<clinical_study>
  <!-- This xml conforms to an XML Schema at:
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  <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/NCT01681992</url>
  </required_header>
  <id_info>
    <org_study_id>115649</org_study_id>
    <secondary_id>2011-004905-26</secondary_id>
    <nct_id>NCT01681992</nct_id>
  </id_info>
  <brief_title>Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Children in Their Second Year of Life</brief_title>
  <official_title>Immunogenicity and Safety Study of GSK Biologicals' Priorix Vaccine (209762) at an End of Shelf-life Potency Compared to Merck &amp; Co., Inc.'s Measles-mumps-rubella (MMR) Vaccine When Both Are Given on a 2-dose Schedule to Healthy Children in Their 2nd Year of Life</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 end of shelf-life potency in terms of the&#xD;
      immunogenicity and safety of GSK Biologicals' trivalent MMR vaccine, by comparing it to Merck&#xD;
      &amp; Co., Inc.'s MMR vaccine, which is approved for use in the United States (US).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This trial is a Phase IIIA, randomized, observer-blind, controlled, multi-center,&#xD;
      multi-country study with four parallel groups. This study will evaluate the immunogenicity&#xD;
      and safety of GSK Biologicals' trivalent investigational MMR vaccine (referred to as Inv_MMR&#xD;
      vaccine, throughout this document) in contrast to the US standard of care comparator vaccine&#xD;
      (M-M-R II, Merck and Co., Inc., referred to as Com_MMR throughout this document) in children&#xD;
      during their second year of life. The first dose of this two-dose study is designed to&#xD;
      establish the end of shelf-life potency of Inv_MMR vaccine. The Inv_MMR vaccine will be given&#xD;
      as one of two lots; one of a minimum potency, designated Inv_MMR_Min; and the other at a&#xD;
      mid-range or medium potency designated Inv_MMR_Med to two groups. The second dose for both of&#xD;
      these Inv_MMR groups will have a potency within the release range of the marketed vaccine.&#xD;
      The Com_MMR vaccine will consist of two lots designated Com_MMR_L1 and Com_MMR_L2 and will be&#xD;
      analyzed as pooled lots within the study. The first MMR vaccine dose will be co-administered&#xD;
      with Varivax, Havrix and (in the US sub-cohort only) Prevnar 13 which are routinely&#xD;
      administered to children of this age in the US.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 10, 2012</start_date>
  <completion_date type="Actual">August 18, 2015</completion_date>
  <primary_completion_date type="Actual">February 3, 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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value (by Enzyme-linked Immunosorbent Assay [ELISA])</measure>
    <time_frame>At Day 42</time_frame>
    <description>For measles virus, a seroresponse was defined as post-vaccination anti-measles virus antibody concentration equal or above [≥] 200 mIU/mL (ELISA) among subjects who were seronegative (antibody concentration less than [&lt;] 150 mIU/mL) before dose 1. Criteria to demonstrate an acceptable immune response of Inv_MMR_Min/Inv_MMR_Med vaccine in terms of seroresponse rate for measles virus at Day 42: The lower limit of the two-sided 97.5% CI for the seroresponse rate of Inv_MMR_Min/Inv_MMR_Med was to be ≥ 90% for antibodies to measles virus.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA)</measure>
    <time_frame>At Day 42</time_frame>
    <description>For mumps virus, a seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 10 EU/mL (ELISA) among subjects who were seronegative (antibody concentration &lt; 5 EU/mL) before dose 1. Criteria to demonstrate an acceptable immune response of Inv_MMR_Min/Inv_MMR_Med vaccine in terms of seroresponse rate for mumps virus at Day 42: The lower limit of the two-sided 97.5% CI for the seroresponse rate of Inv_MMR_Min/Inv_MMR_Med was to be ≥ 90% for antibodies to mumps virus.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value (by Plaque Reduction Neutralization Test [PRNT])</measure>
    <time_frame>At Day 42</time_frame>
    <description>For mumps virus as measured by PRNT, a seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 4 End point Dilution 50% (ED50) (PRNT) among subjects who were seronegative (antibody concentration &lt; 2.5 ED50) before dose 1.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA)</measure>
    <time_frame>At Day 42</time_frame>
    <description>For rubella virus, a seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥ 10 IU/mL (ELISA) among subjects who were seronegative (antibody concentration &lt; 4 IU/mL) before dose 1. Criteria to demonstrate an acceptable immune response of Inv_MMR_Min/Inv_MMR_Med vaccine in terms of seroresponse rate for rubella virus at Day 42: The lower limit of the two-sided 97.5% CI for the seroresponse rate of Inv_MMR_Min/Inv_MMR_Med was to be ≥ 90% for antibodies to mumps virus.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anti-measles Virus Antibody Concentrations (by ELISA)</measure>
    <time_frame>At Day 42</time_frame>
    <description>Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anti-mumps Virus Antibody Concentrations (by ELISA)</measure>
    <time_frame>At Day 42</time_frame>
    <description>Antibody concentrations were expressed as GMCs in EU/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anti-mumps Virus Antibody Concentrations (by PRNT)</measure>
    <time_frame>At Day 42</time_frame>
    <description>Antibody concentrations were expressed as Geometric Mean Titers (GMTs).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anti-rubella Virus Antibody Concentrations (by ELISA)</measure>
    <time_frame>At Day 42</time_frame>
    <description>Antibody concentrations were expressed as GMCs in IU/mL.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA)</measure>
    <time_frame>At Day 84</time_frame>
    <description>For measles virus, a seroresponse was defined as post-vaccination anti-measles virus antibody concentration ≥ 200 mIU/mL (ELISA) among subjects who were seronegative (antibody concentration &lt; 150 mIU/mL) before dose 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA)</measure>
    <time_frame>At Day 84</time_frame>
    <description>For mumps virus, a seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 10 EU/mL (ELISA) among subjects who were seronegative (antibody concentration &lt; 5 EU/mL) before dose 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA)</measure>
    <time_frame>At Day 84</time_frame>
    <description>For rubella virus, a seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥ 10 IU/mL (ELISA) among subjects who were seronegative (antibody concentration &lt; 4 IU/mL) before dose 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-measles Virus Antibody Concentrations (by ELISA)</measure>
    <time_frame>At Day 84</time_frame>
    <description>Antibody concentrations were expressed as GMCs in mIU/mL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-mumps Virus Antibody Concentrations (by ELISA)</measure>
    <time_frame>At Day 84</time_frame>
    <description>Antibody concentrations were expressed as GMCs in EU/mL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-rubella Virus Antibody Concentrations (by ELISA)</measure>
    <time_frame>At Day 84</time_frame>
    <description>Antibody concentrations were expressed as GMCs in IU/mL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Any Solicited Local Adverse Events (AEs) Post Dose 1</measure>
    <time_frame>During the 4-day (Days 0-3) post-vaccination period</time_frame>
    <description>Assessed solicited local AEs were pain, redness and swelling. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Any Solicited Local AEs Post Dose 2</measure>
    <time_frame>During the 4-day (Days 0-3) post-vaccination period</time_frame>
    <description>Assessed solicited local AEs were pain, redness and swelling. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Any Solicited General AEs Post Dose 1</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 the AE regardless of intensity grade or relation to vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Any Fever Post Dose 1</measure>
    <time_frame>During the 43-day (Days 0-42) post-vaccination period</time_frame>
    <description>Any fever = Fever (axillary) ≥ 38°C.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Any Fever Post Dose 2</measure>
    <time_frame>During the 43-day (Days 0-42) post-vaccination period</time_frame>
    <description>Any fever = Fever (axillary) ≥ 38°C.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Any Rash Post Dose 1</measure>
    <time_frame>During the 43-day (Days 0-42) post-vaccination period</time_frame>
    <description>Assessed were any localized or generalized rash, rash with fever, varicella-like rash and measles/rubella-like rash. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Any Rash Post Dose 2</measure>
    <time_frame>During the 43-day (Days 0-42) post-vaccination period</time_frame>
    <description>Assessed were any localized or generalized rash, rash with fever, varicella-like rash and measles/rubella-like rash. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Any MMR Specific Solicited General AEs Post Dose 1</measure>
    <time_frame>During the 43-day (Days 0-42) post-vaccination period</time_frame>
    <description>Assessed MMR specific solicited general AEs were any suspected signs of meningism including febrile convulsions and parotid/salivary gland swelling. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Any MMR Specific Solicited General AEs Post Dose 2</measure>
    <time_frame>During the 43-day (Days 0-42) post-vaccination period</time_frame>
    <description>Assessed MMR specific solicited general AEs were any suspected signs of meningism including febrile convulsions and parotid/salivary gland swelling. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Any Unsolicited AES Post Dose 1</measure>
    <time_frame>During the 43-day (Days 0-42) post-vaccination period</time_frame>
    <description>Unsolicited AE was defined as any AE reported in 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 the AE regardless of intensity grade or relation to vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Any Unsolicited AES Post Dose 2</measure>
    <time_frame>During the 43-day (Days 0-42) post-vaccination period</time_frame>
    <description>Unsolicited AE was defined as any AE reported in 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 the AE regardless of intensity grade or relation to vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Any AEs of Specific Interest</measure>
    <time_frame>From Day 0 through the end of the study (Day 222)</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>From Day 0 through the end of the study (Day 222)</time_frame>
    <description>SAEs assessed include any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization or resulted in disability/incapacity.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">4538</enrollment>
  <condition>Measles</condition>
  <condition>Mumps</condition>
  <condition>Rubella</condition>
  <condition>Measles-Mumps-Rubella Vaccine</condition>
  <arm_group>
    <arm_group_label>Inv_MMR_Min Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects receive one dose of GlaxoSmithKline (GSK) Biologicals' measles, mumps, rubella (MMR) vaccine, Priorix (Inv_MMR), from a minimum potency lot (Inv_MMR_Min), co-administered with Varivax (VV) and Havrix (HAV) vaccines at Day 0. All US subjects are also co-administered Prevnar 13 (PCV-13) vaccine. Approximately 6 weeks later, at Day 42, subjects are administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines are administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines are administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Inv_MMR_Med Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects receive one dose of GlaxoSmithKline (GSK) Biologicals' measles, mumps, rubella (MMR) vaccine, Priorix (Inv_MMR), from a mid-range or medium potency lot (Inv_MMR_Med), co-administered with Varivax (VV) and Havrix (HAV) vaccines at Day 0. All US subjects are also co-administered Prevnar 13 (PCV-13) vaccine. Approximately 6 weeks later, at Day 42, subjects are administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines are administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines are administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Com_MMR Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects receive one dose of M-M-R II (Com_MMR) vaccine (Lot 1 or Lot 2), co-administered with Varivax (VV) and Havrix (HAV) vaccines at Day 0. All US subjects are also co-administered Prevnar 13 (PCV-13) vaccine. Approximately 6 weeks later, at Day 42, subjects are administered a dose of Com_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com_MMR and VV vaccines are administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines are administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Priorix</intervention_name>
    <description>Subjects receive one dose of either minimum (Inv_MMR_Min) or medium (Inv_MMR_Med) potency lot at Day 0 and a dose of separate potency lot (Inv_MMR_Release) at Day 42, administered subcutaneously in the triceps region of the left arm.</description>
    <arm_group_label>Inv_MMR_Med Group</arm_group_label>
    <arm_group_label>Inv_MMR_Min Group</arm_group_label>
    <other_name>GSK Biologicals' live attenuated measles</other_name>
    <other_name>mumps</other_name>
    <other_name>rubella vaccine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>M-M-R II</intervention_name>
    <description>Subjects receive two doses of either Lot 1 or Lot 2, one at Day 0 and one at Day 42, administered subcutaneously in the triceps region of the left arm.</description>
    <arm_group_label>Com_MMR Group</arm_group_label>
    <other_name>Merck &amp; Co.</other_name>
    <other_name>Inc.'s measles</other_name>
    <other_name>mumps</other_name>
    <other_name>rubella virus vaccine</other_name>
    <other_name>live</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Varivax</intervention_name>
    <description>Subjects receive one dose co-administered subcutaneously with the study vaccines (Priorix and M-M-R II), in the triceps region of right arm, at Day 0.</description>
    <arm_group_label>Com_MMR Group</arm_group_label>
    <arm_group_label>Inv_MMR_Med Group</arm_group_label>
    <arm_group_label>Inv_MMR_Min Group</arm_group_label>
