<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/NCT02184572</url>
  </required_header>
  <id_info>
    <org_study_id>115650</org_study_id>
    <secondary_id>2011-006161-18</secondary_id>
    <nct_id>NCT02184572</nct_id>
  </id_info>
  <brief_title>Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' Measles, Mumps and Rubella (MMR) Vaccine (209762) Compared to Merck &amp; Co., Inc.'s MMR Vaccine in Healthy Children 12 to 15 Months of Age</brief_title>
  <official_title>Safety and Immunogenicity Study of GSK Biologicals' Measles-mumps-rubella (MMR) Vaccine (209762) Comparing Immunogenicity and Safety to Merck &amp; Co., Inc.'s MMR Vaccine, in Healthy Children 12 to 15 Months of Age</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals'&#xD;
      trivalent MMR (Priorix), comparing it to Merck's MMR vaccine (M-M-R II), which is approved&#xD;
      for use in the US in healthy children 12 to 15 months of age.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will evaluate the safety of GSK's trivalent MMR vaccine (referred to as INV_MMR&#xD;
      vaccine) at a potency that will be used to define maximum release limits for the INV_MMR in&#xD;
      comparison to the US standard of care (M-M-R II/ M-M-R VaxPro vaccine referred to as COM_MMR&#xD;
      vaccine). In order to obtain more representative data on the comparator vaccine, the COM_MMR&#xD;
      used in this study will consist of two lots designated COM_MMR_L1 and COM_MMR_L2. Throughout&#xD;
      the study COM_MMR_L1 and COM_MMR_L2 will be analyzed as pooled lots. This study is intended&#xD;
      to support licensure of GSK's MMR vaccine in the US.&#xD;
&#xD;
      All children will receive Varivax and Havrix vaccines, concomitantly with MMR containing&#xD;
      vaccine at 12 to 15 months of age. Prevnar 13 will be administered only to US children. At&#xD;
      the end of the study, GSK will provide a second dose of Havrix and/or varicella vaccine to&#xD;
      participants enrolled in selected non-US countries if local health departments do not&#xD;
      routinely provide hepatitis A and varicella vaccination. The second dose of Havrix and&#xD;
      varicella vaccine is not part of the study procedures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 25, 2014</start_date>
  <completion_date type="Actual">December 22, 2015</completion_date>
  <primary_completion_date type="Actual">August 14, 2015</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Subjects Reporting Fever After MMR (Priorix or M-M-R II/M-M-R VaxPro [Lot 1 or Lot 2]) Vaccination</measure>
    <time_frame>During Day 5 to Day 12 post-vaccination period</time_frame>
    <description>Fever was assessed for temperature equal to/above (≥) 38.0°C and above (&gt;) 39.0°C. The safety profile for fever was assessed based on the group difference (INV_MMR minus COM_MMR) in incidence of fever equal to or below the cut-off value.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value</measure>
    <time_frame>At Day 42 post vaccination</time_frame>
    <description>Seroresponse was defined as post-vaccination anti-measles virus antibody concentration greater than or equal to [≥] 200 milli International Units per milliliter [mIU/mL] (Enzyme-Linked Immunosorbent Assay [ELISA], Enzygnost) among subjects who were seronegative (antibody concentration less than [&lt;] 150 mIU/mL) before vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-measles Virus Antibody Concentrations</measure>
    <time_frame>At Day 42 post vaccination</time_frame>
    <description>Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. Analyses included initially seronegative subjects only.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value</measure>
    <time_frame>At Day 42 post vaccination</time_frame>
    <description>Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 10 ELISA Unit per milliliter [EU/mL] (ELISA, Pharmaceutical Product Development, Inc.[PPD]) among subjects who were seronegative (antibody concentration &lt; 5 EU/mL) before vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-mumps Virus Antibody Concentrations</measure>
    <time_frame>At Day 42 post vaccination</time_frame>
    <description>Antibody concentrations were expressed as GMCs in EU/mL. Analyses included initially seronegative subjects only.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value</measure>
    <time_frame>At Day 42 post vaccination</time_frame>
    <description>Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥ 10 International Unit per milliliter [IU/mL] (ELISA, Enzygnost) among subjects who were seronegative (antibody concentration &lt; 4 IU/mL) before vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-rubella Virus Antibody Concentrations</measure>
    <time_frame>At Day 42 post vaccination</time_frame>
    <description>Antibody concentrations were expressed as GMCs in IU/mL. Analyses included initially seronegative subjects only.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Any Solicited Local Adverse Events (AEs)</measure>
    <time_frame>During the 4-day (Days 0-3) post-vaccination period</time_frame>
    <description>Assessed solicited local AEs were injection site pain, redness and swelling. Any = Occurrence of AE regardless of intensity grade or relation to vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Any Solicited General AEs</measure>
    <time_frame>During the 15-day (Days 0-14) post-vaccination period</time_frame>
    <description>Assessed solicited general AEs were drowsiness, irritability/fussiness and loss of appetite. Any = Occurrence of AE regardless of intensity grade or relation to vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Any Fever</measure>
    <time_frame>During the 43-day (Days 0-42) post-vaccination period</time_frame>
    <description>Any fever (≥ 38°C) = Occurrence of fever regardless of intensity grade or relation to vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Any Rash</measure>
    <time_frame>During the 43-day (Days 0-42) post-vaccination period</time_frame>
    <description>Any rash = Occurrence of AE regardless of intensity grade or relation to vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting MMR Specific Solicited General AEs</measure>
    <time_frame>During the 43-day (Days 0-42) post-vaccination period</time_frame>
    <description>Assessed MMR specific solicited general AEs were parotid gland swelling and any suspected signs of meningism including febrile convulsions. Any = Occurrence of AE regardless of intensity grade or relation to vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Any Unsolicited AEs</measure>
    <time_frame>During the 43-day (Days 0-42) post-vaccination period</time_frame>
    <description>Unsolicited AE included any AE reported in addition to those solicited during the clinical study and any 'solicited' AE with onset outside the specified period of follow-up for solicited AEs. Any = Occurrence of AE regardless of intensity grade or relation to vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting AEs of Specific Interest</measure>
    <time_frame>Day 0 through the end of the study (Day 180)</time_frame>
    <description>AEs of specific interest included new onset chronic disease (NOCD) (e.g., autoimmune disorders, asthma, type I diabetes, vasculitis, celiac disease, conditions associated with sub-acute or chronic thrombocytopenia and allergies) and AEs prompting emergency room (ER) visits.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Any Serious Adverse Events (SAEs)</measure>
    <time_frame>Day 0 through the end of the study (Day 180)</time_frame>
    <description>SAE included any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization or resulted in disability/incapacity. Any = Occurrence of AE regardless of intensity grade or relation to vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Measles-like Illness</measure>
    <time_frame>During Day 5 to Day 12 post-vaccination period</time_frame>
    <description>Measles-like illness was defined as the occurrence of the following signs/symptoms in the absence of another confirmed diagnosis:&#xD;
maculopapular rash (includes measles/rubella-like rash), fever (≥ 38°C) and at least one of the symptoms: cough, coryza (runny nose), conjunctivitis or diarrhea, with fever or rash. Other event must be one of cough, coryza, conjunctivitis, or diarrhea.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1742</enrollment>
  <condition>Measles; Mumps; Rubella</condition>
  <condition>Measles-Mumps-Rubella Vaccine</condition>
  <arm_group>
    <arm_group_label>INV_MMR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects receive 1 dose of the study vaccine Priorix co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also receive Prevnar 13 at Day 0.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>COM_MMR</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects receive 1 dose of the licensed vaccine M-M-R II or M-M-R VaxPro Lot 1 or Lot 2 co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also receive Prevnar 13 at Day 0.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Priorix</intervention_name>
    <description>1 dose administered subcutaneously in the triceps region of left arm at Day 0</description>
    <arm_group_label>INV_MMR</arm_group_label>
    <other_name>GSK Biologicals' live attenuated measles</other_name>
    <other_name>mumps and rubella (MMR) vaccine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>M-M-R II</intervention_name>
    <description>1 dose administered subcutaneously in the triceps region of left arm at Day 0</description>
    <arm_group_label>COM_MMR</arm_group_label>
    <other_name>MMR vaccine live (M-M R II</other_name>
    <other_name>Merck &amp; Co.</other_name>
    <other_name>Inc.</other_name>
    <other_name>or M-M-R VaxPro</other_name>
    <other_name>Sanofi Pasteur/Merck Sharp and Dohme [SPMSD])</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Varivax</intervention_name>
    <description>1 dose administered subcutaneously in the triceps region of right arm at Day 0</description>
    <arm_group_label>COM_MMR</arm_group_label>
    <arm_group_label>INV_MMR</arm_group_label>
    <other_name>Merck &amp; Co. Inc.'s Varicella virus vaccine</other_name>
    <other_name>live</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Havrix</intervention_name>
    <description>1 dose administered intramuscularly in the anterolateral region of the right thigh at Day 0</description>
