_limit="4.27" upper_limit="5.34"/>
                    <measurement group_id="O3" value="5.79" lower_limit="5.11" upper_limit="6.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 18C</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="278"/>
                    <count group_id="O2" value="273"/>
                    <count group_id="O3" value="291"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.24" lower_limit="1.15" upper_limit="1.35"/>
                    <measurement group_id="O2" value="1.65" lower_limit="1.52" upper_limit="1.79"/>
                    <measurement group_id="O3" value="1.67" lower_limit="1.52" upper_limit="1.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 19A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="278"/>
                    <count group_id="O2" value="273"/>
                    <count group_id="O3" value="290"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.63" lower_limit="1.52" upper_limit="1.76"/>
                    <measurement group_id="O2" value="1.64" lower_limit="1.51" upper_limit="1.78"/>
                    <measurement group_id="O3" value="1.99" lower_limit="1.83" upper_limit="2.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 19F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="278"/>
                    <count group_id="O2" value="273"/>
                    <count group_id="O3" value="290"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.26" lower_limit="2.10" upper_limit="2.43"/>
                    <measurement group_id="O2" value="2.33" lower_limit="2.15" upper_limit="2.53"/>
                    <measurement group_id="O3" value="2.57" lower_limit="2.38" upper_limit="2.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 23F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="278"/>
                    <count group_id="O2" value="273"/>
                    <count group_id="O3" value="290"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.22" lower_limit="1.10" upper_limit="1.35"/>
                    <measurement group_id="O2" value="1.47" lower_limit="1.32" upper_limit="1.63"/>
                    <measurement group_id="O3" value="1.25" lower_limit="1.11" upper_limit="1.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 22F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="278"/>
                    <count group_id="O2" value="273"/>
                    <count group_id="O3" value="291"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.80" lower_limit="4.40" upper_limit="5.24"/>
                    <measurement group_id="O2" value="4.18" lower_limit="3.76" upper_limit="4.63"/>
                    <measurement group_id="O3" value="0.05" lower_limit="0.05" upper_limit="0.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 33F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="278"/>
                    <count group_id="O2" value="273"/>
                    <count group_id="O3" value="289"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.58" lower_limit="1.34" upper_limit="1.86"/>
                    <measurement group_id="O2" value="1.51" lower_limit="1.30" upper_limit="1.75"/>
                    <measurement group_id="O3" value="0.05" lower_limit="0.04" upper_limit="0.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 1</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>0.72</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.64</ci_lower_limit>
            <ci_upper_limit>0.81</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on analysis of variance (ANOVA) model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 3</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>1.98</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.75</ci_lower_limit>
            <ci_upper_limit>2.23</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 4</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC 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>0.92</ci_lower_limit>
            <ci_upper_limit>1.16</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 5</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>0.78</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.68</ci_lower_limit>
            <ci_upper_limit>0.89</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 6A</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>0.54</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.47</ci_lower_limit>
            <ci_upper_limit>0.63</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 6B</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC 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>0.84</ci_lower_limit>
            <ci_upper_limit>1.26</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 7F</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>0.82</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.73</ci_lower_limit>
            <ci_upper_limit>0.92</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 9V</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC 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>0.77</ci_lower_limit>
            <ci_upper_limit>1.00</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 14</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC 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>0.75</ci_lower_limit>
            <ci_upper_limit>1.03</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 18C</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>0.75</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.66</ci_lower_limit>
            <ci_upper_limit>0.84</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 19A</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>0.82</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.73</ci_lower_limit>
            <ci_upper_limit>0.92</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 19F</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC 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>0.79</ci_lower_limit>
            <ci_upper_limit>0.98</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on analysis of variance (ANOVA) model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 23F</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC 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>0.84</ci_lower_limit>
            <ci_upper_limit>1.13</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 22F</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>92.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>80.84</ci_lower_limit>
            <ci_upper_limit>104.81</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 33F</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>34.41</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>28.50</ci_lower_limit>
            <ci_upper_limit>41.54</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 1</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC 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>0.74</ci_lower_limit>
            <ci_upper_limit>0.94</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 3</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>1.93</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.71</ci_lower_limit>
            <ci_upper_limit>2.18</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 4</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC 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>0.90</ci_lower_limit>
            <ci_upper_limit>1.14</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 5</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC 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>0.72</ci_lower_limit>
            <ci_upper_limit>0.94</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 6A</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>0.57</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.49</ci_lower_limit>
            <ci_upper_limit>0.66</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 6B</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>0.90</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.74</ci_lower_limit>
            <ci_upper_limit>1.10</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 7F</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>0.81</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>0.91</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 9V</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC 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>0.94</ci_lower_limit>
            <ci_upper_limit>1.22</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 14</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC 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>0.71</ci_lower_limit>
            <ci_upper_limit>0.97</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 18C</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC 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>0.88</ci_lower_limit>
            <ci_upper_limit>1.12</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 19A</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>0.82</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.73</ci_lower_limit>
            <ci_upper_limit>0.92</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 19F</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC 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>0.81</ci_lower_limit>