    <other_name>Merck &amp; Co.</other_name>
    <other_name>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>Subjects receive one dose co-administered intramuscularly with the study vaccines (Priorix and M-M-R II), in the anterolateral region of the right thigh, at Day 0.</description>
    <arm_group_label>Com_MMR Group</arm_group_label>
    <arm_group_label>Inv_MMR_Med Group</arm_group_label>
    <arm_group_label>Inv_MMR_Min Group</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>US Subjects receive one dose co-administered intramuscularly with the study vaccines (Priorix and M-M-R II), in the anterolateral region of the left thigh, at Day 0.</description>
    <arm_group_label>Com_MMR Group</arm_group_label>
    <arm_group_label>Inv_MMR_Med Group</arm_group_label>
    <arm_group_label>Inv_MMR_Min Group</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 at the time of vaccination.&#xD;
&#xD;
          -  The investigator believes that the parent(s) or Legally Acceptable Representative(s)&#xD;
             (LAR(s)) of the child, 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:&#xD;
&#xD;
        • Child that previously received a 3-dose series of Prevnar 13 with last dose at least 60&#xD;
        days prior to study entry.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Child in care.&#xD;
&#xD;
          -  Use of any investigational or non-registered product other than the study vaccine(s)&#xD;
             during the period starting 30 days before the day of study vaccination or planned use&#xD;
             during the entire study 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. Chronic&#xD;
             administration of immunosuppressants, or other immune-modifying drugs during the&#xD;
             period starting 180 days prior to the first vaccine dose or any planned administration&#xD;
             of immunosuppressive and immune-modifying drugs during the entire study.&#xD;
&#xD;
               -  Inhaled and topical steroids are allowed.&#xD;
&#xD;
          -  Planned administration / administration of a vaccine not foreseen by the study&#xD;
             protocol during the period starting 30 days prior to study vaccination at Visit 1 and&#xD;
             ending at Visit 2 (or ending at Visit 3 for the US post-dose 2 sub-cohort). Please&#xD;
             Note:&#xD;
&#xD;
               -  Inactivated influenza (Flu) vaccine and Haemophilus influenzae type b conjugate&#xD;
                  vaccine (Hib) vaccines may be given at any time during the study, including the&#xD;
                  day of study vaccination (Flu and Hib vaccines must be administered at a&#xD;
                  different location than the study vaccine/s).&#xD;
&#xD;
               -  Any age appropriate vaccine may be given starting at Visit 2 (or starting at&#xD;
                  Visit 3 for the US post-dose 2 sub-cohort), and anytime thereafter.&#xD;
&#xD;
          -  Administration of immunoglobulins and/or any blood products during the period starting&#xD;
             180 days prior to study vaccination at Visit 1 or planned administration from the date&#xD;
             of vaccination through the immunogenicity evaluation at Visit 2, or at Visit 3 for the&#xD;
             US post-dose 2 sub-cohort.&#xD;
&#xD;
          -  History of measles, mumps, rubella, varicella/zoster and/or hepatitis A diseases.&#xD;
&#xD;
          -  Known exposure to measles, mumps, rubella and/or varicella/zoster during the period&#xD;
             starting 30 days prior to the 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.&#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;
          -  Blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms&#xD;
             affecting the bone marrow or lymphatic systems.&#xD;
&#xD;
          -  Acute disease at the time of enrollment. Acute disease is defined as the presence of a&#xD;
             moderate or severe illness with or without fever. Fever is defined as temperature&#xD;
             ≥38°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:&#xD;
&#xD;
        • A child that previously received a fourth dose of any pneumococcal conjugate 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>Phoenix</city>
        <state>Arizona</state>
        <zip>85012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85032</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>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>West Covina</city>
        <state>California</state>
        <zip>91790</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Altamonte Springs</city>
        <state>Florida</state>
        <zip>32701</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>Miami</city>
        <state>Florida</state>
        <zip>33184</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Naples</city>
        <state>Florida</state>
        <zip>34102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Muncie</city>
        <state>Indiana</state>
        <zip>47304-5547</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>New Albany</city>
        <state>Indiana</state>
        <zip>47150</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>West Des Moines</city>
        <state>Iowa</state>
        <zip>50265</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Annapolis</city>
        <state>Maryland</state>
        <zip>21401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</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>Kansas City</city>
        <state>Missouri</state>
        <zip>64108</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>Omaha</city>
        <state>Nebraska</state>
        <zip>68131</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>Cleveland</city>
        <state>Ohio</state>
        <zip>44121</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>Toledo</city>
        <state>Ohio</state>
        <zip>43606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Youngstown</city>
        <state>Ohio</state>
        <zip>44514</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Gresham</city>
        <state>Oregon</state>
        <zip>97030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Johnstown</city>
        <state>Pennsylvania</state>
        <zip>15904</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>Charleston</city>
        <state>South Carolina</state>
        <zip>29414</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77087</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>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>Springville</city>
        <state>Utah</state>
        <zip>84663</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Midlothian</city>
        <state>Virginia</state>
        <zip>23113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23223</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>Benesov</city>
        <zip>256 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Chlumec nad Cidlinou</city>
        <zip>50351</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Decin</city>
        <zip>405 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Jindrichuv Hradec</city>
        <zip>37701</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kladno</city>
        <zip>272 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Liberec</city>
        <zip>46015</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Lipnik nad Becvou</city>
        <zip>75131</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Nachod</city>
        <zip>547 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Odolena voda</city>
        <zip>25070</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ostrava - Poruba</city>
        <zip>70800</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Pardubice</city>
        <zip>532 03</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Praha 6</city>
        <zip>1600</zip>
        <country>Czechia</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>Oulu</city>
        <zip>90220</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>Kuala Terengganu</city>
        <zip>20400</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kuching</city>
        <zip>93586</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sibu</city>
        <zip>96000</zip>
        <country>Malaysia</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>Antequera/Málaga</city>
        <zip>29200</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Barcelona</city>
        <zip>08042</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Centelles (Barcelona)</city>
        <zip>08540</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>L'Eliana, Valencia</city>
        <zip>46183</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Manlleu</city>
        <zip>08560</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Quart De Poblet, Valencia</city>
        <zip>46930</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Santiago de Compostela</city>
        <zip>15706</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sevilla</city>
        <zip>41014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Valencia</city>
        <zip>46020</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Valencia</city>
        <zip>46024</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Valencia</city>
        <zip>46200</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Vic</city>
        <zip>08500</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bangkok</city>
        <zip>10330</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bangkok</city>
        <zip>10400</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bangkok</city>
        <zip>10700</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Chiang mai</city>
        <zip>50200</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Pathum Thani</city>
        <zip>12120</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czechia</country>
    <country>Finland</country>
    <country>Malaysia</country>
    <country>Puerto Rico</country>
    <country>Spain</country>
    <country>Thailand</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
  </removed_countries>
  <reference>
    <citation>MMR-161 Study Group. Immunogenicity and safety of measles-mumps-rubella vaccine at two different potency levels administered to healthy children aged 12-15 months: A phase III, randomized, non-inferiority trial. Vaccine. 2018 Sep 11;36(38):5781-5788. doi: 10.1016/j.vaccine.2018.07.076. Epub 2018 Aug 10.</citation>
    <PMID>30104117</PMID>
  </reference>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>September 6, 2012</study_first_submitted>
  <study_first_submitted_qc>September 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2012</study_first_posted>
  <results_first_submitted>December 30, 2016</results_first_submitted>
  <results_first_submitted_qc>July 19, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">August 17, 2018</results_first_posted>
  <disposition_first_submitted>April 7, 2016</disposition_first_submitted>
  <disposition_first_submitted_qc>April 7, 2016</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">May 4, 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>Safety</keyword>
  <keyword>Measles, mumps and rubella diseases</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>US sub-cohort: Subjects recruited in US and received Inv_MMR_Min or Inv_MMR_Med or Com_MMR (Lot 1 or 2) co-administered with Varivax (VV), Havrix (HAV) and Prevnar 13 (PCV-13) at Day 0. Non-US sub-cohort: Subjects recruited outside US and received Inv_MMR_Min or Inv_MMR_Med or Com_MMR (Lot 1 or 2) co-administered with VV and HAV at Day 0.</recruitment_details>
      <pre_assignment_details>4538 subjects were registered in the study. 3 subjects were excluded because of invalid Informed Consent Forms and 19 subjects received a subject number but were not vaccinated. Therefore, the number of subjects started is 4516.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Inv_MMR_Min Group</title>
          <description>Subjects received one dose of GlaxoSmithKline (GSK) Biologicals' measles, mumps, rubella (MMR) vaccine, Priorix (Inv_MMR), from a minimum potency lot (Inv_MMR_Min), co-administered with Varivax (VV) and Havrix (HAV) vaccines at Day 0. All US subjects were also co-administered Prevnar 13 (PCV-13) vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
        </group>
        <group group_id="P2">
          <title>Inv_MMR_Med Group</title>
          <description>Subjects received one dose of GlaxoSmithKline (GSK) Biologicals' measles, mumps, rubella (MMR) vaccine, Priorix (Inv_MMR), from a mid-range or medium potency lot (Inv_MMR_Med), co-administered with Varivax (VV) and Havrix (HAV) vaccines at Day 0. All US subjects were also co-administered Prevnar 13 (PCV-13) vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
        </group>
        <group group_id="P3">
          <title>Com_MMR Group</title>
          <description>Subjects received one dose of M-M-R II (Com_MMR) vaccine (Lot 1 or Lot 2), co-administered with Varivax (VV) and Havrix (HAV) vaccines at Day 0. All US subjects were also co-administered Prevnar 13 (PCV-13) vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1493"/>
                <participants group_id="P2" count="1497"/>
                <participants group_id="P3" count="1526"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1427"/>
                <participants group_id="P2" count="1427"/>
                <participants group_id="P3" count="1443"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="66"/>
                <participants group_id="P2" count="70"/>
                <participants group_id="P3" count="83"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
                <participants group_id="P2" count="38"/>
                <participants group_id="P3" count="53"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>As Per Sponsor Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="30"/>
                <participants group_id="P3" count="25"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Inv_MMR_Min Group</title>
          <description>Subjects received one dose of Inv_MMR, from a minimum potency lot (Inv_MMR_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
        </group>
        <group group_id="B2">
          <title>Inv_MMR_Med Group</title>
          <description>Subjects received one dose of Inv_MMR, from a mid-range or medium potency lot (Inv_MMR_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
        </group>
        <group group_id="B3">
          <title>Com_MMR Group</title>