    <arm_group_label>COM_MMR</arm_group_label>
    <arm_group_label>INV_MMR</arm_group_label>
    <other_name>GSK Biologicals' Hepatitis A vaccine</other_name>
    <other_name>inactivated</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Prevnar 13</intervention_name>
    <description>1 dose administered intramuscularly in the anterolateral region of the left thigh at Day 0 to subjects recruited in US</description>
    <arm_group_label>COM_MMR</arm_group_label>
    <arm_group_label>INV_MMR</arm_group_label>
    <other_name>Pfizer Inc.'s Pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female child between 12 and 15 months of age (e.g., from the 1 year birthday&#xD;
             until the day before age 16 months) at the time of vaccination.&#xD;
&#xD;
          -  Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion&#xD;
             of the investigator, can and will comply, with the requirements of the protocol.&#xD;
&#xD;
          -  Written informed consent obtained from the parent(s)/LAR(s) of the child.&#xD;
&#xD;
          -  Child is in stable health as determined by investigator's clinical examination and&#xD;
             assessment of child's medical history.&#xD;
&#xD;
          -  For US children only: a child who received all routine vaccinations as per ACIP&#xD;
             recommendations prior to study entry: completion of hepatitis B and rotavirus series&#xD;
             and completion of the primary series of diphtheria, tetanus, pertussis, poliovirus,&#xD;
             Haemophilus influenzae type b (Hib) and pneumococcal vaccines. The 3-dose infant&#xD;
             series of Prevnar 13 should be completed at least 60 days prior to study vaccination.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Child in care.&#xD;
&#xD;
          -  Use of any investigational or non-registered product (drug or vaccine) other than the&#xD;
             study vaccine(s) during the period starting 30 days before the day of study&#xD;
             vaccination (i.e., 30 days prior to Day 0) or planned use during the entire study&#xD;
             period.&#xD;
&#xD;
          -  Concurrently participating in another clinical study, in which the child has been or&#xD;
             will be exposed to an investigational or a non-investigational product (pharmaceutical&#xD;
             product or device).&#xD;
&#xD;
          -  Chronic administration (defined as 14 or more consecutive days) of immunosuppressants,&#xD;
             or other immune-modifying drugs during the period starting 180 days prior to the study&#xD;
             vaccination at Visit 1 or any planned administration of immunosuppressive and&#xD;
             immune-modifying drugs during the entire study.&#xD;
&#xD;
               -  For corticosteroids, this will mean prednisone ≥0.5 mg/kg/day or equivalent.&#xD;
&#xD;
               -  Inhaled and topical steroids are allowed.&#xD;
&#xD;
          -  Planned administration/ administration of a vaccine not foreseen by the study protocol&#xD;
             during the period starting 30 days prior to the day of study vaccination at Visit 1&#xD;
             and ending at Visit 2. Please Note:&#xD;
&#xD;
               -  Inactivated influenza (Flu) vaccine and monovalent Haemophilus influenzae type b&#xD;
                  conjugate vaccine (Hib) vaccines may be given at any time, including the day of&#xD;
                  study vaccination (Flu and Hib vaccines must be administered at a different&#xD;
                  location than the study vaccine/s).&#xD;
&#xD;
               -  Any other age appropriate vaccine may be given starting at Visit 2 and anytime&#xD;
                  thereafter.&#xD;
&#xD;
          -  Administration of immunoglobulins and/or any blood products during the period starting&#xD;
             180 days before the study vaccination at Visit 1 or planned administration from the&#xD;
             date of vaccination through the immunogenicity evaluation at Visit 2.&#xD;
&#xD;
          -  History of measles, mumps, rubella, varicella/zoster and/or hepatitis A disease.&#xD;
&#xD;
          -  Known exposure to measles, mumps, rubella and/or varicella/zoster during the period&#xD;
             starting within 30 days prior to first study vaccination.&#xD;
&#xD;
          -  Previous vaccination against measles, mumps, rubella, hepatitis A and/or varicella&#xD;
             virus.&#xD;
&#xD;
          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on&#xD;
             medical history and physical examination (no laboratory testing required).&#xD;
&#xD;
          -  Blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms&#xD;
             affecting the bone marrow or lymphatic systems.&#xD;
&#xD;
          -  A family history of congenital or hereditary immunodeficiency.&#xD;
&#xD;
          -  History of allergic disease or reactions likely to be exacerbated by any component of&#xD;
             the vaccines, including hypersensitivity to neomycin, latex or gelatin.&#xD;
&#xD;
          -  Acute disease at the time of enrollment. (Acute disease is defined as the presence of&#xD;
             a moderate or severe illness with or without fever). Fever is defined as temperature&#xD;
             ≥38.0°C/100.4°F by any age appropriate route. All vaccines can be administered to&#xD;
             persons with a minor illness such as diarrhea, mild upper respiratory infection&#xD;
             without fever.&#xD;
&#xD;
          -  Active untreated tuberculosis based on medical history.&#xD;
&#xD;
          -  Any other condition which, in the opinion of the investigator, prevents the child from&#xD;
             participating in the study.&#xD;
&#xD;
          -  For US children only: a child that previously received a fourth dose of PCV-13&#xD;
             vaccine.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Months</minimum_age>
    <maximum_age>15 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85741</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Fayetteville</city>
        <state>Arkansas</state>
        <zip>72703</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Jonesboro</city>
        <state>Arkansas</state>
        <zip>72401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Baldwin Park</city>
        <state>California</state>
        <zip>91706</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Daly City</city>
        <state>California</state>
        <zip>94015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93726</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hayward</city>
        <state>California</state>
        <zip>94545</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <zip>94611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Paramount</city>
        <state>California</state>
        <zip>90723</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Pleasanton</city>
        <state>California</state>
        <zip>94588</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Roseville</city>
        <state>California</state>
        <zip>95661</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95815</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95823</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>San Jose</city>
        <state>California</state>
        <zip>95119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Santa Clara</city>
        <state>California</state>
        <zip>95051</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Walnut Creek</city>
        <state>California</state>
        <zip>94596</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80922</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Norwich</city>
        <state>Connecticut</state>
        <zip>06360</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Miami Lakes</city>
        <state>Florida</state>
        <zip>33014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Nampa</city>
        <state>Idaho</state>
        <zip>83686</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Augusta</city>
        <state>Kansas</state>
        <zip>67010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Newton</city>
        <state>Kansas</state>
        <zip>67114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Topeka</city>
        <state>Kansas</state>
        <zip>66604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bardstown</city>
        <state>Kentucky</state>
        <zip>40004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bossier City</city>
        <state>Louisiana</state>
        <zip>71111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Metairie</city>
        <state>Louisiana</state>
        <zip>70006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Columbia</city>
        <state>Maryland</state>
        <zip>21045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Frederick</city>
        <state>Maryland</state>
        <zip>21702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Niles</city>
        <state>Michigan</state>
        <zip>49120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Stevensville</city>
        <state>Michigan</state>
        <zip>49127</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68516</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Binghamton</city>
        <state>New York</state>
        <zip>13901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Asheboro</city>
        <state>North Carolina</state>
        <zip>27203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Boone</city>
        <state>North Carolina</state>
        <zip>28607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Clyde</city>
        <state>North Carolina</state>
        <zip>28721</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Mandan</city>
        <state>North Dakota</state>
        <zip>58501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45414</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Erie</city>
        <state>Pennsylvania</state>
        <zip>16505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sellersville</city>
        <state>Pennsylvania</state>
        <zip>18960</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Cheraw</city>
        <state>South Carolina</state>
        <zip>29520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Spartanburg</city>
        <state>South Carolina</state>
        <zip>29303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Watertown</city>