            <ci_upper_limit>1.01</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 23F</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>1.18</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>1.37</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 22F</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>80.09</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>70.30</ci_lower_limit>
            <ci_upper_limit>91.24</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 33F</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>32.92</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>27.25</ci_lower_limit>
            <ci_upper_limit>39.78</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Experience at Least 1 Adverse Event</title>
        <description>An adverse event (AE) is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants with one or more AEs was assessed.</description>
        <time_frame>Up to 1 month post Vaccination 4 (up to 14 months)</time_frame>
        <population>All participants that received at least 1 vaccination and had data available for endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>V114 Lot 1</title>
            <description>Infants received a 0.5 mL intramuscular injection of V114 Lot 1 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)</description>
          </group>
          <group group_id="O2">
            <title>V114 Lot 2</title>
            <description>Infants received a 0.5 mL intramuscular injection of V114 Lot 2 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)</description>
          </group>
          <group group_id="O3">
            <title>Prevnar 13™</title>
            <description>Infants received a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Experience at Least 1 Adverse Event</title>
          <description>An adverse event (AE) is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants with one or more AEs was assessed.</description>
          <population>All participants that received at least 1 vaccination and had data available for endpoint.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="350"/>
                <count group_id="O2" value="347"/>
                <count group_id="O3" value="347"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.7"/>
                    <measurement group_id="O2" value="97.7"/>
                    <measurement group_id="O3" value="95.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Difference in percentages calculated as V114 Lot 1 minus Prevnar 13™. Confidence intervals based on Miettinen and Nurminen method.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Difference in Percentages</param_type>
            <param_value>0.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.1</ci_lower_limit>
            <ci_upper_limit>3.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Difference in percentages calculated as V114 Lot 2 minus Prevnar 13™. Confidence intervals based on Miettinen and Nurminen method.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Difference in Percentages</param_type>
            <param_value>2.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.7</ci_lower_limit>
            <ci_upper_limit>5.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Discontinued From the Study Due to an Adverse Event</title>
        <description>The percentage of participants who discontinued the study because of an AE (as defined above) was assessed.</description>
        <time_frame>Up to 1 month post Vaccination 4 (up to 14 months)</time_frame>
        <population>All participants that received at least 1 vaccination and had data available for endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>V114 Lot 1</title>
            <description>Infants received a 0.5 mL intramuscular injection of V114 Lot 1 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)</description>
          </group>
          <group group_id="O2">
            <title>V114 Lot 2</title>
            <description>Infants received a 0.5 mL intramuscular injection of V114 Lot 2 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)</description>
          </group>
          <group group_id="O3">
            <title>Prevnar 13™</title>
            <description>Infants received a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Discontinued From the Study Due to an Adverse Event</title>
          <description>The percentage of participants who discontinued the study because of an AE (as defined above) was assessed.</description>
          <population>All participants that received at least 1 vaccination and had data available for endpoint.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="350"/>
                <count group_id="O2" value="347"/>
                <count group_id="O3" value="347"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3"/>
                    <measurement group_id="O2" value="0.3"/>
                    <measurement group_id="O3" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Difference in percentages calculated as V114 Lot 1 minus Prevnar 13™. Confidence intervals based on Miettinen and Nurminen method.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Difference in Percentages</param_type>
            <param_value>0.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.8</ci_lower_limit>
            <ci_upper_limit>1.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Difference in percentages calculated as V114 Lot 2 minus Prevnar 13™. Confidence intervals based on Miettinen and Nurminen method.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Difference in Percentages</param_type>
            <param_value>0.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.8</ci_lower_limit>
            <ci_upper_limit>1.6</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With a Solicited Injection-site Adverse Event</title>
        <description>Injection-site AEs solicited on the Vaccine Report Card were redness, swelling, hard lump, and pain/tenderness. The percentage of participants with 1 or more solicited injection-site AEs was assessed.</description>
        <time_frame>Up to 14 days post any vaccination</time_frame>
        <population>All participants that received at least 1 vaccination and had data available for endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>V114 Lot 1</title>
            <description>Infants received a 0.5 mL intramuscular injection of V114 Lot 1 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)</description>
          </group>
          <group group_id="O2">
            <title>V114 Lot 2</title>
            <description>Infants received a 0.5 mL intramuscular injection of V114 Lot 2 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)</description>
          </group>
          <group group_id="O3">
            <title>Prevnar 13™</title>
            <description>Infants received a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a Solicited Injection-site Adverse Event</title>
          <description>Injection-site AEs solicited on the Vaccine Report Card were redness, swelling, hard lump, and pain/tenderness. The percentage of participants with 1 or more solicited injection-site AEs was assessed.</description>
          <population>All participants that received at least 1 vaccination and had data available for endpoint.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="350"/>
                <count group_id="O2" value="347"/>
                <count group_id="O3" value="347"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.6"/>
                    <measurement group_id="O2" value="76.7"/>
                    <measurement group_id="O3" value="70.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Difference in Percentages</param_type>
            <param_value>6.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.3</ci_lower_limit>
            <ci_upper_limit>12.8</ci_upper_limit>
            <estimate_desc>Difference in percentages calculated as V114 Lot 1 minus Prevnar 13™.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Difference in Percentages</param_type>
            <param_value>6.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.2</ci_lower_limit>
            <ci_upper_limit>12.9</ci_upper_limit>
            <estimate_desc>Difference in percentages calculated as V114 Lot 2 minus Prevnar 13™.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With a Solicited Systemic Adverse Event</title>
        <description>Systemic AEs solicited on the Vaccine Report Card were fever, irritability, drowsiness, hive/welts, and appetite loss. The percentage of participants with 1 or more solicited systemic AEs was assessed.</description>
        <time_frame>Up to 14 days post any vaccination</time_frame>
        <population>All participants that received at least 1 vaccination and had data available for endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>V114 Lot 1</title>
            <description>Infants received a 0.5 mL intramuscular injection of V114 Lot 1 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)</description>
          </group>
          <group group_id="O2">