          <description>Subjects received one dose of Com_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1493"/>
            <count group_id="B2" value="1497"/>
            <count group_id="B3" value="1526"/>
            <count group_id="B4" value="4516"/>
          </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="12.6" spread="0.9"/>
                    <measurement group_id="B2" value="12.6" spread="0.9"/>
                    <measurement group_id="B3" value="12.6" spread="0.9"/>
                    <measurement group_id="B4" value="12.6" spread="0.9"/>
                  </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="704"/>
                    <measurement group_id="B2" value="718"/>
                    <measurement group_id="B3" value="758"/>
                    <measurement group_id="B4" value="2180"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="789"/>
                    <measurement group_id="B2" value="779"/>
                    <measurement group_id="B3" value="768"/>
                    <measurement group_id="B4" value="2336"/>
                  </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="45"/>
                    <measurement group_id="B2" value="53"/>
                    <measurement group_id="B3" value="46"/>
                    <measurement group_id="B4" value="144"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>American Indian or Alaskan Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian - Central/South Asian Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian - East Asian Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian - South East Asian Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="362"/>
                    <measurement group_id="B2" value="366"/>
                    <measurement group_id="B3" value="367"/>
                    <measurement group_id="B4" value="1095"/>
                  </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="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White - Arabic / North African Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White - Caucasian / European Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1017"/>
                    <measurement group_id="B2" value="1022"/>
                    <measurement group_id="B3" value="1052"/>
                    <measurement group_id="B4" value="3091"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="49"/>
                    <measurement group_id="B4" value="150"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value (by Enzyme-linked Immunosorbent Assay [ELISA])</title>
        <description>For measles virus, a seroresponse was defined as post-vaccination anti-measles virus antibody concentration equal or above [≥] 200 mIU/mL (ELISA) among subjects who were seronegative (antibody concentration less than [&lt;] 150 mIU/mL) before dose 1. Criteria to demonstrate an acceptable immune response of Inv_MMR_Min/Inv_MMR_Med vaccine in terms of seroresponse rate for measles virus at Day 42: The lower limit of the two-sided 97.5% CI for the seroresponse rate of Inv_MMR_Min/Inv_MMR_Med was to be ≥ 90% for antibodies to measles virus.</description>
        <time_frame>At Day 42</time_frame>
        <population>According-to-protocol (ATP) cohort for analysis of immunogenicity post dose 1: all eligible subjects with pre- &amp; post-dose 1 serology results &amp; were below assay cut-off for at least 1 vaccine antigen for MMR at pre-vaccination, did not meet elimination criteria up to Day 42 blood sample &amp; complied with post-dose 1 blood sample schedule.</population>
        <group_list>
          <group group_id="O1">
            <title>Inv_MMR_Min Group</title>
            <description>Subjects received one dose of Inv_MMR, from a minimum potency lot (Inv_MMR_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O2">
            <title>Inv_MMR_Med Group</title>
            <description>Subjects received one dose of Inv_MMR, from a mid-range or medium potency lot (Inv_MMR_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O3">
            <title>Com_MMR Group</title>
            <description>Subjects received one dose of Com_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value (by Enzyme-linked Immunosorbent Assay [ELISA])</title>
          <description>For measles virus, a seroresponse was defined as post-vaccination anti-measles virus antibody concentration equal or above [≥] 200 mIU/mL (ELISA) among subjects who were seronegative (antibody concentration less than [&lt;] 150 mIU/mL) before dose 1. Criteria to demonstrate an acceptable immune response of Inv_MMR_Min/Inv_MMR_Med vaccine in terms of seroresponse rate for measles virus at Day 42: The lower limit of the two-sided 97.5% CI for the seroresponse rate of Inv_MMR_Min/Inv_MMR_Med was to be ≥ 90% for antibodies to measles virus.</description>
          <population>According-to-protocol (ATP) cohort for analysis of immunogenicity post dose 1: all eligible subjects with pre- &amp; post-dose 1 serology results &amp; were below assay cut-off for at least 1 vaccine antigen for MMR at pre-vaccination, did not meet elimination criteria up to Day 42 blood sample &amp; complied with post-dose 1 blood sample schedule.</population>
          <units>Percentage of subjects</units>
          <param>Number</param>
          <dispersion>97.5% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1361"/>
                <count group_id="O2" value="1366"/>
                <count group_id="O3" value="1378"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Anti-measles ≥ 150 mIU/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.9" lower_limit="89.0" upper_limit="92.6"/>
                    <measurement group_id="O2" value="94.3" lower_limit="92.7" upper_limit="95.6"/>
                    <measurement group_id="O3" value="96.5" lower_limit="95.2" upper_limit="97.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anti-measles ≥ 200 mIU/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.8" lower_limit="88.9" upper_limit="92.5"/>
                    <measurement group_id="O2" value="94.2" lower_limit="92.6" upper_limit="95.5"/>
                    <measurement group_id="O3" value="96.3" lower_limit="95.0" upper_limit="97.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Non-inferiority of Inv_MMR_Min vaccine compared to Com_MMR vaccine in terms of seroresponse rate to measles virus at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The lower limit of the 2-sided 97.5% confidence interval (CI) on the group difference (Inv_MMR_Min minus Com_MMR) in seroresponse rate should be ≥ -5% for antibodies to measles virus when tested with ELISA.</non_inferiority_desc>
            <param_type>Difference in seroresponse rate</param_type>
            <param_value>-5.48</param_value>
            <ci_percent>97.5</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.65</ci_lower_limit>
            <ci_upper_limit>-3.43</ci_upper_limit>
            <estimate_desc>Asymptotic standardized 97.5% CI for the difference in seroresponse rate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Non-inferiority of Inv_MMR_Med vaccine compared to Com_MMR vaccine in terms of seroresponse rate to measles virus at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The lower limit of the 2-sided 97.5% confidence interval (CI) on the group difference (Inv_MMR_Med minus Com_MMR) in seroresponse rate should be ≥ -5% for antibodies to measles virus when tested with ELISA.</non_inferiority_desc>
            <param_type>Difference in seroresponse rate</param_type>
            <param_value>-2.08</param_value>
            <ci_percent>97.5</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.96</ci_lower_limit>
            <ci_upper_limit>-0.27</ci_upper_limit>
            <estimate_desc>Asymptotic standardized 97.5% CI for the difference in seroresponse rate.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA)</title>
        <description>For mumps virus, a seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 10 EU/mL (ELISA) among subjects who were seronegative (antibody concentration &lt; 5 EU/mL) before dose 1. Criteria to demonstrate an acceptable immune response of Inv_MMR_Min/Inv_MMR_Med vaccine in terms of seroresponse rate for mumps virus at Day 42: The lower limit of the two-sided 97.5% CI for the seroresponse rate of Inv_MMR_Min/Inv_MMR_Med was to be ≥ 90% for antibodies to mumps virus.</description>
        <time_frame>At Day 42</time_frame>
        <population>ATP cohort for analysis of immunogenicity post dose 1: all eligible subjects with pre- &amp; post-dose 1 serology results &amp; were below assay cut-off for at least 1 vaccine antigen for MMR at pre-vaccination, did not meet elimination criteria up to Day 42 blood sample &amp; complied with post-dose 1 blood sample schedule.</population>
        <group_list>
          <group group_id="O1">
            <title>Inv_MMR_Min Group</title>
            <description>Subjects received one dose of Inv_MMR, from a minimum potency lot (Inv_MMR_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O2">
            <title>Inv_MMR_Med Group</title>
            <description>Subjects received one dose of Inv_MMR, from a mid-range or medium potency lot (Inv_MMR_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O3">
            <title>Com_MMR Group</title>
            <description>Subjects received one dose of Com_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA)</title>
          <description>For mumps virus, a seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 10 EU/mL (ELISA) among subjects who were seronegative (antibody concentration &lt; 5 EU/mL) before dose 1. Criteria to demonstrate an acceptable immune response of Inv_MMR_Min/Inv_MMR_Med vaccine in terms of seroresponse rate for mumps virus at Day 42: The lower limit of the two-sided 97.5% CI for the seroresponse rate of Inv_MMR_Min/Inv_MMR_Med was to be ≥ 90% for antibodies to mumps virus.</description>
          <population>ATP cohort for analysis of immunogenicity post dose 1: all eligible subjects with pre- &amp; post-dose 1 serology results &amp; were below assay cut-off for at least 1 vaccine antigen for MMR at pre-vaccination, did not meet elimination criteria up to Day 42 blood sample &amp; complied with post-dose 1 blood sample schedule.</population>
          <units>Percentage of subjects</units>
          <param>Number</param>
          <dispersion>97.5% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1161"/>
                <count group_id="O2" value="1131"/>
                <count group_id="O3" value="1155"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Anti-mumps ≥ 5 EU/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.1" lower_limit="98.2" upper_limit="99.6"/>
                    <measurement group_id="O2" value="99.0" lower_limit="98.1" upper_limit="99.6"/>
                    <measurement group_id="O3" value="99.2" lower_limit="98.4" upper_limit="99.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anti-mumps ≥ 10 EU/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.4" lower_limit="96.2" upper_limit="98.3"/>
                    <measurement group_id="O2" value="97.3" lower_limit="96.0" upper_limit="98.2"/>
                    <measurement group_id="O3" value="97.8" lower_limit="96.7" upper_limit="98.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Non-inferiority of Inv_MMR_Min vaccine compared to Com_MMR vaccine in terms of seroresponse rate to mumps virus at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The lower limit of the 2-sided 97.5% CI on the group difference (Inv_MMR_Min minus Com_MMR) in seroresponse rate should be ≥ -5% for antibodies to mumps virus when tested with ELISA.</non_inferiority_desc>
            <param_type>Difference in seroresponse rate</param_type>
            <param_value>-0.42</param_value>
            <ci_percent>97.5</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.91</ci_lower_limit>
            <ci_upper_limit>1.04</ci_upper_limit>
            <estimate_desc>Asymptotic standardized 97.5% CI for the difference in seroresponse rate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Non-inferiority of Inv_MMR_Med vaccine compared to Com_MMR vaccine in terms of seroresponse rate to mumps virus at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The lower limit of the 2-sided 97.5% CI on the group difference (Inv_MMR_Med minus Com_MMR) in seroresponse rate should be ≥ -5% for antibodies to mumps virus when tested with ELISA.</non_inferiority_desc>
            <param_type>Difference in seroresponse rate</param_type>
            <param_value>-0.58</param_value>
            <ci_percent>97.5</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.11</ci_lower_limit>
            <ci_upper_limit>0.91</ci_upper_limit>
            <estimate_desc>Asymptotic standardized 97.5% CI for the difference in seroresponse rate.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value (by Plaque Reduction Neutralization Test [PRNT])</title>
        <description>For mumps virus as measured by PRNT, a seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 4 End point Dilution 50% (ED50) (PRNT) among subjects who were seronegative (antibody concentration &lt; 2.5 ED50) before dose 1.</description>
        <time_frame>At Day 42</time_frame>
        <population>ATP cohort for analysis of immunogenicity post dose 1: all eligible subjects with pre- &amp; post-dose 1 serology results &amp; were below assay cut-off for at least 1 vaccine antigen for MMR at pre-vaccination, did not meet elimination criteria up to Day 42 blood sample &amp; complied with post-dose 1 blood sample schedule.</population>
        <group_list>
          <group group_id="O1">
            <title>Inv_MMR_Min Group</title>
            <description>Subjects received one dose of Inv_MMR, from a minimum potency lot (Inv_MMR_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O2">
            <title>Inv_MMR_Med Group</title>
            <description>Subjects received one dose of Inv_MMR, from a mid-range or medium potency lot (Inv_MMR_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O3">
            <title>Com_MMR Group</title>
            <description>Subjects received one dose of Com_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value (by Plaque Reduction Neutralization Test [PRNT])</title>
          <description>For mumps virus as measured by PRNT, a seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 4 End point Dilution 50% (ED50) (PRNT) among subjects who were seronegative (antibody concentration &lt; 2.5 ED50) before dose 1.</description>