        <state>South Dakota</state>
        <zip>57201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kingsport</city>
        <state>Tennessee</state>
        <zip>37660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>League City</city>
        <state>Texas</state>
        <zip>77573</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tomball</city>
        <state>Texas</state>
        <zip>77375</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Layton</city>
        <state>Utah</state>
        <zip>84041</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Orem</city>
        <state>Utah</state>
        <zip>84057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Payson</city>
        <state>Utah</state>
        <zip>84651</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Provo</city>
        <state>Utah</state>
        <zip>84604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Roy</city>
        <state>Utah</state>
        <zip>84067</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Saint George</city>
        <state>Utah</state>
        <zip>84790</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>South Jordan</city>
        <state>Utah</state>
        <zip>84095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Syracuse</city>
        <state>Utah</state>
        <zip>84075</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>West Jordan</city>
        <state>Utah</state>
        <zip>84088</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ellensburg</city>
        <state>Washington</state>
        <zip>98926</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Huntington</city>
        <state>West Virginia</state>
        <zip>25701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Marshfield</city>
        <state>Wisconsin</state>
        <zip>54449</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Monroe</city>
        <state>Wisconsin</state>
        <zip>53566</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tartu</city>
        <zip>50106</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Espoo</city>
        <zip>02230</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Helsinki</city>
        <zip>00100</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Helsinki</city>
        <zip>00930</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Jarvenpaa</city>
        <zip>04400</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tampere</city>
        <zip>33100</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Turku</city>
        <zip>20520</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Guayama</city>
        <zip>00784</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ponce</city>
        <zip>00716</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>San Juan</city>
        <zip>00936-5067</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Taichung</city>
        <zip>404</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Taichung</city>
        <zip>407</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Taipei</city>
        <zip>104</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Taoyuan</city>
        <zip>333</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Estonia</country>
    <country>Finland</country>
    <country>Puerto Rico</country>
    <country>Taiwan</country>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>MMR-162 Study Group. Safety and immunogenicity of an upper-range release titer measles-mumps-rubella vaccine in children vaccinated at 12 to 15 months of age: a phase III, randomized study. Hum Vaccin Immunother. 2018;14(12):2921-2931. doi: 10.1080/21645515.2018.1502527. Epub 2018 Aug 29.</citation>
    <PMID>30118386</PMID>
  </reference>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>July 3, 2014</study_first_submitted>
  <study_first_submitted_qc>July 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <results_first_submitted>December 27, 2016</results_first_submitted>
  <results_first_submitted_qc>June 1, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">July 3, 2018</results_first_posted>
  <disposition_first_submitted>September 22, 2016</disposition_first_submitted>
  <disposition_first_submitted_qc>September 22, 2016</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">October 19, 2016</disposition_first_posted>
  <last_update_submitted>December 15, 2020</last_update_submitted>
  <last_update_submitted_qc>December 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 7, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Rubella</keyword>
  <keyword>Healthy children</keyword>
  <keyword>Measles</keyword>
  <keyword>Safety</keyword>
  <keyword>Mumps</keyword>
  <keyword>12 to 15 months</keyword>
  <keyword>Immunogenicity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Measles</mesh_term>
    <mesh_term>Rubella</mesh_term>
    <mesh_term>Mumps</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaccines</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>6 subjects from 1742 were allocated subject number but no study vaccine was administered. Therefore, the number of subjects started in 1736.</recruitment_details>
      <pre_assignment_details>US sub-cohort: Subjects recruited in US received INV_MMR (Priorix) or COM_MMR (M-M-R II/M-M-R VaxPro) co-administered with Varivax, Havrix &amp; Prevnar 13 vaccines (Day 0). Non-US sub-cohort: Subjects recruited outside the US received INV_MMR (Priorix) or COM_MMR (M-M-R II/M-M-R VaxPro) co-administered with Varivax &amp; Havrix vaccines (Day 0).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>INV_MMR</title>
          <description>Subjects received 1 dose of the study vaccine Priorix co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.</description>
        </group>
        <group group_id="P2">
          <title>COM_MMR</title>
          <description>Subjects received 1 dose of the licensed vaccine M-M-R II or M-M-R VaxPro Lot 1 or Lot 2 co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1164"/>
                <participants group_id="P2" count="572"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1117"/>
                <participants group_id="P2" count="542"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="47"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Family Out Of Country Until 9/29/2015</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Loss Of Kaiser Insurance</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>2nd blooddraw &amp; diary card incomplete</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Traveling Outside The Country</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>INV_MMR</title>
          <description>Subjects received 1 dose of the study vaccine Priorix co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.</description>
        </group>
        <group group_id="B2">
          <title>COM_MMR</title>
          <description>Subjects received 1 dose of the licensed vaccine M-M-R II or M-M-R VaxPro Lot 1 or Lot 2 co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1164"/>
            <count group_id="B2" value="572"/>
            <count group_id="B3" value="1736"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12.3" spread="0.7"/>
                    <measurement group_id="B2" value="12.3" spread="0.7"/>
                    <measurement group_id="B3" value="12.3" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="551"/>
                    <measurement group_id="B2" value="270"/>
                    <measurement group_id="B3" value="821"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="613"/>
                    <measurement group_id="B2" value="302"/>
                    <measurement group_id="B3" value="915"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>African Heritage / African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="102"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>American Indian or Alaskan Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian - Central/South Asian Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian - East Asian Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="131"/>
                    <measurement group_id="B2" value="65"/>
                    <measurement group_id="B3" value="196"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian - Japanese Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian - South East Asian Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native Hawaiian or Other Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White - Arabic / North African Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White - Caucasian / European Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="808"/>
                    <measurement group_id="B2" value="385"/>
                    <measurement group_id="B3" value="1193"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="89"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="136"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Subjects Reporting Fever After MMR (Priorix or M-M-R II/M-M-R VaxPro [Lot 1 or Lot 2]) Vaccination</title>
        <description>Fever was assessed for temperature equal to/above (≥) 38.0°C and above (&gt;) 39.0°C. The safety profile for fever was assessed based on the group difference (INV_MMR minus COM_MMR) in incidence of fever equal to or below the cut-off value.</description>
        <time_frame>During Day 5 to Day 12 post-vaccination period</time_frame>
        <population>Analysis was performed on Total Vaccinated cohort (TVC) which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented.</population>
        <group_list>
          <group group_id="O1">
            <title>INV_MMR Group</title>
            <description>Subjects received 1 dose of the study vaccine Priorix co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.</description>
          </group>
          <group group_id="O2">
            <title>COM_MMR Group</title>
            <description>Subjects received 1 dose of the licensed vaccine M-M-R II or M-M-R VaxPro Lot 1 or Lot 2 co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Fever After MMR (Priorix or M-M-R II/M-M-R VaxPro [Lot 1 or Lot 2]) Vaccination</title>
          <description>Fever was assessed for temperature equal to/above (≥) 38.0°C and above (&gt;) 39.0°C. The safety profile for fever was assessed based on the group difference (INV_MMR minus COM_MMR) in incidence of fever equal to or below the cut-off value.</description>