            <title>V114 Lot 2</title>
            <description>Infants received a 0.5 mL intramuscular injection of V114 Lot 2 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)</description>
          </group>
          <group group_id="O3">
            <title>Prevnar 13™</title>
            <description>Infants received a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a Solicited Systemic Adverse Event</title>
          <description>Systemic AEs solicited on the Vaccine Report Card were fever, irritability, drowsiness, hive/welts, and appetite loss. The percentage of participants with 1 or more solicited systemic AEs was assessed.</description>
          <population>All participants that received at least 1 vaccination and had data available for endpoint.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="350"/>
                <count group_id="O2" value="347"/>
                <count group_id="O3" value="347"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.3"/>
                    <measurement group_id="O2" value="92.2"/>
                    <measurement group_id="O3" value="89.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.772</p_value>
            <method>Miettinen and Nurminen</method>
            <param_type>Difference in Percentages</param_type>
            <param_value>0.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.9</ci_lower_limit>
            <ci_upper_limit>5.2</ci_upper_limit>
            <estimate_desc>Difference in percentages calculated as V114 Lot 1 minus Prevnar 13™.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.235</p_value>
            <method>Miettinen and Nurminen</method>
            <param_type>Difference in Percentages</param_type>
            <param_value>2.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.7</ci_lower_limit>
            <ci_upper_limit>7.0</ci_upper_limit>
            <estimate_desc>Difference in percentages calculated as V114 Lot 2 minus Prevnar 13™.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4</title>
        <description>Serotype-specific pneumococcal IgG antibody was assayed using the MSD Pn electrochemiluminescence assay.</description>
        <time_frame>Before Vaccination 4 (Month 10 to 13)</time_frame>
        <population>Participants not considered as protocol violators and had data available for endpoint. Violations could include but were not limited to: failure to receive the scheduled correct doses within scheduled timeframe and lack of valid serology results available from 28 to 42 days following the dose being analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>V114 Lot 1</title>
            <description>Infants received a 0.5 mL intramuscular injection of V114 Lot 1 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)</description>
          </group>
          <group group_id="O2">
            <title>V114 Lot 2</title>
            <description>Infants received a 0.5 mL intramuscular injection of V114 Lot 2 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)</description>
          </group>
          <group group_id="O3">
            <title>Prevnar 13™</title>
            <description>Infants received a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4</title>
          <description>Serotype-specific pneumococcal IgG antibody was assayed using the MSD Pn electrochemiluminescence assay.</description>
          <population>Participants not considered as protocol violators and had data available for endpoint. Violations could include but were not limited to: failure to receive the scheduled correct doses within scheduled timeframe and lack of valid serology results available from 28 to 42 days following the dose being analyzed.</population>
          <units>µg/mL</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="329"/>
                <count group_id="O2" value="330"/>
                <count group_id="O3" value="332"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Type 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="280"/>
                    <count group_id="O2" value="283"/>
                    <count group_id="O3" value="287"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.32" lower_limit="0.29" upper_limit="0.34"/>
                    <measurement group_id="O2" value="0.35" lower_limit="0.33" upper_limit="0.38"/>
                    <measurement group_id="O3" value="0.46" lower_limit="0.43" upper_limit="0.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="280"/>
                    <count group_id="O2" value="283"/>
                    <count group_id="O3" value="287"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.25" lower_limit="0.23" upper_limit="0.27"/>
                    <measurement group_id="O2" value="0.26" lower_limit="0.24" upper_limit="0.29"/>
                    <measurement group_id="O3" value="0.12" lower_limit="0.11" upper_limit="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="280"/>
                    <count group_id="O2" value="283"/>
                    <count group_id="O3" value="287"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.26" lower_limit="0.24" upper_limit="0.28"/>
                    <measurement group_id="O2" value="0.26" lower_limit="0.24" upper_limit="0.27"/>
                    <measurement group_id="O3" value="0.27" lower_limit="0.25" upper_limit="0.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="280"/>
                    <count group_id="O2" value="283"/>
                    <count group_id="O3" value="287"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.74" lower_limit="0.69" upper_limit="0.80"/>
                    <measurement group_id="O2" value="0.74" lower_limit="0.68" upper_limit="0.79"/>
                    <measurement group_id="O3" value="0.86" lower_limit="0.80" upper_limit="0.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 6A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="280"/>
                    <count group_id="O2" value="283"/>
                    <count group_id="O3" value="287"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.33" lower_limit="0.30" upper_limit="0.37"/>
                    <measurement group_id="O2" value="0.38" lower_limit="0.35" upper_limit="0.41"/>
                    <measurement group_id="O3" value="0.58" lower_limit="0.54" upper_limit="0.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 6B</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="280"/>
                    <count group_id="O2" value="283"/>
                    <count group_id="O3" value="287"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.61" lower_limit="0.55" upper_limit="0.67"/>
                    <measurement group_id="O2" value="0.56" lower_limit="0.51" upper_limit="0.62"/>
                    <measurement group_id="O3" value="0.50" lower_limit="0.46" upper_limit="0.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 7F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="280"/>
                    <count group_id="O2" value="283"/>
                    <count group_id="O3" value="287"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.77" lower_limit="0.72" upper_limit="0.83"/>
                    <measurement group_id="O2" value="0.81" lower_limit="0.76" upper_limit="0.88"/>
                    <measurement group_id="O3" value="1.05" lower_limit="0.98" upper_limit="1.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 9V</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="280"/>
                    <count group_id="O2" value="283"/>
                    <count group_id="O3" value="287"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.40" lower_limit="0.37" upper_limit="0.44"/>
                    <measurement group_id="O2" value="0.41" lower_limit="0.38" upper_limit="0.44"/>
                    <measurement group_id="O3" value="0.48" lower_limit="0.44" upper_limit="0.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="280"/>
                    <count group_id="O2" value="283"/>
                    <count group_id="O3" value="287"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.34" lower_limit="1.22" upper_limit="1.48"/>
                    <measurement group_id="O2" value="1.24" lower_limit="1.12" upper_limit="1.37"/>
                    <measurement group_id="O3" value="2.03" lower_limit="1.83" upper_limit="2.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 18C</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="280"/>
                    <count group_id="O2" value="283"/>
                    <count group_id="O3" value="287"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.28" lower_limit="0.25" upper_limit="0.30"/>
                    <measurement group_id="O2" value="0.41" lower_limit="0.38" upper_limit="0.44"/>
                    <measurement group_id="O3" value="0.34" lower_limit="0.32" upper_limit="0.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 19A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="280"/>
                    <count group_id="O2" value="283"/>
                    <count group_id="O3" value="287"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.40" lower_limit="0.36" upper_limit="0.44"/>
                    <measurement group_id="O2" value="0.41" lower_limit="0.37" upper_limit="0.45"/>