          <population>ATP cohort for analysis of immunogenicity post dose 1: all eligible subjects with pre- &amp; post-dose 1 serology results &amp; were below assay cut-off for at least 1 vaccine antigen for MMR at pre-vaccination, did not meet elimination criteria up to Day 42 blood sample &amp; complied with post-dose 1 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="1252"/>
                <count group_id="O2" value="1265"/>
                <count group_id="O3" value="1287"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>≥ 2.5 ED50</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.1" lower_limit="76.7" upper_limit="81.3"/>
                    <measurement group_id="O2" value="81.6" lower_limit="79.3" upper_limit="83.7"/>
                    <measurement group_id="O3" value="87.5" lower_limit="85.6" upper_limit="89.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 4 ED50</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.2" lower_limit="68.6" upper_limit="73.7"/>
                    <measurement group_id="O2" value="73.4" lower_limit="70.8" upper_limit="75.8"/>
                    <measurement group_id="O3" value="80.6" lower_limit="78.3" upper_limit="82.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Non-inferiority of Inv_MMR_Min vaccine compared to Com_MMR vaccine in terms of seroresponse rate to mumps virus at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The lower limit of the 2-sided 97.5% CI on the group difference (Inv_MMR_Min minus Com_MMR) in seroresponse rate should be ≥ -10% for antibodies to mumps virus when tested with PRNT.</non_inferiority_desc>
            <param_type>Difference in seroresponse rate</param_type>
            <param_value>-9.41</param_value>
            <ci_percent>97.5</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.20</ci_lower_limit>
            <ci_upper_limit>-5.62</ci_upper_limit>
            <estimate_desc>Asymptotic standardized 97.5% CI for the difference in seroresponse rate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Non-inferiority of Inv_MMR_Med vaccine compared to Com_MMR vaccine in terms of seroresponse rate to mumps virus at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The lower limit of the 2-sided 97.5% CI on the group difference (Inv_MMR_Med minus Com_MMR) in seroresponse rate should be ≥ -10% for antibodies to mumps virus when tested with PRNT.</non_inferiority_desc>
            <param_type>Difference in seroresponse rate</param_type>
            <param_value>-7.22</param_value>
            <ci_percent>97.5</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.94</ci_lower_limit>
            <ci_upper_limit>-3.49</ci_upper_limit>
            <estimate_desc>Asymptotic standardized 97.5% CI for the difference in seroresponse rate.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA)</title>
        <description>For rubella virus, a seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥ 10 IU/mL (ELISA) among subjects who were seronegative (antibody concentration &lt; 4 IU/mL) before dose 1. Criteria to demonstrate an acceptable immune response of Inv_MMR_Min/Inv_MMR_Med vaccine in terms of seroresponse rate for rubella virus at Day 42: The lower limit of the two-sided 97.5% CI for the seroresponse rate of Inv_MMR_Min/Inv_MMR_Med was to be ≥ 90% for antibodies to mumps virus.</description>
        <time_frame>At Day 42</time_frame>
        <population>ATP cohort for analysis of immunogenicity post dose 1: all eligible subjects with pre- &amp; post-dose 1 serology results &amp; were below assay cut-off for at least 1 vaccine antigen for MMR at pre-vaccination, did not meet elimination criteria up to Day 42 blood sample &amp; complied with post-dose 1 blood sample schedule.</population>
        <group_list>
          <group group_id="O1">
            <title>Inv_MMR_Min Group</title>
            <description>Subjects received one dose of Inv_MMR, from a minimum potency lot (Inv_MMR_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O2">
            <title>Inv_MMR_Med Group</title>
            <description>Subjects received one dose of Inv_MMR, from a mid-range or medium potency lot (Inv_MMR_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O3">
            <title>Com_MMR Group</title>
            <description>Subjects received one dose of Com_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA)</title>
          <description>For rubella virus, a seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥ 10 IU/mL (ELISA) among subjects who were seronegative (antibody concentration &lt; 4 IU/mL) before dose 1. Criteria to demonstrate an acceptable immune response of Inv_MMR_Min/Inv_MMR_Med vaccine in terms of seroresponse rate for rubella virus at Day 42: The lower limit of the two-sided 97.5% CI for the seroresponse rate of Inv_MMR_Min/Inv_MMR_Med was to be ≥ 90% for antibodies to mumps virus.</description>
          <population>ATP cohort for analysis of immunogenicity post dose 1: all eligible subjects with pre- &amp; post-dose 1 serology results &amp; were below assay cut-off for at least 1 vaccine antigen for MMR at pre-vaccination, did not meet elimination criteria up to Day 42 blood sample &amp; complied with post-dose 1 blood sample schedule.</population>
          <units>Percentage of subjects</units>
          <param>Number</param>
          <dispersion>97.5% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1359"/>
                <count group_id="O2" value="1366"/>
                <count group_id="O3" value="1376"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>≥ 4 IU/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="99.5" lower_limit="98.9" upper_limit="99.8"/>
                    <measurement group_id="O3" value="99.5" lower_limit="98.9" upper_limit="99.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 10 IU/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.8" lower_limit="95.5" upper_limit="97.7"/>
                    <measurement group_id="O2" value="97.3" lower_limit="96.1" upper_limit="98.2"/>
                    <measurement group_id="O3" value="98.5" lower_limit="97.6" upper_limit="99.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Non-inferiority of Inv_MMR_Min vaccine compared to Com_MMR vaccine in terms of seroresponse rate to rubella virus at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The lower limit of the 2-sided 97.5% CI on the group difference (Inv_MMR_Min minus Com_MMR) in seroresponse rate should be ≥ -5% for antibodies to rubella virus when tested with ELISA.</non_inferiority_desc>
            <param_type>Difference in seroresponse rate</param_type>
            <param_value>-1.71</param_value>
            <ci_percent>97.5</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.11</ci_lower_limit>
            <ci_upper_limit>-0.42</ci_upper_limit>
            <estimate_desc>Asymptotic standardized 97.5% CI for the difference in seroresponse rate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Non-inferiority of Inv_MMR_Med vaccine compared to Com_MMR vaccine in terms of seroresponse rate to rubella virus at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The lower limit of the 2-sided 97.5% CI on the group difference (Inv_MMR_Med minus Com_MMR) in seroresponse rate should be ≥ -5% for antibodies to rubella virus when tested with ELISA.</non_inferiority_desc>
            <param_type>Difference in seroresponse rate</param_type>
            <param_value>-1.18</param_value>
            <ci_percent>97.5</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.50</ci_lower_limit>
            <ci_upper_limit>0.05</ci_upper_limit>
            <estimate_desc>Asymptotic standardized 97.5% CI for the difference in seroresponse rate.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Anti-measles Virus Antibody Concentrations (by ELISA)</title>
        <description>Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL.</description>
        <time_frame>At Day 42</time_frame>
        <population>ATP cohort for analysis of immunogenicity post dose 1: all eligible subjects with pre- &amp; post-dose 1 serology results &amp; were below assay cut-off for at least 1 vaccine antigen for MMR at pre-vaccination, did not meet elimination criteria up to Day 42 blood sample &amp; complied with post-dose 1 blood sample schedule.</population>
        <group_list>
          <group group_id="O1">
            <title>Inv_MMR_Min Group</title>
            <description>Subjects received one dose of Inv_MMR, from a minimum potency lot (Inv_MMR_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O2">
            <title>Inv_MMR_Med Group</title>
            <description>Subjects received one dose of Inv_MMR, from a mid-range or medium potency lot (Inv_MMR_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O3">
            <title>Com_MMR Group</title>
            <description>Subjects received one dose of Com_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
        </group_list>
        <measure>
          <title>Anti-measles Virus Antibody Concentrations (by ELISA)</title>
          <description>Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL.</description>
          <population>ATP cohort for analysis of immunogenicity post dose 1: all eligible subjects with pre- &amp; post-dose 1 serology results &amp; were below assay cut-off for at least 1 vaccine antigen for MMR at pre-vaccination, did not meet elimination criteria up to Day 42 blood sample &amp; complied with post-dose 1 blood sample schedule.</population>
          <units>mIU/mL</units>
          <param>Geometric Mean</param>
          <dispersion>97.5% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1361"/>
                <count group_id="O2" value="1366"/>
                <count group_id="O3" value="1378"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2209.9" lower_limit="2041.3" upper_limit="2392.4"/>
                    <measurement group_id="O2" value="2540.9" lower_limit="2368.8" upper_limit="2725.5"/>
                    <measurement group_id="O3" value="2787.7" lower_limit="2619.5" upper_limit="2966.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Non-inferiority of Inv_MMR_Min vaccine compared to COM_MMR vaccine in terms of GMCs for anti-measles antibodies at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv_MMR_Min over pooled Com_MMR) should to be ≥ 0.67 for antibodies to measles virus when tested with ELISA.</non_inferiority_desc>
            <param_type>Adjusted GMC ratio</param_type>
            <param_value>0.79</param_value>
            <ci_percent>97.5</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.72</ci_lower_limit>
            <ci_upper_limit>0.88</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Non-inferiority of Inv_MMR_Med vaccine compared to COM_MMR vaccine in terms of GMCs for anti-measles antibodies at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv_MMR_Med over pooled Com_MMR) should to be ≥ 0.67 for antibodies to measles virus when tested with ELISA.</non_inferiority_desc>
            <param_type>Adjusted GMC ratio</param_type>
            <param_value>0.91</param_value>
            <ci_percent>97.5</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.83</ci_lower_limit>
            <ci_upper_limit>1.01</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Anti-mumps Virus Antibody Concentrations (by ELISA)</title>
        <description>Antibody concentrations were expressed as GMCs in EU/mL.</description>
        <time_frame>At Day 42</time_frame>
        <population>ATP cohort for analysis of immunogenicity post dose 1: all eligible subjects with pre- &amp; post-dose 1 serology results &amp; were below assay cut-off for at least 1 vaccine antigen for MMR at pre-vaccination, did not meet elimination criteria up to Day 42 blood sample &amp; complied with post-dose 1 blood sample schedule.</population>
        <group_list>
          <group group_id="O1">
            <title>Inv_MMR_Min Group</title>
            <description>Subjects received one dose of Inv_MMR, from a minimum potency lot (Inv_MMR_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O2">
            <title>Inv_MMR_Med Group</title>
            <description>Subjects received one dose of Inv_MMR, from a mid-range or medium potency lot (Inv_MMR_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O3">
            <title>Com_MMR Group</title>
            <description>Subjects received one dose of Com_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
        </group_list>
        <measure>
          <title>Anti-mumps Virus Antibody Concentrations (by ELISA)</title>
          <description>Antibody concentrations were expressed as GMCs in EU/mL.</description>
          <population>ATP cohort for analysis of immunogenicity post dose 1: all eligible subjects with pre- &amp; post-dose 1 serology results &amp; were below assay cut-off for at least 1 vaccine antigen for MMR at pre-vaccination, did not meet elimination criteria up to Day 42 blood sample &amp; complied with post-dose 1 blood sample schedule.</population>
          <units>EU/mL</units>
          <param>Geometric Mean</param>
          <dispersion>97.5% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1161"/>
                <count group_id="O2" value="1131"/>
                <count group_id="O3" value="1155"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.7" lower_limit="55.5" upper_limit="62.1"/>
                    <measurement group_id="O2" value="60.2" lower_limit="56.8" upper_limit="63.7"/>
                    <measurement group_id="O3" value="71.6" lower_limit="67.7" upper_limit="75.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Non-inferiority of Inv_MMR_Min vaccine compared to COM_MMR vaccine in terms of GMCs for anti-mumps antibodies at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv_MMR_Min over pooled Com_MMR) should to be ≥ 0.67 for antibodies to mumps virus when tested with ELISA.</non_inferiority_desc>
            <param_type>Adjusted GMC ratio</param_type>
            <param_value>0.82</param_value>
            <ci_percent>97.5</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.76</ci_lower_limit>
            <ci_upper_limit>0.89</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Non-inferiority of Inv_MMR_Med vaccine compared to COM_MMR vaccine in terms of GMCs for anti-mumps antibodies at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv_MMR_Med over pooled Com_MMR) should to be ≥ 0.67 for antibodies to mumps virus when tested with ELISA.</non_inferiority_desc>
            <param_type>Adjusted GMC ratio</param_type>
            <param_value>0.84</param_value>
            <ci_percent>97.5</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.78</ci_lower_limit>