          <population>Analysis was performed on Total Vaccinated cohort (TVC) which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1126"/>
                <count group_id="O2" value="555"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>&gt; 39.0°C</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 38.0°C</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="205"/>
                    <measurement group_id="O2" value="95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Difference between groups (INV_MMR Group minus COM_MMR Group) in incidence of fever &gt; 39.0°C.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence (legacy)</non_inferiority_type>
            <non_inferiority_desc>The upper limit of the 2-sided standardised asymptotic 95% Confidence Interval (CI) for the group difference (INV_MMR minus COM_MMR) in incidence of fever ≥ 39.0°C (≥ 102.2°F) should be equal to or below 5%.</non_inferiority_desc>
            <param_type>Difference in incidence of fever</param_type>
            <param_value>1.11</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.93</ci_lower_limit>
            <ci_upper_limit>2.89</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Difference between groups (INV_MMR Group minus COM_MMR Group) in incidence of fever &gt; 38.0°C.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence (legacy)</non_inferiority_type>
            <non_inferiority_desc>The upper limit of the 2-sided standardised asymptotic 95% CI for the group difference (INV_MMR minus COM_MMR) in incidence of fever ≥ 38.0°C (≥ 100.4°F) should be equal to or below 10%.</non_inferiority_desc>
            <param_type>Difference in incidence of fever</param_type>
            <param_value>1.09</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.89</ci_lower_limit>
            <ci_upper_limit>4.85</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value</title>
        <description>Seroresponse was defined as post-vaccination anti-measles virus antibody concentration greater than or equal to [≥] 200 milli International Units per milliliter [mIU/mL] (Enzyme-Linked Immunosorbent Assay [ELISA], Enzygnost) among subjects who were seronegative (antibody concentration less than [&lt;] 150 mIU/mL) before vaccination.</description>
        <time_frame>At Day 42 post vaccination</time_frame>
        <population>According to Protocol (ATP) cohort for immunogenicity: included all eligible subjects with pre and post-vaccination serology results available for at least one vaccine components of measles, mumps or rubella, who did not meet any elimination criteria up to the Visit 2 blood sample and who complied with the post dose blood sample schedule.</population>
        <group_list>
          <group group_id="O1">
            <title>INV_MMR Group</title>
            <description>Subjects received 1 dose of the study vaccine Priorix co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.</description>
          </group>
          <group group_id="O2">
            <title>COM_MMR Group</title>
            <description>Subjects received 1 dose of the licensed vaccine M-M-R II or M-M-R VaxPro Lot 1 or Lot 2 co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value</title>
          <description>Seroresponse was defined as post-vaccination anti-measles virus antibody concentration greater than or equal to [≥] 200 milli International Units per milliliter [mIU/mL] (Enzyme-Linked Immunosorbent Assay [ELISA], Enzygnost) among subjects who were seronegative (antibody concentration less than [&lt;] 150 mIU/mL) before vaccination.</description>
          <population>According to Protocol (ATP) cohort for immunogenicity: included all eligible subjects with pre and post-vaccination serology results available for at least one vaccine components of measles, mumps or rubella, who did not meet any elimination criteria up to the Visit 2 blood sample and who complied with the post dose blood sample schedule.</population>
          <units>Percentage of subjects</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="1043"/>
                <count group_id="O2" value="521"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>≥ 150 mIU/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.3" lower_limit="98.6" upper_limit="99.7"/>
                    <measurement group_id="O2" value="96.7" lower_limit="94.8" upper_limit="98.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 200 mIU/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.0" lower_limit="98.2" upper_limit="99.5"/>
                    <measurement group_id="O2" value="96.5" lower_limit="94.6" upper_limit="97.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anti-measles Virus Antibody Concentrations</title>
        <description>Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. Analyses included initially seronegative subjects only.</description>
        <time_frame>At Day 42 post vaccination</time_frame>
        <population>ATP cohort for immunogenicity: included all eligible subjects with pre and post-vaccination serology results available for at least one vaccine components of measles, mumps or rubella, who did not meet any elimination criteria up to the Visit 2 blood sample and who complied with the post dose blood sample schedule.</population>
        <group_list>
          <group group_id="O1">
            <title>INV_MMR Group</title>
            <description>Subjects received 1 dose of the study vaccine Priorix co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.</description>
          </group>
          <group group_id="O2">
            <title>COM_MMR Group</title>
            <description>Subjects received 1 dose of the licensed vaccine M-M-R II or M-M-R VaxPro Lot 1 or Lot 2 co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Anti-measles Virus Antibody Concentrations</title>
          <description>Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. Analyses included initially seronegative subjects only.</description>
          <population>ATP cohort for immunogenicity: included all eligible subjects with pre and post-vaccination serology results available for at least one vaccine components of measles, mumps or rubella, who did not meet any elimination criteria up to the Visit 2 blood sample and who complied with the post dose blood sample schedule.</population>
          <units>mIU/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="1043"/>
                <count group_id="O2" value="521"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2751.9" lower_limit="2618.3" upper_limit="2892.2"/>
                    <measurement group_id="O2" value="3133.3" lower_limit="2878.6" upper_limit="3410.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value</title>
        <description>Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 10 ELISA Unit per milliliter [EU/mL] (ELISA, Pharmaceutical Product Development, Inc.[PPD]) among subjects who were seronegative (antibody concentration &lt; 5 EU/mL) before vaccination.</description>
        <time_frame>At Day 42 post vaccination</time_frame>
        <population>ATP cohort for immunogenicity: included all eligible subjects with pre and post-vaccination serology results available for at least one vaccine components of measles, mumps or rubella, who did not meet any elimination criteria up to the Visit 2 blood sample and who complied with the post dose blood sample schedule.</population>
        <group_list>
          <group group_id="O1">
            <title>INV_MMR Group</title>
            <description>Subjects received 1 dose of the study vaccine Priorix co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.</description>
          </group>
          <group group_id="O2">
            <title>COM_MMR Group</title>
            <description>Subjects received 1 dose of the licensed vaccine M-M-R II or M-M-R VaxPro Lot 1 or Lot 2 co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value</title>
          <description>Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 10 ELISA Unit per milliliter [EU/mL] (ELISA, Pharmaceutical Product Development, Inc.[PPD]) among subjects who were seronegative (antibody concentration &lt; 5 EU/mL) before vaccination.</description>
          <population>ATP cohort for immunogenicity: included all eligible subjects with pre and post-vaccination serology results available for at least one vaccine components of measles, mumps or rubella, who did not meet any elimination criteria up to the Visit 2 blood sample and who complied with the post dose blood sample schedule.</population>
          <units>Percentage of subjects</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="964"/>
                <count group_id="O2" value="483"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>≥ 5 EU/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.8" lower_limit="99.3" upper_limit="100"/>
                    <measurement group_id="O2" value="99.4" lower_limit="98.2" upper_limit="99.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 10 EU/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.4" lower_limit="98.7" upper_limit="99.8"/>
                    <measurement group_id="O2" value="97.9" lower_limit="96.2" upper_limit="99.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anti-mumps Virus Antibody Concentrations</title>
        <description>Antibody concentrations were expressed as GMCs in EU/mL. Analyses included initially seronegative subjects only.</description>
        <time_frame>At Day 42 post vaccination</time_frame>
        <population>According to Protocol (ATP) cohort for immunogenicity: included all eligible subjects with pre and post-vaccination serology results available for at least one vaccine components of measles, mumps, or rubella, who did not meet any elimination criteria up to the Visit 2 blood sample and who complied with the post dose blood sample schedule.</population>
        <group_list>
          <group group_id="O1">
            <title>INV_MMR Group</title>
            <description>Subjects received 1 dose of the study vaccine Priorix co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.</description>
          </group>
          <group group_id="O2">
            <title>COM_MMR Group</title>
            <description>Subjects received 1 dose of the licensed vaccine M-M-R II or M-M-R VaxPro Lot 1 or Lot 2 co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Anti-mumps Virus Antibody Concentrations</title>