                    <measurement group_id="O3" value="0.50" lower_limit="0.45" upper_limit="0.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 19F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="280"/>
                    <count group_id="O2" value="283"/>
                    <count group_id="O3" value="287"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.43" lower_limit="0.39" upper_limit="0.46"/>
                    <measurement group_id="O2" value="0.47" lower_limit="0.43" upper_limit="0.52"/>
                    <measurement group_id="O3" value="0.57" lower_limit="0.52" upper_limit="0.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 23F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="280"/>
                    <count group_id="O2" value="283"/>
                    <count group_id="O3" value="287"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.29" lower_limit="0.26" upper_limit="0.32"/>
                    <measurement group_id="O2" value="0.37" lower_limit="0.33" upper_limit="0.40"/>
                    <measurement group_id="O3" value="0.32" lower_limit="0.28" upper_limit="0.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 22F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="280"/>
                    <count group_id="O2" value="283"/>
                    <count group_id="O3" value="287"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.30" lower_limit="1.20" upper_limit="1.40"/>
                    <measurement group_id="O2" value="1.23" lower_limit="1.14" upper_limit="1.32"/>
                    <measurement group_id="O3" value="0.05" lower_limit="0.04" upper_limit="0.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 33F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="280"/>
                    <count group_id="O2" value="283"/>
                    <count group_id="O3" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.01" lower_limit="0.92" upper_limit="1.11"/>
                    <measurement group_id="O2" value="0.95" lower_limit="0.87" upper_limit="1.04"/>
                    <measurement group_id="O3" value="0.04" lower_limit="0.04" upper_limit="0.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 1</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>0.69</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>0.76</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 3</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>2.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.75</ci_lower_limit>
            <ci_upper_limit>2.28</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 4</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC 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>0.86</ci_lower_limit>
            <ci_upper_limit>1.07</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 5</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>0.87</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>0.96</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 6A</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>0.57</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.50</ci_lower_limit>
            <ci_upper_limit>0.65</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 6B</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC 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>1.06</ci_lower_limit>
            <ci_upper_limit>1.39</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 7F</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>0.74</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.67</ci_lower_limit>
            <ci_upper_limit>0.82</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 9V</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>0.84</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.74</ci_lower_limit>
            <ci_upper_limit>0.95</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 14</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>0.66</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.58</ci_lower_limit>
            <ci_upper_limit>0.76</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 18C</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>0.80</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>0.90</ci_upper_limit>
            <other_analysis_desc>IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</other_analysis_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 19A</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>0.79</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>0.91</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 19F</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>0.74</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.65</ci_lower_limit>
            <ci_upper_limit>0.85</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 23F</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC 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>0.79</ci_lower_limit>
            <ci_upper_limit>1.07</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>type 22F</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>27.82</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>24.64</ci_lower_limit>
            <ci_upper_limit>31.40</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 33F</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>25.57</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>22.61</ci_lower_limit>
            <ci_upper_limit>28.92</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 1</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC 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>0.69</ci_lower_limit>
            <ci_upper_limit>0.85</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 3</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>2.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.84</ci_lower_limit>
            <ci_upper_limit>2.39</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 4</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC 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>0.85</ci_lower_limit>
            <ci_upper_limit>1.05</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 5</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>0.86</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>0.95</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 6A</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>0.65</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.57</ci_lower_limit>
            <ci_upper_limit>0.74</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 6B</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC 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>0.97</ci_lower_limit>
            <ci_upper_limit>1.28</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 7F</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>0.78</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>0.86</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 9V</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>0.86</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.76</ci_lower_limit>
            <ci_upper_limit>0.97</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 14</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>0.61</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.53</ci_lower_limit>
            <ci_upper_limit>0.70</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 18C</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>1.20</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.07</ci_lower_limit>
            <ci_upper_limit>1.34</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 19A</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>0.82</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>0.94</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 19F</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC 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>0.73</ci_lower_limit>
            <ci_upper_limit>0.94</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 23F</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC 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>0.99</ci_lower_limit>
            <ci_upper_limit>1.35</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 22F</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>26.30</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>23.31</ci_lower_limit>
            <ci_upper_limit>29.68</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 33F</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>24.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>21.32</ci_lower_limit>
            <ci_upper_limit>27.25</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4</title>
        <description>Serotype-specific pneumococcal IgG antibody was assayed using the MSD Pn electrochemiluminescence assay.</description>
        <time_frame>1 month post vaccination 4 (Month 11-14)</time_frame>
        <population>Participants not considered as protocol violators and had data available for endpoint. Violations could include but were not limited to: failure to receive the scheduled correct doses within scheduled timeframe and lack of valid serology results available from 28 to 42 days following the dose being analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>V114 Lot 1</title>