            <ci_upper_limit>0.91</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Anti-mumps Virus Antibody Concentrations (by PRNT)</title>
        <description>Antibody concentrations were expressed as Geometric Mean Titers (GMTs).</description>
        <time_frame>At Day 42</time_frame>
        <population>ATP cohort for analysis of immunogenicity post dose 1: all eligible subjects with pre- &amp; post-dose 1 serology results &amp; were below assay cut-off for at least 1 vaccine antigen for MMR at pre-vaccination, did not meet elimination criteria up to Day 42 blood sample &amp; complied with post-dose 1 blood sample schedule.</population>
        <group_list>
          <group group_id="O1">
            <title>Inv_MMR_Min Group</title>
            <description>Subjects received one dose of Inv_MMR, from a minimum potency lot (Inv_MMR_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O2">
            <title>Inv_MMR_Med Group</title>
            <description>Subjects received one dose of Inv_MMR, from a mid-range or medium potency lot (Inv_MMR_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O3">
            <title>Com_MMR Group</title>
            <description>Subjects received one dose of Com_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
        </group_list>
        <measure>
          <title>Anti-mumps Virus Antibody Concentrations (by PRNT)</title>
          <description>Antibody concentrations were expressed as Geometric Mean Titers (GMTs).</description>
          <population>ATP cohort for analysis of immunogenicity post dose 1: all eligible subjects with pre- &amp; post-dose 1 serology results &amp; were below assay cut-off for at least 1 vaccine antigen for MMR at pre-vaccination, did not meet elimination criteria up to Day 42 blood sample &amp; complied with post-dose 1 blood sample schedule.</population>
          <units>Titers</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="1252"/>
                <count group_id="O2" value="1265"/>
                <count group_id="O3" value="1287"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.8" lower_limit="9.0" upper_limit="10.6"/>
                    <measurement group_id="O2" value="10.7" lower_limit="9.9" upper_limit="11.5"/>
                    <measurement group_id="O3" value="16.3" lower_limit="15.1" upper_limit="17.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Non-inferiority of Inv_MMR_Min vaccine compared to COM_MMR vaccine in terms of GMCs for anti-mumps antibodies at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv_MMR_Min over pooled Com_MMR) should to be ≥ 0.67 for antibodies to mumps virus when tested with PRNT.</non_inferiority_desc>
            <param_type>Adjusted GMT ratio</param_type>
            <param_value>0.60</param_value>
            <ci_percent>97.5</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.53</ci_lower_limit>
            <ci_upper_limit>0.68</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Non-inferiority of Inv_MMR_Med vaccine compared to COM_MMR vaccine in terms of GMCs for anti-mumps antibodies at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv_MMR_Med over pooled Com_MMR) should to be ≥ 0.67 for antibodies to mumps virus when tested with PRNT.</non_inferiority_desc>
            <param_type>Adjusted GMT ratio</param_type>
            <param_value>0.65</param_value>
            <ci_percent>97.5</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.57</ci_lower_limit>
            <ci_upper_limit>0.74</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Anti-rubella Virus Antibody Concentrations (by ELISA)</title>
        <description>Antibody concentrations were expressed as GMCs in IU/mL.</description>
        <time_frame>At Day 42</time_frame>
        <population>ATP cohort for analysis of immunogenicity post dose 1: all eligible subjects with pre- &amp; post-dose 1 serology results &amp; were below assay cut-off for at least 1 vaccine antigen for MMR at pre-vaccination, did not meet elimination criteria up to Day 42 blood sample &amp; complied with post-dose 1 blood sample schedule.</population>
        <group_list>
          <group group_id="O1">
            <title>Inv_MMR_Min Group</title>
            <description>Subjects received one dose of Inv_MMR, from a minimum potency lot (Inv_MMR_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O2">
            <title>Inv_MMR_Med Group</title>
            <description>Subjects received one dose of Inv_MMR, from a mid-range or medium potency lot (Inv_MMR_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O3">
            <title>Com_MMR Group</title>
            <description>Subjects received one dose of Com_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
        </group_list>
        <measure>
          <title>Anti-rubella Virus Antibody Concentrations (by ELISA)</title>
          <description>Antibody concentrations were expressed as GMCs in IU/mL.</description>
          <population>ATP cohort for analysis of immunogenicity post dose 1: all eligible subjects with pre- &amp; post-dose 1 serology results &amp; were below assay cut-off for at least 1 vaccine antigen for MMR at pre-vaccination, did not meet elimination criteria up to Day 42 blood sample &amp; complied with post-dose 1 blood sample schedule.</population>
          <units>IU/mL</units>
          <param>Geometric Mean</param>
          <dispersion>97.5% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1359"/>
                <count group_id="O2" value="1366"/>
                <count group_id="O3" value="1376"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.0" lower_limit="54.1" upper_limit="60.0"/>
                    <measurement group_id="O2" value="56.9" lower_limit="54.2" upper_limit="59.8"/>
                    <measurement group_id="O3" value="64.4" lower_limit="61.4" upper_limit="67.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Non-inferiority of Inv_MMR_Min vaccine compared to COM_MMR vaccine in terms of GMCs for anti-rubella antibodies at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv_MMR_Min over pooled Com_MMR) should to be ≥ 0.67 for antibodies to rubella virus when tested with ELISA.</non_inferiority_desc>
            <param_type>Adjusted GMC ratio</param_type>
            <param_value>0.89</param_value>
            <ci_percent>97.5</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.83</ci_lower_limit>
            <ci_upper_limit>0.95</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Non-inferiority of Inv_MMR_Med vaccine compared to COM_MMR vaccine in terms of GMCs for anti-rubella antibodies at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv_MMR_Med over pooled Com_MMR) should to be ≥ 0.67 for antibodies to rubella virus when tested with ELISA.</non_inferiority_desc>
            <param_type>Adjusted GMC ratio</param_type>
            <param_value>0.88</param_value>
            <ci_percent>97.5</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.83</ci_lower_limit>
            <ci_upper_limit>0.95</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 (by ELISA)</title>
        <description>For measles virus, a seroresponse was defined as post-vaccination anti-measles virus antibody concentration ≥ 200 mIU/mL (ELISA) among subjects who were seronegative (antibody concentration &lt; 150 mIU/mL) before dose 1.</description>
        <time_frame>At Day 84</time_frame>
        <population>ATP cohort for analysis of immunogenicity post dose 2: all eligible subjects from US sub-cohort who received 2 doses of Inv_MMR/Com_MMR vaccine, with pre- &amp; post-dose 2 serology results for at least 1 vaccine antigen for MMR, did not meet elimination criteria up to Day 84 blood sample &amp; complied with post-dose 2 blood sample schedule.</population>
        <group_list>
          <group group_id="O1">
            <title>Inv_MMR_Min Group</title>
            <description>Subjects received one dose of Inv_MMR, from a minimum potency lot (Inv_MMR_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O2">
            <title>Inv_MMR_Med Group</title>
            <description>Subjects received one dose of Inv_MMR, from a mid-range or medium potency lot (Inv_MMR_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O3">
            <title>Com_MMR Group</title>
            <description>Subjects received one dose of Com_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA)</title>
          <description>For measles virus, a seroresponse was defined as post-vaccination anti-measles virus antibody concentration ≥ 200 mIU/mL (ELISA) among subjects who were seronegative (antibody concentration &lt; 150 mIU/mL) before dose 1.</description>
          <population>ATP cohort for analysis of immunogenicity post dose 2: all eligible subjects from US sub-cohort who received 2 doses of Inv_MMR/Com_MMR vaccine, with pre- &amp; post-dose 2 serology results for at least 1 vaccine antigen for MMR, did not meet elimination criteria up to Day 84 blood sample &amp; complied with post-dose 2 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="245"/>
                <count group_id="O2" value="258"/>
                <count group_id="O3" value="257"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>≥ 150 mIU/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.6" lower_limit="97.7" upper_limit="100"/>
                    <measurement group_id="O2" value="98.8" lower_limit="96.6" upper_limit="99.8"/>
                    <measurement group_id="O3" value="98.8" lower_limit="96.6" upper_limit="99.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 200 mIU/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.6" lower_limit="97.7" upper_limit="100"/>
                    <measurement group_id="O2" value="98.4" lower_limit="96.1" upper_limit="99.6"/>
                    <measurement group_id="O3" value="98.4" lower_limit="96.1" upper_limit="99.6"/>
                  </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 (by ELISA)</title>
        <description>For mumps virus, a seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 10 EU/mL (ELISA) among subjects who were seronegative (antibody concentration &lt; 5 EU/mL) before dose 1.</description>
        <time_frame>At Day 84</time_frame>
        <population>ATP cohort for analysis of immunogenicity post dose 2: all eligible subjects from US sub-cohort who received 2 doses of Inv_MMR/Com_MMR vaccine, with pre- &amp; post-dose 2 serology results for at least 1 vaccine antigen for MMR, did not meet elimination criteria up to Day 84 blood sample &amp; complied with post-dose 2 blood sample schedule.</population>
        <group_list>
          <group group_id="O1">
            <title>Inv_MMR_Min Group</title>
            <description>Subjects received one dose of Inv_MMR, from a minimum potency lot (Inv_MMR_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O2">
            <title>Inv_MMR_Med Group</title>
            <description>Subjects received one dose of Inv_MMR, from a mid-range or medium potency lot (Inv_MMR_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O3">
            <title>Com_MMR Group</title>
            <description>Subjects received one dose of Com_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA)</title>
          <description>For mumps virus, a seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 10 EU/mL (ELISA) among subjects who were seronegative (antibody concentration &lt; 5 EU/mL) before dose 1.</description>
          <population>ATP cohort for analysis of immunogenicity post dose 2: all eligible subjects from US sub-cohort who received 2 doses of Inv_MMR/Com_MMR vaccine, with pre- &amp; post-dose 2 serology results for at least 1 vaccine antigen for MMR, did not meet elimination criteria up to Day 84 blood sample &amp; complied with post-dose 2 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="216"/>
                <count group_id="O2" value="199"/>
                <count group_id="O3" value="212"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>≥ 5 EU/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.1" lower_limit="96.7" upper_limit="99.9"/>
                    <measurement group_id="O2" value="100" lower_limit="98.2" upper_limit="100"/>
                    <measurement group_id="O3" value="99.1" lower_limit="96.6" 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="99.1" lower_limit="96.7" upper_limit="99.9"/>
                    <measurement group_id="O2" value="100" lower_limit="98.2" upper_limit="100"/>
                    <measurement group_id="O3" value="98.6" lower_limit="95.9" upper_limit="99.7"/>
                  </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 (by ELISA)</title>
        <description>For rubella virus, a seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥ 10 IU/mL (ELISA) among subjects who were seronegative (antibody concentration &lt; 4 IU/mL) before dose 1.</description>
        <time_frame>At Day 84</time_frame>
        <population>ATP cohort for analysis of immunogenicity post dose 2: all eligible subjects from US sub-cohort who received 2 doses of Inv_MMR/Com_MMR vaccine, with pre- &amp; post-dose 2 serology results for at least 1 vaccine antigen for MMR, did not meet elimination criteria up to Day 84 blood sample &amp; complied with post-dose 2 blood sample schedule.</population>
        <group_list>
          <group group_id="O1">
            <title>Inv_MMR_Min Group</title>
            <description>Subjects received one dose of Inv_MMR, from a minimum potency lot (Inv_MMR_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O2">
            <title>Inv_MMR_Med Group</title>
            <description>Subjects received one dose of Inv_MMR, from a mid-range or medium potency lot (Inv_MMR_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O3">
            <title>Com_MMR Group</title>
            <description>Subjects received one dose of Com_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA)</title>
          <description>For rubella virus, a seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥ 10 IU/mL (ELISA) among subjects who were seronegative (antibody concentration &lt; 4 IU/mL) before dose 1.</description>
          <population>ATP cohort for analysis of immunogenicity post dose 2: all eligible subjects from US sub-cohort who received 2 doses of Inv_MMR/Com_MMR vaccine, with pre- &amp; post-dose 2 serology results for at least 1 vaccine antigen for MMR, did not meet elimination criteria up to Day 84 blood sample &amp; complied with post-dose 2 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="245"/>
                <count group_id="O2" value="259"/>