          <description>Antibody concentrations were expressed as GMCs in EU/mL. Analyses included initially seronegative subjects only.</description>
          <population>According to Protocol (ATP) cohort for immunogenicity: included all eligible subjects with pre and post-vaccination serology results available for at least one vaccine components of measles, mumps, or rubella, who did not meet any elimination criteria up to the Visit 2 blood sample and who complied with the post dose blood sample schedule.</population>
          <units>EU/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="964"/>
                <count group_id="O2" value="483"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.0" lower_limit="82.0" upper_limit="90.3"/>
                    <measurement group_id="O2" value="82.6" lower_limit="76.5" upper_limit="89.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value</title>
        <description>Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥ 10 International Unit per milliliter [IU/mL] (ELISA, Enzygnost) among subjects who were seronegative (antibody concentration &lt; 4 IU/mL) before vaccination.</description>
        <time_frame>At Day 42 post vaccination</time_frame>
        <population>ATP cohort for immunogenicity: included all eligible subjects with pre and post-vaccination serology results available for at least one vaccine components of measles, mumps or rubella, who did not meet any elimination criteria up to the Visit 2 blood sample and who complied with the post dose blood sample schedule.</population>
        <group_list>
          <group group_id="O1">
            <title>INV_MMR Group</title>
            <description>Subjects received 1 dose of the study vaccine Priorix co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.</description>
          </group>
          <group group_id="O2">
            <title>COM_MMR Group</title>
            <description>Subjects received 1 dose of the licensed vaccine M-M-R II or M-M-R VaxPro Lot 1 or Lot 2 co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value</title>
          <description>Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥ 10 International Unit per milliliter [IU/mL] (ELISA, Enzygnost) among subjects who were seronegative (antibody concentration &lt; 4 IU/mL) before vaccination.</description>
          <population>ATP cohort for immunogenicity: included all eligible subjects with pre and post-vaccination serology results available for at least one vaccine components of measles, mumps or rubella, who did not meet any elimination criteria up to the Visit 2 blood sample and who complied with the post dose blood sample schedule.</population>
          <units>Percentage of subjects</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="1043"/>
                <count group_id="O2" value="521"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>≥4 IU/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.6" lower_limit="99.0" upper_limit="99.9"/>
                    <measurement group_id="O2" value="99.8" lower_limit="98.9" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥10 IU/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.7" lower_limit="94.3" upper_limit="96.8"/>
                    <measurement group_id="O2" value="98.3" lower_limit="96.7" upper_limit="99.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anti-rubella Virus Antibody Concentrations</title>
        <description>Antibody concentrations were expressed as GMCs in IU/mL. Analyses included initially seronegative subjects only.</description>
        <time_frame>At Day 42 post vaccination</time_frame>
        <population>ATP cohort for immunogenicity: included all eligible subjects with pre and post-vaccination serology results available for at least one vaccine components of measles, mumps or rubella, who did not meet any elimination criteria up to the Visit 2 blood sample and who complied with the post dose blood sample schedule.</population>
        <group_list>
          <group group_id="O1">
            <title>INV_MMR Group</title>
            <description>Subjects received 1 dose of the study vaccine Priorix co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.</description>
          </group>
          <group group_id="O2">
            <title>COM_MMR Group</title>
            <description>Subjects received 1 dose of the licensed vaccine M-M-R II or M-M-R VaxPro Lot 1 or Lot 2 co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Anti-rubella Virus Antibody Concentrations</title>
          <description>Antibody concentrations were expressed as GMCs in IU/mL. Analyses included initially seronegative subjects only.</description>
          <population>ATP cohort for immunogenicity: included all eligible subjects with pre and post-vaccination serology results available for at least one vaccine components of measles, mumps or rubella, who did not meet any elimination criteria up to the Visit 2 blood sample and who complied with the post dose blood sample schedule.</population>
          <units>IU/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="1043"/>
                <count group_id="O2" value="521"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.0" lower_limit="42.8" upper_limit="47.2"/>
                    <measurement group_id="O2" value="66.8" lower_limit="62.3" upper_limit="71.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Any Solicited Local Adverse Events (AEs)</title>
        <description>Assessed solicited local AEs were injection site pain, redness and swelling. Any = Occurrence of AE regardless of intensity grade or relation to vaccination.</description>
        <time_frame>During the 4-day (Days 0-3) post-vaccination period</time_frame>
        <population>Analysis was performed on TVC which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented.</population>
        <group_list>
          <group group_id="O1">
            <title>INV_MMR Group</title>
            <description>Subjects received 1 dose of the study vaccine Priorix co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.</description>
          </group>
          <group group_id="O2">
            <title>COM_MMR Group</title>
            <description>Subjects received 1 dose of the licensed vaccine M-M-R II or M-M-R VaxPro Lot 1 or Lot 2 co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Any Solicited Local Adverse Events (AEs)</title>
          <description>Assessed solicited local AEs were injection site pain, redness and swelling. Any = Occurrence of AE regardless of intensity grade or relation to vaccination.</description>
          <population>Analysis was performed on TVC which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1123"/>
                <count group_id="O2" value="553"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="312"/>
                    <measurement group_id="O2" value="131"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any redness (mm)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="260"/>
                    <measurement group_id="O2" value="137"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any swelling (mm)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96"/>
                    <measurement group_id="O2" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Any Solicited General AEs</title>
        <description>Assessed solicited general AEs were drowsiness, irritability/fussiness and loss of appetite. Any = Occurrence of AE regardless of intensity grade or relation to vaccination.</description>
        <time_frame>During the 15-day (Days 0-14) post-vaccination period</time_frame>
        <population>Analysis was performed on TVC which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented.</population>
        <group_list>
          <group group_id="O1">
            <title>INV_MMR Group</title>
            <description>Subjects received 1 dose of the study vaccine Priorix co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.</description>
          </group>
          <group group_id="O2">
            <title>COM_MMR Group</title>
            <description>Subjects received 1 dose of the licensed vaccine M-M-R II or M-M-R VaxPro Lot 1 or Lot 2 co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Any Solicited General AEs</title>
          <description>Assessed solicited general AEs were drowsiness, irritability/fussiness and loss of appetite. Any = Occurrence of AE regardless of intensity grade or relation to vaccination.</description>
          <population>Analysis was performed on TVC which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1126"/>
                <count group_id="O2" value="555"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any drowsiness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="527"/>
                    <measurement group_id="O2" value="238"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any irritability/fussiness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="722"/>
                    <measurement group_id="O2" value="345"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any loss of appetite</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="493"/>
                    <measurement group_id="O2" value="232"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting Any Fever</title>
        <description>Any fever (≥ 38°C) = Occurrence of fever regardless of intensity grade or relation to vaccination.</description>
        <time_frame>During the 43-day (Days 0-42) post-vaccination period</time_frame>
        <population>Analysis was performed on TVC which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented.</population>
        <group_list>
          <group group_id="O1">
            <title>INV_MMR Group</title>
            <description>Subjects received 1 dose of the study vaccine Priorix co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.</description>
          </group>
          <group group_id="O2">
            <title>COM_MMR Group</title>
            <description>Subjects received 1 dose of the licensed vaccine M-M-R II or M-M-R VaxPro Lot 1 or Lot 2 co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Any Fever</title>
          <description>Any fever (≥ 38°C) = Occurrence of fever regardless of intensity grade or relation to vaccination.</description>
          <population>Analysis was performed on TVC which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1126"/>
                <count group_id="O2" value="555"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="350"/>