            <description>Infants received a 0.5 mL intramuscular injection of V114 Lot 1 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)</description>
          </group>
          <group group_id="O2">
            <title>V114 Lot 2</title>
            <description>Infants received a 0.5 mL intramuscular injection of V114 Lot 2 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)</description>
          </group>
          <group group_id="O3">
            <title>Prevnar 13™</title>
            <description>Infants received a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4</title>
          <description>Serotype-specific pneumococcal IgG antibody was assayed using the MSD Pn electrochemiluminescence assay.</description>
          <population>Participants not considered as protocol violators and had data available for endpoint. Violations could include but were not limited to: failure to receive the scheduled correct doses within scheduled timeframe and lack of valid serology results available from 28 to 42 days following the dose being analyzed.</population>
          <units>µg/mL</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="329"/>
                <count group_id="O2" value="330"/>
                <count group_id="O3" value="332"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Type 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="273"/>
                    <count group_id="O2" value="265"/>
                    <count group_id="O3" value="277"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.75" lower_limit="1.60" upper_limit="1.92"/>
                    <measurement group_id="O2" value="2.00" lower_limit="1.84" upper_limit="2.19"/>
                    <measurement group_id="O3" value="2.47" lower_limit="2.24" upper_limit="2.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="273"/>
                    <count group_id="O2" value="265"/>
                    <count group_id="O3" value="277"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.12" lower_limit="1.03" upper_limit="1.22"/>
                    <measurement group_id="O2" value="1.16" lower_limit="1.06" upper_limit="1.26"/>
                    <measurement group_id="O3" value="0.78" lower_limit="0.71" upper_limit="0.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="273"/>
                    <count group_id="O2" value="265"/>
                    <count group_id="O3" value="277"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.66" lower_limit="1.49" upper_limit="1.85"/>
                    <measurement group_id="O2" value="1.53" lower_limit="1.37" upper_limit="1.70"/>
                    <measurement group_id="O3" value="1.88" lower_limit="1.69" upper_limit="2.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="273"/>
                    <count group_id="O2" value="265"/>
                    <count group_id="O3" value="277"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.43" lower_limit="3.09" upper_limit="3.80"/>
                    <measurement group_id="O2" value="3.24" lower_limit="2.94" upper_limit="3.57"/>
                    <measurement group_id="O3" value="4.72" lower_limit="4.27" upper_limit="5.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 6A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="273"/>
                    <count group_id="O2" value="265"/>
                    <count group_id="O3" value="277"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.97" lower_limit="4.49" upper_limit="5.51"/>
                    <measurement group_id="O2" value="4.60" lower_limit="4.21" upper_limit="5.04"/>
                    <measurement group_id="O3" value="6.94" lower_limit="6.27" upper_limit="7.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 6B</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="273"/>
                    <count group_id="O2" value="265"/>
                    <count group_id="O3" value="276"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.38" lower_limit="6.68" upper_limit="8.15"/>
                    <measurement group_id="O2" value="5.74" lower_limit="5.24" upper_limit="6.28"/>
                    <measurement group_id="O3" value="6.91" lower_limit="6.25" upper_limit="7.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 7F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="273"/>
                    <count group_id="O2" value="265"/>
                    <count group_id="O3" value="277"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.25" lower_limit="3.87" upper_limit="4.66"/>
                    <measurement group_id="O2" value="4.47" lower_limit="4.07" upper_limit="4.91"/>
                    <measurement group_id="O3" value="6.29" lower_limit="5.73" upper_limit="6.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 9V</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="273"/>
                    <count group_id="O2" value="265"/>
                    <count group_id="O3" value="276"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.43" lower_limit="2.20" upper_limit="2.69"/>
                    <measurement group_id="O2" value="2.71" lower_limit="2.47" upper_limit="2.96"/>
                    <measurement group_id="O3" value="3.53" lower_limit="3.20" upper_limit="3.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="273"/>
                    <count group_id="O2" value="265"/>
                    <count group_id="O3" value="277"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.29" lower_limit="6.54" upper_limit="8.14"/>
                    <measurement group_id="O2" value="7.01" lower_limit="6.30" upper_limit="7.80"/>
                    <measurement group_id="O3" value="8.28" lower_limit="7.47" upper_limit="9.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 18C</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="273"/>
                    <count group_id="O2" value="265"/>
                    <count group_id="O3" value="277"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.75" lower_limit="2.47" upper_limit="3.05"/>
                    <measurement group_id="O2" value="3.15" lower_limit="2.88" upper_limit="3.45"/>
                    <measurement group_id="O3" value="2.94" lower_limit="2.65" upper_limit="3.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 19A</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="273"/>
                    <count group_id="O2" value="265"/>
                    <count group_id="O3" value="277"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.80" lower_limit="5.33" upper_limit="6.31"/>
                    <measurement group_id="O2" value="5.35" lower_limit="4.89" upper_limit="5.87"/>
                    <measurement group_id="O3" value="6.53" lower_limit="5.93" upper_limit="7.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 19F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="273"/>
                    <count group_id="O2" value="265"/>
                    <count group_id="O3" value="277"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.29" lower_limit="4.81" upper_limit="5.82"/>
                    <measurement group_id="O2" value="4.94" lower_limit="4.53" upper_limit="5.39"/>
                    <measurement group_id="O3" value="5.47" lower_limit="4.97" upper_limit="6.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 23F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="273"/>
                    <count group_id="O2" value="265"/>
                    <count group_id="O3" value="277"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.52" lower_limit="2.25" upper_limit="2.83"/>
                    <measurement group_id="O2" value="3.12" lower_limit="2.82" upper_limit="3.44"/>
                    <measurement group_id="O3" value="3.38" lower_limit="3.02" upper_limit="3.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 22F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="273"/>
                    <count group_id="O2" value="265"/>
                    <count group_id="O3" value="277"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.60" lower_limit="7.85" upper_limit="9.42"/>
                    <measurement group_id="O2" value="7.54" lower_limit="6.91" upper_limit="8.23"/>
                    <measurement group_id="O3" value="0.06" lower_limit="0.05" upper_limit="0.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 33F</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="273"/>
                    <count group_id="O2" value="265"/>
                    <count group_id="O3" value="272"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.02" lower_limit="4.59" upper_limit="5.49"/>
                    <measurement group_id="O2" value="4.39" lower_limit="4.06" upper_limit="4.73"/>
                    <measurement group_id="O3" value="0.06" lower_limit="0.05" upper_limit="0.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 1</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>0.71</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>0.81</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 3</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>1.44</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.27</ci_lower_limit>