                <count group_id="O3" value="255"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>≥ 4 IU/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="98.5" upper_limit="100"/>
                    <measurement group_id="O2" value="100" lower_limit="98.6" upper_limit="100"/>
                    <measurement group_id="O3" value="100" lower_limit="98.6" 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="99.6" lower_limit="97.7" upper_limit="100"/>
                    <measurement group_id="O2" value="99.6" lower_limit="97.9" upper_limit="100"/>
                    <measurement group_id="O3" value="99.6" lower_limit="97.8" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anti-measles Virus Antibody Concentrations (by ELISA)</title>
        <description>Antibody concentrations were expressed as GMCs in mIU/mL.</description>
        <time_frame>At Day 84</time_frame>
        <population>ATP cohort for analysis of immunogenicity post dose 2: all eligible subjects from US sub-cohort who received 2 doses of Inv_MMR/Com_MMR vaccine, with pre- &amp; post-dose 2 serology results for at least 1 vaccine antigen for MMR, did not meet elimination criteria up to Day 84 blood sample &amp; complied with post-dose 2 blood sample schedule.</population>
        <group_list>
          <group group_id="O1">
            <title>Inv_MMR_Min Group</title>
            <description>Subjects received one dose of Inv_MMR, from a minimum potency lot (Inv_MMR_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O2">
            <title>Inv_MMR_Med Group</title>
            <description>Subjects received one dose of Inv_MMR, from a mid-range or medium potency lot (Inv_MMR_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O3">
            <title>Com_MMR Group</title>
            <description>Subjects received one dose of Com_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
        </group_list>
        <measure>
          <title>Anti-measles Virus Antibody Concentrations (by ELISA)</title>
          <description>Antibody concentrations were expressed as GMCs in mIU/mL.</description>
          <population>ATP cohort for analysis of immunogenicity post dose 2: all eligible subjects from US sub-cohort who received 2 doses of Inv_MMR/Com_MMR vaccine, with pre- &amp; post-dose 2 serology results for at least 1 vaccine antigen for MMR, did not meet elimination criteria up to Day 84 blood sample &amp; complied with post-dose 2 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="245"/>
                <count group_id="O2" value="258"/>
                <count group_id="O3" value="257"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4803.5" lower_limit="4290.4" upper_limit="5378.0"/>
                    <measurement group_id="O2" value="4557.7" lower_limit="4061.5" upper_limit="5114.4"/>
                    <measurement group_id="O3" value="4453.9" lower_limit="3951.9" upper_limit="5019.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anti-mumps Virus Antibody Concentrations (by ELISA)</title>
        <description>Antibody concentrations were expressed as GMCs in EU/mL.</description>
        <time_frame>At Day 84</time_frame>
        <population>ATP cohort for analysis of immunogenicity post dose 2: all eligible subjects from US sub-cohort who received 2 doses of Inv_MMR/Com_MMR vaccine, with pre- &amp; post-dose 2 serology results for at least 1 vaccine antigen for MMR, did not meet elimination criteria up to Day 84 blood sample &amp; complied with post-dose 2 blood sample schedule.</population>
        <group_list>
          <group group_id="O1">
            <title>Inv_MMR_Min Group</title>
            <description>Subjects received one dose of Inv_MMR, from a minimum potency lot (Inv_MMR_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O2">
            <title>Inv_MMR_Med Group</title>
            <description>Subjects received one dose of Inv_MMR, from a mid-range or medium potency lot (Inv_MMR_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O3">
            <title>Com_MMR Group</title>
            <description>Subjects received one dose of Com_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
        </group_list>
        <measure>
          <title>Anti-mumps Virus Antibody Concentrations (by ELISA)</title>
          <description>Antibody concentrations were expressed as GMCs in EU/mL.</description>
          <population>ATP cohort for analysis of immunogenicity post dose 2: all eligible subjects from US sub-cohort who received 2 doses of Inv_MMR/Com_MMR vaccine, with pre- &amp; post-dose 2 serology results for at least 1 vaccine antigen for MMR, did not meet elimination criteria up to Day 84 blood sample &amp; complied with post-dose 2 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="216"/>
                <count group_id="O2" value="199"/>
                <count group_id="O3" value="212"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.9" lower_limit="80.4" upper_limit="98.3"/>
                    <measurement group_id="O2" value="94.1" lower_limit="85.3" upper_limit="103.8"/>
                    <measurement group_id="O3" value="86.4" lower_limit="77.4" upper_limit="96.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anti-rubella Virus Antibody Concentrations (by ELISA)</title>
        <description>Antibody concentrations were expressed as GMCs in IU/mL.</description>
        <time_frame>At Day 84</time_frame>
        <population>ATP cohort for analysis of immunogenicity post dose 2: all eligible subjects from US sub-cohort who received 2 doses of Inv_MMR/Com_MMR vaccine, with pre- &amp; post-dose 2 serology results for at least 1 vaccine antigen for MMR, did not meet elimination criteria up to Day 84 blood sample &amp; complied with post-dose 2 blood sample schedule.</population>
        <group_list>
          <group group_id="O1">
            <title>Inv_MMR_Min Group</title>
            <description>Subjects received one dose of Inv_MMR, from a minimum potency lot (Inv_MMR_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O2">
            <title>Inv_MMR_Med Group</title>
            <description>Subjects received one dose of Inv_MMR, from a mid-range or medium potency lot (Inv_MMR_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O3">
            <title>Com_MMR Group</title>
            <description>Subjects received one dose of Com_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
        </group_list>
        <measure>
          <title>Anti-rubella Virus Antibody Concentrations (by ELISA)</title>
          <description>Antibody concentrations were expressed as GMCs in IU/mL.</description>
          <population>ATP cohort for analysis of immunogenicity post dose 2: all eligible subjects from US sub-cohort who received 2 doses of Inv_MMR/Com_MMR vaccine, with pre- &amp; post-dose 2 serology results for at least 1 vaccine antigen for MMR, did not meet elimination criteria up to Day 84 blood sample &amp; complied with post-dose 2 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="245"/>
                <count group_id="O2" value="259"/>
                <count group_id="O3" value="255"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="112.7" lower_limit="104.1" upper_limit="122.0"/>
                    <measurement group_id="O2" value="110.7" lower_limit="102.9" upper_limit="119.1"/>
                    <measurement group_id="O3" value="110.9" lower_limit="101.8" upper_limit="120.8"/>
                  </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) Post Dose 1</title>
        <description>Assessed solicited local AEs were pain, redness and swelling. Any = Occurrence of the 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>Total Vaccinated cohort (TVC) included all vaccinated subjects with at least one vaccine administration of either Inv_MMR lots or Com_MMR lots documented.</population>
        <group_list>
          <group group_id="O1">
            <title>Inv_MMR_Min Group</title>
            <description>Subjects received one dose of Inv_MMR, from a minimum potency lot (Inv_MMR_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O2">
            <title>Inv_MMR_Med Group</title>
            <description>Subjects received one dose of Inv_MMR, from a mid-range or medium potency lot (Inv_MMR_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O3">
            <title>Com_MMR Group</title>
            <description>Subjects received one dose of Com_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Any Solicited Local Adverse Events (AEs) Post Dose 1</title>
          <description>Assessed solicited local AEs were pain, redness and swelling. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.</description>
          <population>Total Vaccinated cohort (TVC) included all vaccinated subjects with at least one vaccine administration of either Inv_MMR lots or Com_MMR 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="1453"/>
                <count group_id="O2" value="1464"/>
                <count group_id="O3" value="1482"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="261"/>
                    <measurement group_id="O2" value="262"/>
                    <measurement group_id="O3" value="301"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any redness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="232"/>
                    <measurement group_id="O2" value="256"/>
                    <measurement group_id="O3" value="286"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any swelling</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89"/>
                    <measurement group_id="O2" value="97"/>
                    <measurement group_id="O3" value="122"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Any Solicited Local AEs Post Dose 2</title>
        <description>Assessed solicited local AEs were pain, redness and swelling. Any = Occurrence of the 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>TVC included all vaccinated subjects with at least one vaccine administration of either Inv_MMR lots or Com_MMR lots documented.</population>
        <group_list>
          <group group_id="O1">
            <title>Inv_MMR_Min Group</title>
            <description>Subjects received one dose of Inv_MMR, from a minimum potency lot (Inv_MMR_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O2">
            <title>Inv_MMR_Med Group</title>
            <description>Subjects received one dose of Inv_MMR, from a mid-range or medium potency lot (Inv_MMR_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O3">
            <title>Com_MMR Group</title>
            <description>Subjects received one dose of Com_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Any Solicited Local AEs Post Dose 2</title>
          <description>Assessed solicited local AEs were pain, redness and swelling. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.</description>
          <population>TVC included all vaccinated subjects with at least one vaccine administration of either Inv_MMR lots or Com_MMR 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="1427"/>
                <count group_id="O2" value="1440"/>
                <count group_id="O3" value="1456"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="170"/>
                    <measurement group_id="O2" value="183"/>
                    <measurement group_id="O3" value="196"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any redness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="159"/>
                    <measurement group_id="O2" value="196"/>
                    <measurement group_id="O3" value="217"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any swelling</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67"/>
                    <measurement group_id="O2" value="91"/>
                    <measurement group_id="O3" value="96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Any Solicited General AEs Post Dose 1</title>
        <description>Assessed solicited general AEs were drowsiness, irritability/fussiness and loss of appetite. Any = Occurrence of the 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>TVC included all vaccinated subjects with at least one vaccine administration of either Inv_MMR lots or Com_MMR lots documented.</population>
        <group_list>
          <group group_id="O1">
            <title>Inv_MMR_Min Group</title>
            <description>Subjects received one dose of Inv_MMR, from a minimum potency lot (Inv_MMR_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O2">
            <title>Inv_MMR_Med Group</title>
            <description>Subjects received one dose of Inv_MMR, from a mid-range or medium potency lot (Inv_MMR_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O3">
            <title>Com_MMR Group</title>
            <description>Subjects received one dose of Com_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Any Solicited General AEs Post Dose 1</title>
          <description>Assessed solicited general AEs were drowsiness, irritability/fussiness and loss of appetite. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.</description>
          <population>TVC included all vaccinated subjects with at least one vaccine administration of either Inv_MMR lots or Com_MMR 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="1454"/>
                <count group_id="O2" value="1466"/>
                <count group_id="O3" value="1486"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any drowsiness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="551"/>
                    <measurement group_id="O2" value="565"/>
                    <measurement group_id="O3" value="582"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any irritability / fussiness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="749"/>
                    <measurement group_id="O2" value="792"/>
                    <measurement group_id="O3" value="788"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any loss of appetite</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="570"/>
                    <measurement group_id="O2" value="589"/>
                    <measurement group_id="O3" value="591"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting Any Fever Post Dose 1</title>
        <description>Any fever = Fever (axillary) ≥ 38°C.</description>
        <time_frame>During the 43-day (Days 0-42) post-vaccination period</time_frame>
        <population>TVC included all vaccinated subjects with at least one vaccine administration of either Inv_MMR lots or Com_MMR lots documented.</population>
        <group_list>