                    <measurement group_id="O2" value="179"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting Any Rash</title>
        <description>Any rash = Occurrence of AE regardless of intensity grade or relation to vaccination.</description>
        <time_frame>During the 43-day (Days 0-42) post-vaccination period</time_frame>
        <population>Analysis was performed on TVC which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented.</population>
        <group_list>
          <group group_id="O1">
            <title>INV_MMR Group</title>
            <description>Subjects received 1 dose of the study vaccine Priorix co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.</description>
          </group>
          <group group_id="O2">
            <title>COM_MMR Group</title>
            <description>Subjects received 1 dose of the licensed vaccine M-M-R II or M-M-R VaxPro Lot 1 or Lot 2 co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Any Rash</title>
          <description>Any rash = Occurrence of AE regardless of intensity grade or relation to vaccination.</description>
          <population>Analysis was performed on TVC which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1126"/>
                <count group_id="O2" value="555"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any localized or generalized</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="275"/>
                    <measurement group_id="O2" value="152"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any with fever</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any varicella like</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any measles/rubella like</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting MMR Specific Solicited General AEs</title>
        <description>Assessed MMR specific solicited general AEs were parotid gland swelling and any suspected signs of meningism including febrile convulsions. Any = Occurrence of AE regardless of intensity grade or relation to vaccination.</description>
        <time_frame>During the 43-day (Days 0-42) post-vaccination period</time_frame>
        <population>Analysis was performed on TVC which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented.</population>
        <group_list>
          <group group_id="O1">
            <title>INV_MMR Group</title>
            <description>Subjects received 1 dose of the study vaccine Priorix co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.</description>
          </group>
          <group group_id="O2">
            <title>COM_MMR Group</title>
            <description>Subjects received 1 dose of the licensed vaccine M-M-R II or M-M-R VaxPro Lot 1 or Lot 2 co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting MMR Specific Solicited General AEs</title>
          <description>Assessed MMR specific solicited general AEs were parotid gland swelling and any suspected signs of meningism including febrile convulsions. Any = Occurrence of AE regardless of intensity grade or relation to vaccination.</description>
          <population>Analysis was performed on TVC which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1126"/>
                <count group_id="O2" value="555"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any parotid gland swelling</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any febrile convulsion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting Any Unsolicited AEs</title>
        <description>Unsolicited AE included any AE reported in addition to those solicited during the clinical study and any 'solicited' AE with onset outside the specified period of follow-up for solicited AEs. Any = Occurrence of AE regardless of intensity grade or relation to vaccination.</description>
        <time_frame>During the 43-day (Days 0-42) post-vaccination period</time_frame>
        <population>Analysis was performed on TVC which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented.</population>
        <group_list>
          <group group_id="O1">
            <title>INV_MMR Group</title>
            <description>Subjects received 1 dose of the study vaccine Priorix co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.</description>
          </group>
          <group group_id="O2">
            <title>COM_MMR Group</title>
            <description>Subjects received 1 dose of the licensed vaccine M-M-R II or M-M-R VaxPro Lot 1 or Lot 2 co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Any Unsolicited AEs</title>
          <description>Unsolicited AE included any AE reported in addition to those solicited during the clinical study and any 'solicited' AE with onset outside the specified period of follow-up for solicited AEs. Any = Occurrence of AE regardless of intensity grade or relation to vaccination.</description>
          <population>Analysis was performed on TVC which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1164"/>
                <count group_id="O2" value="572"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="598"/>
                    <measurement group_id="O2" value="277"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting AEs of Specific Interest</title>
        <description>AEs of specific interest included new onset chronic disease (NOCD) (e.g., autoimmune disorders, asthma, type I diabetes, vasculitis, celiac disease, conditions associated with sub-acute or chronic thrombocytopenia and allergies) and AEs prompting emergency room (ER) visits.</description>
        <time_frame>Day 0 through the end of the study (Day 180)</time_frame>
        <population>Analysis was performed on TVC which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented.</population>
        <group_list>
          <group group_id="O1">
            <title>INV_MMR Group</title>
            <description>Subjects received 1 dose of the study vaccine Priorix co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.</description>
          </group>
          <group group_id="O2">
            <title>COM_MMR Group</title>
            <description>Subjects received 1 dose of the licensed vaccine M-M-R II or M-M-R VaxPro Lot 1 or Lot 2 co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting AEs of Specific Interest</title>
          <description>AEs of specific interest included new onset chronic disease (NOCD) (e.g., autoimmune disorders, asthma, type I diabetes, vasculitis, celiac disease, conditions associated with sub-acute or chronic thrombocytopenia and allergies) and AEs prompting emergency room (ER) visits.</description>
          <population>Analysis was performed on TVC which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1164"/>
                <count group_id="O2" value="572"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>NOCDs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AEs prompting ER visits</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="166"/>
                    <measurement group_id="O2" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting Any Serious Adverse Events (SAEs)</title>
        <description>SAE included any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization or resulted in disability/incapacity. Any = Occurrence of AE regardless of intensity grade or relation to vaccination.</description>
        <time_frame>Day 0 through the end of the study (Day 180)</time_frame>
        <population>Analysis was performed on TVC which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented.</population>
        <group_list>
          <group group_id="O1">
            <title>INV_MMR</title>
            <description>Subjects received 1 dose of the study vaccine Priorix co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.</description>
          </group>
          <group group_id="O2">
            <title>COM_MMR</title>
            <description>Subjects received 1 dose of the licensed vaccine M-M-R II or M-M-R VaxPro Lot 1 or Lot 2 co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Any Serious Adverse Events (SAEs)</title>
          <description>SAE included any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization or resulted in disability/incapacity. Any = Occurrence of AE regardless of intensity grade or relation to vaccination.</description>
          <population>Analysis was performed on TVC which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1164"/>
                <count group_id="O2" value="572"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting Measles-like Illness</title>
        <description>Measles-like illness was defined as the occurrence of the following signs/symptoms in the absence of another confirmed diagnosis:&#xD;
maculopapular rash (includes measles/rubella-like rash), fever (≥ 38°C) and at least one of the symptoms: cough, coryza (runny nose), conjunctivitis or diarrhea, with fever or rash. Other event must be one of cough, coryza, conjunctivitis, or diarrhea.</description>
        <time_frame>During Day 5 to Day 12 post-vaccination period</time_frame>
        <population>Analysis was performed on TVC which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented.</population>
        <group_list>
          <group group_id="O1">
            <title>INV_MMR Group</title>
            <description>Subjects received 1 dose of the study vaccine Priorix co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.</description>
          </group>
          <group group_id="O2">
            <title>COM_MMR Group</title>
            <description>Subjects received 1 dose of the licensed vaccine M-M-R II or M-M-R VaxPro Lot 1 or Lot 2 co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Measles-like Illness</title>
          <description>Measles-like illness was defined as the occurrence of the following signs/symptoms in the absence of another confirmed diagnosis:&#xD;
maculopapular rash (includes measles/rubella-like rash), fever (≥ 38°C) and at least one of the symptoms: cough, coryza (runny nose), conjunctivitis or diarrhea, with fever or rash. Other event must be one of cough, coryza, conjunctivitis, or diarrhea.</description>
          <population>Analysis was performed on TVC which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1164"/>
                <count group_id="O2" value="572"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Measles-like illness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maculopapular rash plus fever and one other event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maculopapular rash and fever</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90"/>