            <ci_upper_limit>1.63</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 4</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC 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>0.76</ci_lower_limit>
            <ci_upper_limit>1.02</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 5</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>0.73</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.63</ci_lower_limit>
            <ci_upper_limit>0.84</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 6A</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>0.72</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>0.82</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 6B</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC 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>0.93</ci_lower_limit>
            <ci_upper_limit>1.22</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 7F</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>0.67</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.59</ci_lower_limit>
            <ci_upper_limit>0.77</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 9V</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>0.69</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.60</ci_lower_limit>
            <ci_upper_limit>0.79</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 14</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC 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>0.76</ci_lower_limit>
            <ci_upper_limit>1.02</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 18C</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC 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>0.81</ci_lower_limit>
            <ci_upper_limit>1.08</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 19A</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>0.89</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>1.01</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 19F</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC 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>0.85</ci_lower_limit>
            <ci_upper_limit>1.10</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 23F</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>0.75</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.64</ci_lower_limit>
            <ci_upper_limit>0.87</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 22F</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>149.69</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>130.23</ci_lower_limit>
            <ci_upper_limit>172.06</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 33F</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>90.35</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>79.93</ci_lower_limit>
            <ci_upper_limit>102.12</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 1</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>0.81</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>0.93</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 3</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>1.48</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.31</ci_lower_limit>
            <ci_upper_limit>1.68</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 4</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>0.81</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>0.94</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 5</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>0.69</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.60</ci_lower_limit>
            <ci_upper_limit>0.79</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 6A</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>0.66</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.58</ci_lower_limit>
            <ci_upper_limit>0.76</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 6B</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC 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>0.72</ci_lower_limit>
            <ci_upper_limit>0.95</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 7F</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>0.71</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>0.81</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 9V</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC 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>0.67</ci_lower_limit>
            <ci_upper_limit>0.88</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 14</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>0.85</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.73</ci_lower_limit>
            <ci_upper_limit>0.98</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 18C</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC 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>0.93</ci_lower_limit>
            <ci_upper_limit>1.24</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 19A</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>0.82</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>0.93</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 19F</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>0.90</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>1.03</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 23F</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC 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>0.79</ci_lower_limit>
            <ci_upper_limit>1.08</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 22F</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>131.23</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>114.05</ci_lower_limit>
            <ci_upper_limit>151.00</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Type 33F</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMC Ratio</param_type>
            <param_value>78.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>69.82</ci_lower_limit>
            <ci_upper_limit>89.36</ci_upper_limit>
            <estimate_desc>IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months)</time_frame>
      <desc>All enrolled participants that received at least 1 vaccination</desc>
      <group_list>
        <group group_id="E1">
          <title>V114 Lot 1</title>
          <description>Infants received a 0.5 mL intramuscular injection of V114 Lot 1 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)</description>
        </group>
        <group group_id="E2">
          <title>V114 Lot 2</title>
          <description>Infants received a 0.5 mL intramuscular injection of V114 Lot 2 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)</description>
        </group>
        <group group_id="E3">
          <title>Prevnar 13™</title>
          <description>Infants received a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 22.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="350"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="347"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="347"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="350"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="347"/>
                <counts group_id="E3" subjects_affected="15" subjects_at_risk="347"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="350"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="347"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="347"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="350"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="347"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="347"/>
              </event>
              <event>
                <sub_title>Infantile colic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="350"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="347"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="347"/>
              </event>
              <event>
                <sub_title>Intussusception</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="350"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="347"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="347"/>
              </event>
              <event>
                <sub_title>Leukoplakia oral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="350"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="347"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="347"/>
              </event>
              <event>
                <sub_title>Pylorospasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="350"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="347"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="347"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="350"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="347"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="347"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="350"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="347"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="347"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Milk allergy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="350"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="347"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="347"/>