          <group group_id="O1">
            <title>Inv_MMR_Min Group</title>
            <description>Subjects received one dose of Inv_MMR, from a minimum potency lot (Inv_MMR_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O2">
            <title>Inv_MMR_Med Group</title>
            <description>Subjects received one dose of Inv_MMR, from a mid-range or medium potency lot (Inv_MMR_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O3">
            <title>Com_MMR Group</title>
            <description>Subjects received one dose of Com_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Any Fever Post Dose 1</title>
          <description>Any fever = Fever (axillary) ≥ 38°C.</description>
          <population>TVC included all vaccinated subjects with at least one vaccine administration of either Inv_MMR lots or Com_MMR 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="1454"/>
                <count group_id="O2" value="1466"/>
                <count group_id="O3" value="1486"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="582"/>
                    <measurement group_id="O2" value="617"/>
                    <measurement group_id="O3" value="618"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting Any Fever Post Dose 2</title>
        <description>Any fever = Fever (axillary) ≥ 38°C.</description>
        <time_frame>During the 43-day (Days 0-42) post-vaccination period</time_frame>
        <population>TVC included all vaccinated subjects with at least one vaccine administration of either Inv_MMR lots or Com_MMR lots documented.</population>
        <group_list>
          <group group_id="O1">
            <title>Inv_MMR_Min Group</title>
            <description>Subjects received one dose of Inv_MMR, from a minimum potency lot (Inv_MMR_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O2">
            <title>Inv_MMR_Med Group</title>
            <description>Subjects received one dose of Inv_MMR, from a mid-range or medium potency lot (Inv_MMR_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O3">
            <title>Com_MMR Group</title>
            <description>Subjects received one dose of Com_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Any Fever Post Dose 2</title>
          <description>Any fever = Fever (axillary) ≥ 38°C.</description>
          <population>TVC included all vaccinated subjects with at least one vaccine administration of either Inv_MMR lots or Com_MMR 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="1426"/>
                <count group_id="O2" value="1443"/>
                <count group_id="O3" value="1455"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="458"/>
                    <measurement group_id="O2" value="471"/>
                    <measurement group_id="O3" value="499"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting Any Rash Post Dose 1</title>
        <description>Assessed were any localized or generalized rash, rash with fever, varicella-like rash and measles/rubella-like rash. Any = Occurrence of the 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>TVC included all vaccinated subjects with at least one vaccine administration of either Inv_MMR lots or Com_MMR lots documented.</population>
        <group_list>
          <group group_id="O1">
            <title>Inv_MMR_Min Group</title>
            <description>Subjects received one dose of Inv_MMR, from a minimum potency lot (Inv_MMR_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O2">
            <title>Inv_MMR_Med Group</title>
            <description>Subjects received one dose of Inv_MMR, from a mid-range or medium potency lot (Inv_MMR_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O3">
            <title>Com_MMR Group</title>
            <description>Subjects received one dose of Com_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Any Rash Post Dose 1</title>
          <description>Assessed were any localized or generalized rash, rash with fever, varicella-like rash and measles/rubella-like rash. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.</description>
          <population>TVC included all vaccinated subjects with at least one vaccine administration of either Inv_MMR lots or Com_MMR 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="1454"/>
                <count group_id="O2" value="1466"/>
                <count group_id="O3" value="1486"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any localized or generalized</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="328"/>
                    <measurement group_id="O2" value="322"/>
                    <measurement group_id="O3" value="333"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any with fever</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="115"/>
                    <measurement group_id="O2" value="133"/>
                    <measurement group_id="O3" value="131"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any varicella like</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57"/>
                    <measurement group_id="O2" value="53"/>
                    <measurement group_id="O3" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any measles/rubella like</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53"/>
                    <measurement group_id="O2" value="61"/>
                    <measurement group_id="O3" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting Any Rash Post Dose 2</title>
        <description>Assessed were any localized or generalized rash, rash with fever, varicella-like rash and measles/rubella-like rash. Any = Occurrence of the 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>TVC included all vaccinated subjects with at least one vaccine administration of either Inv_MMR lots or Com_MMR lots documented.</population>
        <group_list>
          <group group_id="O1">
            <title>Inv_MMR_Min Group</title>
            <description>Subjects received one dose of Inv_MMR, from a minimum potency lot (Inv_MMR_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O2">
            <title>Inv_MMR_Med Group</title>
            <description>Subjects received one dose of Inv_MMR, from a mid-range or medium potency lot (Inv_MMR_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O3">
            <title>Com_MMR Group</title>
            <description>Subjects received one dose of Com_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Any Rash Post Dose 2</title>
          <description>Assessed were any localized or generalized rash, rash with fever, varicella-like rash and measles/rubella-like rash. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.</description>
          <population>TVC included all vaccinated subjects with at least one vaccine administration of either Inv_MMR lots or Com_MMR 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="1426"/>
                <count group_id="O2" value="1443"/>
                <count group_id="O3" value="1455"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any localized or generalized</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="129"/>
                    <measurement group_id="O2" value="150"/>
                    <measurement group_id="O3" value="141"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any with fever</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52"/>
                    <measurement group_id="O2" value="63"/>
                    <measurement group_id="O3" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any varicella like</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any measles/rubella like</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="14"/>
                    <measurement group_id="O3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting Any MMR Specific Solicited General AEs Post Dose 1</title>
        <description>Assessed MMR specific solicited general AEs were any suspected signs of meningism including febrile convulsions and parotid/salivary gland swelling. Any = Occurrence of the 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>TVC included all vaccinated subjects with at least one vaccine administration of either Inv_MMR lots or Com_MMR lots documented.</population>
        <group_list>
          <group group_id="O1">
            <title>Inv_MMR_Min Group</title>
            <description>Subjects received one dose of Inv_MMR, from a minimum potency lot (Inv_MMR_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O2">
            <title>Inv_MMR_Med Group</title>
            <description>Subjects received one dose of Inv_MMR, from a mid-range or medium potency lot (Inv_MMR_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O3">
            <title>Com_MMR Group</title>
            <description>Subjects received one dose of Com_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Any MMR Specific Solicited General AEs Post Dose 1</title>
          <description>Assessed MMR specific solicited general AEs were any suspected signs of meningism including febrile convulsions and parotid/salivary gland swelling. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.</description>
          <population>TVC included all vaccinated subjects with at least one vaccine administration of either Inv_MMR lots or Com_MMR 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="1454"/>
                <count group_id="O2" value="1466"/>
                <count group_id="O3" value="1486"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any parotid gland swelling</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any febrile convulsion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting Any MMR Specific Solicited General AEs Post Dose 2</title>
        <description>Assessed MMR specific solicited general AEs were any suspected signs of meningism including febrile convulsions and parotid/salivary gland swelling. Any = Occurrence of the 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>TVC included all vaccinated subjects with at least one vaccine administration of either Inv_MMR lots or Com_MMR lots documented.</population>
        <group_list>
          <group group_id="O1">
            <title>Inv_MMR_Min Group</title>
            <description>Subjects received one dose of Inv_MMR, from a minimum potency lot (Inv_MMR_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O2">
            <title>Inv_MMR_Med Group</title>
            <description>Subjects received one dose of Inv_MMR, from a mid-range or medium potency lot (Inv_MMR_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O3">
            <title>Com_MMR Group</title>
            <description>Subjects received one dose of Com_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Any MMR Specific Solicited General AEs Post Dose 2</title>
          <description>Assessed MMR specific solicited general AEs were any suspected signs of meningism including febrile convulsions and parotid/salivary gland swelling. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.</description>
          <population>TVC included all vaccinated subjects with at least one vaccine administration of either Inv_MMR lots or Com_MMR 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="1426"/>
                <count group_id="O2" value="1443"/>
                <count group_id="O3" value="1455"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any parotid gland swelling</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" 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="6"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting Any Unsolicited AES Post Dose 1</title>
        <description>Unsolicited AE was defined as any AE reported in 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 the 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>TVC included all vaccinated subjects with at least one vaccine administration of either Inv_MMR lots or Com_MMR lots documented.</population>
        <group_list>
          <group group_id="O1">
            <title>Inv_MMR_Min Group</title>
            <description>Subjects received one dose of Inv_MMR, from a minimum potency lot (Inv_MMR_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O2">
            <title>Inv_MMR_Med Group</title>
            <description>Subjects received one dose of Inv_MMR, from a mid-range or medium potency lot (Inv_MMR_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O3">
            <title>Com_MMR Group</title>
            <description>Subjects received one dose of Com_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Any Unsolicited AES Post Dose 1</title>
          <description>Unsolicited AE was defined as any AE reported in 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 the AE regardless of intensity grade or relation to vaccination.</description>
          <population>TVC included all vaccinated subjects with at least one vaccine administration of either Inv_MMR lots or Com_MMR 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="1493"/>
                <count group_id="O2" value="1497"/>
                <count group_id="O3" value="1526"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="762"/>
                    <measurement group_id="O2" value="794"/>
                    <measurement group_id="O3" value="777"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting Any Unsolicited AES Post Dose 2</title>
        <description>Unsolicited AE was defined as any AE reported in 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 the 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>TVC included all vaccinated subjects with at least one vaccine administration of either Inv_MMR lots or Com_MMR lots documented.</population>
        <group_list>
          <group group_id="O1">
            <title>Inv_MMR_Min Group</title>
            <description>Subjects received one dose of Inv_MMR, from a minimum potency lot (Inv_MMR_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O2">
            <title>Inv_MMR_Med Group</title>
            <description>Subjects received one dose of Inv_MMR, from a mid-range or medium potency lot (Inv_MMR_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O3">
            <title>Com_MMR Group</title>
            <description>Subjects received one dose of Com_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Any Unsolicited AES Post Dose 2</title>
          <description>Unsolicited AE was defined as any AE reported in 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 the AE regardless of intensity grade or relation to vaccination.</description>