                    <measurement group_id="O2" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>SAEs = From Day 0 to study end (Day 180); Solicited local and general AEs = During the 4-day (Day 0-3) and 15-day (Day 0-14) post vaccination period, respectively; Unsolicited adverse events = During the 43-day (Day 0-42) post vaccination period.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>INV_MMR Group</title>
          <description>Subjects received 1 dose of the study vaccine Priorix co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.</description>
        </group>
        <group group_id="E2">
          <title>COM_MMR Group</title>
          <description>Subjects received 1 dose of the licensed vaccine M-M-R II or M-M-R VaxPro Lot 1 or Lot 2 co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also received Prevnar 13 at Day 0.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 19.0</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="0" subjects_at_risk="1164"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="572"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="1164"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="572"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Immune thrombocytopenic purpura</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="572"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="572"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="572"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Acute sinusitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="572"/>
              </event>
              <event>
                <sub_title>Bacterial infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="572"/>
              </event>
              <event>
                <sub_title>Bronchiolitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="572"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="1164"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="572"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="572"/>
              </event>
              <event>
                <sub_title>Croup infectious</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="572"/>
              </event>
              <event>
                <sub_title>Exanthema subitum</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="572"/>
              </event>
              <event>
                <sub_title>Fungal skin infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="572"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="572"/>
              </event>
              <event>
                <sub_title>Gastroenteritis norovirus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="572"/>
              </event>
              <event>
                <sub_title>Gastroenteritis salmonella</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="572"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="572"/>
              </event>
              <event>
                <sub_title>Hand-foot-and-mouth disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="572"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="572"/>
              </event>
              <event>
                <sub_title>Laryngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="572"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="572"/>
              </event>
              <event>
                <sub_title>Parainfluenzae virus infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="572"/>
              </event>
              <event>
                <sub_title>Periorbital cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="572"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="1164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="572"/>
              </event>
              <event>
                <sub_title>Pneumonia respiratory syncytial viral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="572"/>
              </event>
              <event>
                <sub_title>Respiratory syncytial virus infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="572"/>
              </event>
              <event>
                <sub_title>Salmonellosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="572"/>
              </event>
              <event>
                <sub_title>Staphylococcal infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="572"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="572"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="572"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="572"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="1164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="572"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="572"/>
              </event>
              <event>
                <sub_title>Hypovolaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="572"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Joint effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="572"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Febrile convulsion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="572"/>
              </event>
              <event>
                <sub_title>Lethargy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="572"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="572"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Bronchial hyperreactivity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="572"/>
              </event>
              <event>
                <sub_title>Obstructive airways disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1164"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="572"/>
              </event>
              <event>
                <sub_title>Respiratory distress</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1164"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="572"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 19.0</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="980" subjects_at_risk="1164"/>
                <counts group_id="E2" subjects_affected="477" subjects_at_risk="572"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="105" subjects_affected="95" subjects_at_risk="1164"/>
                <counts group_id="E2" events="53" subjects_affected="46" subjects_at_risk="572"/>
              </event>
              <event>
                <sub_title>Teething</sub_title>
                <counts group_id="E1" events="71" subjects_affected="59" subjects_at_risk="1164"/>
                <counts group_id="E2" events="17" subjects_affected="15" subjects_at_risk="572"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" events="297" subjects_affected="284" subjects_at_risk="1164"/>
                <counts group_id="E2" events="149" subjects_affected="143" subjects_at_risk="572"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" events="314" subjects_affected="313" subjects_at_risk="1164"/>
                <counts group_id="E2" events="133" subjects_affected="133" subjects_at_risk="572"/>
              </event>
              <event>
                <sub_title>Injection site swelling</sub_title>
                <counts group_id="E1" events="108" subjects_affected="105" subjects_at_risk="1164"/>
                <counts group_id="E2" events="62" subjects_affected="61" subjects_at_risk="572"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="350" subjects_affected="350" subjects_at_risk="1164"/>
                <counts group_id="E2" events="180" subjects_affected="180" subjects_at_risk="572"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" events="95" subjects_affected="86" subjects_at_risk="1164"/>
                <counts group_id="E2" events="36" subjects_affected="35" subjects_at_risk="572"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="119" subjects_affected="111" subjects_at_risk="1164"/>
                <counts group_id="E2" events="75" subjects_affected="73" subjects_at_risk="572"/>
              </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="497" subjects_affected="495" subjects_at_risk="1164"/>
                <counts group_id="E2" events="234" subjects_affected="233" subjects_at_risk="572"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="529" subjects_affected="529" subjects_at_risk="1164"/>
                <counts group_id="E2" events="238" subjects_affected="238" subjects_at_risk="572"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" events="740" subjects_affected="723" subjects_at_risk="1164"/>
                <counts group_id="E2" events="350" subjects_affected="348" subjects_at_risk="572"/>
              </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="85" subjects_affected="80" subjects_at_risk="1164"/>
                <counts group_id="E2" events="31" subjects_affected="30" subjects_at_risk="572"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="275" subjects_affected="275" subjects_at_risk="1164"/>
                <counts group_id="E2" events="152" subjects_affected="152" subjects_at_risk="572"/>
              </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>GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>GSK Response Center</name_or_title>
      <organization>GlaxoSmithKline</organization>
      <phone>866-435-7343</phone>
    </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/NCT02184572
org study id: 115650
secondary id: 2011-006161-18
nct id: NCT02184572
lead sponsor: 
The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals'
      trivalent MMR (Priorix), comparing it to Merck's MMR vaccine (M-M-R II), which is approved
      for use in the US in healthy children 12 to 15 months of age.
This study will evaluate the safety of GSK's trivalent MMR vaccine (referred to as INV_MMR
      vaccine) at a potency that will be used to define maximum release limits for the INV_MMR in
      comparison to the US standard of care (M-M-R II/ M-M-R VaxPro vaccine referred to as COM_MMR
      vaccine). In order to obtain more representative data on the comparator vaccine, the COM_MMR
      used in this study will consist of two lots designated COM_MMR_L1 and COM_MMR_L2. Throughout
      the study COM_MMR_L1 and COM_MMR_L2 will be analyzed as pooled lots. This study is intended
      to support licensure of GSK's MMR vaccine in the US.