              </event>
              <event>
                <sub_title>Serum sickness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="350"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="347"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="347"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchiolitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="350"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="347"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="347"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="350"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="347"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="347"/>
              </event>
              <event>
                <sub_title>Croup infectious</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="350"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="347"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="347"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="350"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="347"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="347"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="350"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="347"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="347"/>
              </event>
              <event>
                <sub_title>H1N1 influenza</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="350"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="347"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="347"/>
              </event>
              <event>
                <sub_title>Haemophilus bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="350"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="347"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="347"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="350"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="347"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="347"/>
              </event>
              <event>
                <sub_title>Otitis media acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="350"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="347"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="347"/>
              </event>
              <event>
                <sub_title>Periorbital cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="350"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="347"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="347"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="350"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="347"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="347"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="350"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="347"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="347"/>
              </event>
              <event>
                <sub_title>Respiratory syncytial virus bronchiolitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="350"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="347"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="347"/>
              </event>
              <event>
                <sub_title>Rhinovirus infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="350"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="347"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="347"/>
              </event>
              <event>
                <sub_title>Salmonellosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="350"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="347"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="347"/>
              </event>
              <event>
                <sub_title>Streptococcal bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="350"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="347"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="347"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="350"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="347"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="347"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Burns second degree</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="350"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="347"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="347"/>
              </event>
              <event>
                <sub_title>Concussion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="350"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="347"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="347"/>
              </event>
              <event>
                <sub_title>Skull fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="350"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="347"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="347"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="350"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="347"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="347"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Febrile convulsion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="350"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="347"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="347"/>
              </event>
              <event>
                <sub_title>Fontanelle bulging</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="350"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="347"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="347"/>
              </event>
              <event>
                <sub_title>Infantile spasms</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="350"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="347"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="347"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="350"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="347"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="347"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Testicular atrophy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="350"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="347"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="347"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Apparent life threatening event</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="350"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="347"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="347"/>
              </event>
              <event>
                <sub_title>Obliterative bronchiolitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="350"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="347"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="347"/>
              </event>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="350"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="347"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="347"/>
              </event>
              <event>
                <sub_title>Respiratory distress</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="350"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="347"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="347"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Purpura</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="350"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="347"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="347"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 22.0</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="333" subjects_at_risk="350"/>
                <counts group_id="E2" subjects_affected="337" subjects_at_risk="347"/>
                <counts group_id="E3" subjects_affected="330" subjects_at_risk="347"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="54" subjects_affected="39" subjects_at_risk="350"/>
                <counts group_id="E2" events="61" subjects_affected="44" subjects_at_risk="347"/>
                <counts group_id="E3" events="59" subjects_affected="52" subjects_at_risk="347"/>
              </event>
              <event>
                <sub_title>Teething</sub_title>
                <counts group_id="E1" events="23" subjects_affected="17" subjects_at_risk="350"/>
                <counts group_id="E2" events="38" subjects_affected="26" subjects_at_risk="347"/>
                <counts group_id="E3" events="22" subjects_affected="19" subjects_at_risk="347"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="31" subjects_affected="27" subjects_at_risk="350"/>
                <counts group_id="E2" events="24" subjects_affected="23" subjects_at_risk="347"/>
                <counts group_id="E3" events="45" subjects_affected="34" subjects_at_risk="347"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" events="256" subjects_affected="151" subjects_at_risk="350"/>
                <counts group_id="E2" events="280" subjects_affected="164" subjects_at_risk="347"/>
                <counts group_id="E3" events="259" subjects_affected="153" subjects_at_risk="347"/>
              </event>
              <event>
                <sub_title>Injection site induration</sub_title>
                <counts group_id="E1" events="206" subjects_affected="117" subjects_at_risk="350"/>
                <counts group_id="E2" events="195" subjects_affected="109" subjects_at_risk="347"/>
                <counts group_id="E3" events="200" subjects_affected="113" subjects_at_risk="347"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" events="385" subjects_affected="198" subjects_at_risk="350"/>
                <counts group_id="E2" events="393" subjects_affected="200" subjects_at_risk="347"/>
                <counts group_id="E3" events="327" subjects_affected="162" subjects_at_risk="347"/>
              </event>
              <event>
                <sub_title>Injection site swelling</sub_title>
                <counts group_id="E1" events="157" subjects_affected="98" subjects_at_risk="350"/>
                <counts group_id="E2" events="176" subjects_affected="100" subjects_at_risk="347"/>
                <counts group_id="E3" events="142" subjects_affected="91" subjects_at_risk="347"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="199" subjects_affected="115" subjects_at_risk="350"/>
                <counts group_id="E2" events="221" subjects_affected="128" subjects_at_risk="347"/>
                <counts group_id="E3" events="252" subjects_affected="141" subjects_at_risk="347"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="27" subjects_affected="25" subjects_at_risk="350"/>
                <counts group_id="E2" events="23" subjects_affected="20" subjects_at_risk="347"/>
                <counts group_id="E3" events="22" subjects_affected="19" subjects_at_risk="347"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" events="16" subjects_affected="16" subjects_at_risk="350"/>
                <counts group_id="E2" events="16" subjects_affected="16" subjects_at_risk="347"/>
                <counts group_id="E3" events="18" subjects_affected="18" subjects_at_risk="347"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="27" subjects_affected="26" subjects_at_risk="350"/>
                <counts group_id="E2" events="29" subjects_affected="24" subjects_at_risk="347"/>
                <counts group_id="E3" events="42" subjects_affected="34" subjects_at_risk="347"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="303" subjects_affected="158" subjects_at_risk="350"/>
                <counts group_id="E2" events="332" subjects_affected="175" subjects_at_risk="347"/>
                <counts group_id="E3" events="289" subjects_affected="154" subjects_at_risk="347"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="564" subjects_affected="221" subjects_at_risk="350"/>
                <counts group_id="E2" events="661" subjects_affected="241" subjects_at_risk="347"/>
                <counts group_id="E3" events="573" subjects_affected="233" subjects_at_risk="347"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" events="1118" subjects_affected="295" subjects_at_risk="350"/>
                <counts group_id="E2" events="1255" subjects_affected="301" subjects_at_risk="347"/>
                <counts group_id="E3" events="1113" subjects_affected="294" subjects_at_risk="347"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="31" subjects_affected="26" subjects_at_risk="350"/>
                <counts group_id="E2" events="23" subjects_affected="19" subjects_at_risk="347"/>
                <counts group_id="E3" events="19" subjects_affected="19" subjects_at_risk="347"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" events="28" subjects_affected="21" subjects_at_risk="350"/>
                <counts group_id="E2" events="15" subjects_affected="15" subjects_at_risk="347"/>
                <counts group_id="E3" events="10" subjects_affected="9" subjects_at_risk="347"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" events="16" subjects_affected="15" subjects_at_risk="350"/>
                <counts group_id="E2" events="29" subjects_affected="21" subjects_at_risk="347"/>
                <counts group_id="E3" events="16" subjects_affected="16" subjects_at_risk="347"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Senior Vice President, Global Clinical Development</name_or_title>
      <organization>Merck Sharp &amp; Dohme Corp.</organization>
      <phone>1-800-672-6372</phone>
      <email>ClinicalTrialsDisclosure@merck.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02987972
org study id: V114-008
secondary id: 2016-001117-25
nct id: NCT02987972
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study is designed to evaluate the safety, tolerability, and immunogenicity of two
      different lots of V114 in healthy infants 6 to 12 weeks (>=42 days to <=90 days) of age. The
      primary hypothesis of the study is that the proportion of participants receiving V114 who
      have serotype specific IgG >=0.35 mcg/mL for each of pneumococcal serotypes 1, 3, 4, 5, 6A,
      6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F at 1 month after Dose 3 is non-inferior to that for
      recipients of Prevnar 13™.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
measure: Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3
time frame: 1 month post vaccination 3 (Month 5)
description: Serotype-specific pneumococcal IgG antibody was measured using the Meso-Scale Discovery (MSD) Pneumococcal electrochemiluminescence assay (Pn ECL). The percentage of participants with serotype-specific IgG ≥0.35 µg/mL was summarized for each serotype.
measure: Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3
time frame: 1 month post Vaccination 3 (Month 5)
description: Serotype-specific pneumococcal IgG antibody will be assayed using the Meso-Scale Discovery (MSD) Pn electrochemiluminescence assay. The geometric mean concentration (GMC) of serotype-specific IgG will be assessed.
measure: Percentage of Participants Who Experience at Least 1 Adverse Event
time frame: Up to 1 month post Vaccination 4 (up to 14 months)
description: An adverse event (AE) is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants with one or more AEs was assessed.
measure: Percentage of Participants Who Discontinued From the Study Due to an Adverse Event
time frame: Up to 1 month post Vaccination 4 (up to 14 months)
description: The percentage of participants who discontinued the study because of an AE (as defined above) was assessed.
measure: Percentage of Participants With a Solicited Injection-site Adverse Event
time frame: Up to 14 days post any vaccination
description: Injection-site AEs solicited on the Vaccine Report Card were redness, swelling, hard lump, and pain/tenderness. The percentage of participants with 1 or more solicited injection-site AEs was assessed.
measure: Percentage of Participants With a Solicited Systemic Adverse Event
time frame: Up to 14 days post any vaccination
description: Systemic AEs solicited on the Vaccine Report Card were fever, irritability, drowsiness, hive/welts, and appetite loss. The percentage of participants with 1 or more solicited systemic AEs was assessed.
measure: Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4
time frame: Before Vaccination 4 (Month 10 to 13)
description: Serotype-specific pneumococcal IgG antibody was assayed using the MSD Pn electrochemiluminescence assay.
measure: Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4
time frame: 1 month post vaccination 4 (Month 11-14)
description: Serotype-specific pneumococcal IgG antibody was assayed using the MSD Pn electrochemiluminescence assay.
arm group label: V114 Lot 1
arm group type: Experimental
description: Infants will receive a 0.5 mL intramuscular injection of V114 Lot 1 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)
arm group label: V114 Lot 2
arm group type: Experimental
description: Infants will receive a 0.5 mL intramuscular injection of V114 Lot 2 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)
arm group label: Prevnar 13™
arm group type: Active Comparator
description: Infants will receive a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)
intervention type: Biological
intervention name: V114 Lot 1
description: Lot 1: Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose
arm group label: V114 Lot 1
other name: V114-1
intervention type: Biological
intervention name: V114 Lot 2
description: Lot 2: Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose
arm group label: V114 Lot 2
other name: V114-2
intervention type: Biological
intervention name: Prevnar 13™
description: Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) in each 0.5 ml dose
arm group label: Prevnar 13™
criteria: 
gender: All
minimum age: 6 Weeks
maximum age: 12 Weeks
healthy volunteers: Accepts Healthy Volunteers
last name: Medical Director
role: Study Director
affiliation: Merck Sharp & Dohme LLC
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country: Canada
country: Denmark
country: Finland
country: Israel
country: Spain
country: United States
responsible party type: Sponsor
mesh term: Pneumococcal Infections
mesh term: Heptavalent Pneumococcal Conjugate Vaccine
sharing ipd: Yes
ipd description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
ipd url: http://engagezone.msd.com/ds_documentation.php
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