      All children will receive Varivax and Havrix vaccines, concomitantly with MMR containing
      vaccine at 12 to 15 months of age. Prevnar 13 will be administered only to US children. At
      the end of the study, GSK will provide a second dose of Havrix and/or varicella vaccine to
      participants enrolled in selected non-US countries if local health departments do not
      routinely provide hepatitis A and varicella vaccination. The second dose of Havrix and
      varicella vaccine is not part of the study procedures.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of Subjects Reporting Fever After MMR (Priorix or M-M-R II/M-M-R VaxPro [Lot 1 or Lot 2]) Vaccination
time frame: During Day 5 to Day 12 post-vaccination period
description: Fever was assessed for temperature equal to/above (≥) 38.0°C and above (>) 39.0°C. The safety profile for fever was assessed based on the group difference (INV_MMR minus COM_MMR) in incidence of fever equal to or below the cut-off value.
measure: Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value
time frame: At Day 42 post vaccination
description: Seroresponse was defined as post-vaccination anti-measles virus antibody concentration greater than or equal to [≥] 200 milli International Units per milliliter [mIU/mL] (Enzyme-Linked Immunosorbent Assay [ELISA], Enzygnost) among subjects who were seronegative (antibody concentration less than [<] 150 mIU/mL) before vaccination.
measure: Anti-measles Virus Antibody Concentrations
time frame: At Day 42 post vaccination
description: Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. Analyses included initially seronegative subjects only.
measure: Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value
time frame: At Day 42 post vaccination
description: Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 10 ELISA Unit per milliliter [EU/mL] (ELISA, Pharmaceutical Product Development, Inc.[PPD]) among subjects who were seronegative (antibody concentration < 5 EU/mL) before vaccination.
measure: Anti-mumps Virus Antibody Concentrations
time frame: At Day 42 post vaccination
description: Antibody concentrations were expressed as GMCs in EU/mL. Analyses included initially seronegative subjects only.
measure: Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value
time frame: At Day 42 post vaccination
description: Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥ 10 International Unit per milliliter [IU/mL] (ELISA, Enzygnost) among subjects who were seronegative (antibody concentration < 4 IU/mL) before vaccination.
measure: Anti-rubella Virus Antibody Concentrations
time frame: At Day 42 post vaccination
description: Antibody concentrations were expressed as GMCs in IU/mL. Analyses included initially seronegative subjects only.
measure: Number of Subjects With Any Solicited Local Adverse Events (AEs)
time frame: During the 4-day (Days 0-3) post-vaccination period
description: Assessed solicited local AEs were injection site pain, redness and swelling. Any = Occurrence of AE regardless of intensity grade or relation to vaccination.
measure: Number of Subjects With Any Solicited General AEs
time frame: During the 15-day (Days 0-14) post-vaccination period
description: Assessed solicited general AEs were drowsiness, irritability/fussiness and loss of appetite. Any = Occurrence of AE regardless of intensity grade or relation to vaccination.
measure: Number of Subjects Reporting Any Fever
time frame: During the 43-day (Days 0-42) post-vaccination period
description: Any fever (≥ 38°C) = Occurrence of fever regardless of intensity grade or relation to vaccination.
measure: Number of Subjects Reporting Any Rash
time frame: During the 43-day (Days 0-42) post-vaccination period
description: Any rash = Occurrence of AE regardless of intensity grade or relation to vaccination.
measure: Number of Subjects Reporting MMR Specific Solicited General AEs
time frame: During the 43-day (Days 0-42) post-vaccination period
description: Assessed MMR specific solicited general AEs were parotid gland swelling and any suspected signs of meningism including febrile convulsions. Any = Occurrence of AE regardless of intensity grade or relation to vaccination.
measure: Number of Subjects Reporting Any Unsolicited AEs
time frame: During the 43-day (Days 0-42) post-vaccination period
description: Unsolicited AE included any AE reported in addition to those solicited during the clinical study and any 'solicited' AE with onset outside the specified period of follow-up for solicited AEs. Any = Occurrence of AE regardless of intensity grade or relation to vaccination.
measure: Number of Subjects Reporting AEs of Specific Interest
time frame: Day 0 through the end of the study (Day 180)
description: AEs of specific interest included new onset chronic disease (NOCD) (e.g., autoimmune disorders, asthma, type I diabetes, vasculitis, celiac disease, conditions associated with sub-acute or chronic thrombocytopenia and allergies) and AEs prompting emergency room (ER) visits.
measure: Number of Subjects Reporting Any Serious Adverse Events (SAEs)
time frame: Day 0 through the end of the study (Day 180)
description: SAE included any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization or resulted in disability/incapacity. Any = Occurrence of AE regardless of intensity grade or relation to vaccination.
measure: Number of Subjects Reporting Measles-like Illness
time frame: During Day 5 to Day 12 post-vaccination period
description: Measles-like illness was defined as the occurrence of the following signs/symptoms in the absence of another confirmed diagnosis:
maculopapular rash (includes measles/rubella-like rash), fever (≥ 38°C) and at least one of the symptoms: cough, coryza (runny nose), conjunctivitis or diarrhea, with fever or rash. Other event must be one of cough, coryza, conjunctivitis, or diarrhea.
arm group label: INV_MMR
arm group type: Experimental
description: Subjects receive 1 dose of the study vaccine Priorix co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also receive Prevnar 13 at Day 0.
arm group label: COM_MMR
arm group type: Active Comparator
description: Subjects receive 1 dose of the licensed vaccine M-M-R II or M-M-R VaxPro Lot 1 or Lot 2 co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also receive Prevnar 13 at Day 0.
intervention type: Biological
intervention name: Priorix
description: 1 dose administered subcutaneously in the triceps region of left arm at Day 0
arm group label: INV_MMR
other name: GSK Biologicals' live attenuated measles
other name: mumps and rubella (MMR) vaccine
intervention type: Biological
intervention name: M-M-R II
description: 1 dose administered subcutaneously in the triceps region of left arm at Day 0
arm group label: COM_MMR
other name: MMR vaccine live (M-M R II
other name: Merck & Co.
other name: Inc.
other name: or M-M-R VaxPro
other name: Sanofi Pasteur/Merck Sharp and Dohme [SPMSD])
intervention type: Biological
intervention name: Varivax
description: 1 dose administered subcutaneously in the triceps region of right arm at Day 0
arm group label: COM_MMR
arm group label: INV_MMR
other name: Merck & Co. Inc.'s Varicella virus vaccine
other name: live
intervention type: Biological
intervention name: Havrix
description: 1 dose administered intramuscularly in the anterolateral region of the right thigh at Day 0
arm group label: COM_MMR
arm group label: INV_MMR
other name: GSK Biologicals' Hepatitis A vaccine
other name: inactivated
intervention type: Biological
intervention name: Prevnar 13
description: 1 dose administered intramuscularly in the anterolateral region of the left thigh at Day 0 to subjects recruited in US
arm group label: COM_MMR
arm group label: INV_MMR
other name: Pfizer Inc.'s Pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein)
criteria: 
gender: All
minimum age: 12 Months
maximum age: 15 Months
healthy volunteers: Accepts Healthy Volunteers
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
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country: Estonia
country: Finland
country: Puerto Rico
country: Taiwan
country: United States
citation: MMR-162 Study Group. Safety and immunogenicity of an upper-range release titer measles-mumps-rubella vaccine in children vaccinated at 12 to 15 months of age: a phase III, randomized study. Hum Vaccin Immunother. 2018;14(12):2921-2931. doi: 10.1080/21645515.2018.1502527. Epub 2018 Aug 29.
PMID: 30118386
responsible party type: Sponsor
mesh term: Measles
mesh term: Rubella
mesh term: Mumps
mesh term: Vaccines
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