          <population>TVC included all vaccinated subjects with at least one vaccine administration of either Inv_MMR lots or Com_MMR 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="1449"/>
                <count group_id="O2" value="1464"/>
                <count group_id="O3" value="1483"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="667"/>
                    <measurement group_id="O2" value="703"/>
                    <measurement group_id="O3" value="690"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting Any 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>From Day 0 through the end of the study (Day 222)</time_frame>
        <population>TVC included all vaccinated subjects with at least one vaccine administration of either Inv_MMR lots or Com_MMR lots documented.</population>
        <group_list>
          <group group_id="O1">
            <title>Inv_MMR_Min Group</title>
            <description>Subjects received one dose of Inv_MMR, from a minimum potency lot (Inv_MMR_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O2">
            <title>Inv_MMR_Med Group</title>
            <description>Subjects received one dose of Inv_MMR, from a mid-range or medium potency lot (Inv_MMR_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O3">
            <title>Com_MMR Group</title>
            <description>Subjects received one dose of Com_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Any 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>TVC included all vaccinated subjects with at least one vaccine administration of either Inv_MMR lots or Com_MMR 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="1493"/>
                <count group_id="O2" value="1497"/>
                <count group_id="O3" value="1526"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any NOCD</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="39"/>
                    <measurement group_id="O3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any AE prompting ER visit</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="348"/>
                    <measurement group_id="O2" value="361"/>
                    <measurement group_id="O3" value="347"/>
                  </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>SAEs assessed include any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization or resulted in disability/incapacity.</description>
        <time_frame>From Day 0 through the end of the study (Day 222)</time_frame>
        <population>TVC included all vaccinated subjects with at least one vaccine administration of either Inv_MMR lots or Com_MMR lots documented.</population>
        <group_list>
          <group group_id="O1">
            <title>Inv_MMR_Min Group</title>
            <description>Subjects received one dose of Inv_MMR, from a minimum potency lot (Inv_MMR_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O2">
            <title>Inv_MMR_Med Group</title>
            <description>Subjects received one dose of Inv_MMR, from a mid-range or medium potency lot (Inv_MMR_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O3">
            <title>Com_MMR Group</title>
            <description>Subjects received one dose of Com_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Any Serious Adverse Events (SAEs)</title>
          <description>SAEs assessed include any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization or resulted in disability/incapacity.</description>
          <population>TVC included all vaccinated subjects with at least one vaccine administration of either Inv_MMR lots or Com_MMR 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="1493"/>
                <count group_id="O2" value="1497"/>
                <count group_id="O3" value="1526"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91"/>
                    <measurement group_id="O2" value="102"/>
                    <measurement group_id="O3" value="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Solicited local &amp; general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Inv_MMR_Min Group</title>
          <description>Subjects received one dose of Inv_MMR, from a minimum potency lot (Inv_MMR_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
        </group>
        <group group_id="E2">
          <title>Inv_MMR_Med Group</title>
          <description>Subjects received one dose of Inv_MMR, from a mid-range or medium potency lot (Inv_MMR_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
        </group>
        <group group_id="E3">
          <title>Com_MMR Group</title>
          <description>Subjects received one dose of Com_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</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="1" subjects_at_risk="1493"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="91" subjects_at_risk="1493"/>
                <counts group_id="E2" subjects_affected="102" subjects_at_risk="1497"/>
                <counts group_id="E3" subjects_affected="92" subjects_at_risk="1526"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Haemolytic anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Hypochromic anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Iron deficiency anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="1497"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Anal fistula</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="1497"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Food poisoning</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Intestinal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Perianal erythema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Teething</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Drowning</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Liver disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Allergy to arthropod bite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Adenovirus infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Anal abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Atypical pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Bronchiolitis</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="1493"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="1497"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="1493"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="1497"/>
                <counts group_id="E3" events="8" subjects_affected="8" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Bronchitis viral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Campylobacter gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1497"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Cellulitis orbital</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Croup infectious</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1493"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="1497"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Cystitis klebsiella</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Dengue fever</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Diarrhoea infectious</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Empyema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Encephalitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Encephalitis brain stem</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Enterococcal bacteraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Escherichia urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Exanthema subitum</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="16" subjects_affected="16" subjects_at_risk="1493"/>
                <counts group_id="E2" events="19" subjects_affected="19" subjects_at_risk="1497"/>
                <counts group_id="E3" events="10" subjects_affected="10" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Gastroenteritis bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Gastroenteritis rotavirus</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="1493"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="1497"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Gastroenteritis salmonella</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Hand-foot-and-mouth disease</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1493"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1497"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Herpangina</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="1493"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1497"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Laryngitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Laryngotracheitis obstructive</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Meningitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Nail bed infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1493"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Nosocomial infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="1493"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="1497"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Otitis media acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Otitis media viral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Otosalpingitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Periorbital cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="1493"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Pharyngotonsillitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1493"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="1493"/>
                <counts group_id="E2" events="14" subjects_affected="14" subjects_at_risk="1497"/>
                <counts group_id="E3" events="10" subjects_affected="10" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Pneumonia bacterial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Pneumonia respiratory syncytial viral</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Pneumonia viral</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1493"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Pyelonephritis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Respiratory syncytial virus bronchiolitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Respiratory syncytial virus bronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Respiratory syncytial virus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Skin candida</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Staphylococcal bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Staphylococcal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Subcutaneous abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1493"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="1497"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Viral pharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Viral tonsillitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Accidental poisoning</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Burns second degree</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Chest injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Child maltreatment syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Concussion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Face injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Foreign body</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Head injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Joint dislocation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Limb crushing injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Mouth injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Multiple injuries</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Poisoning</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Thermal burn</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Toxicity to various agents</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="1493"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="1497"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Electrolyte imbalance</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Metabolic acidosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Type 1 diabetes mellitus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Juvenile idiopathic arthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Synovitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Burning sensation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Febrile convulsion</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="1493"/>
                <counts group_id="E2" events="15" subjects_affected="13" subjects_at_risk="1497"/>
                <counts group_id="E3" events="8" subjects_affected="8" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Intracranial pressure increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Apnoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Aspiration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Atelectasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Bronchial hyperreactivity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Bronchospasm</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Respiratory distress</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Angioedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Henoch-schonlein purpura</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Petechiae</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Stevens-johnson syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Toxic skin eruption</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Circulatory collapse</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Phlebitis superficial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Thrombophlebitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="1299" subjects_at_risk="1493"/>
                <counts group_id="E2" subjects_affected="1311" subjects_at_risk="1497"/>
                <counts group_id="E3" subjects_affected="1330" subjects_at_risk="1526"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="1493"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="1497"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Hypochromic anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Iron deficiency anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Lymphadenitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1493"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1497"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="1493"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="1497"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Thrombocytosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Dermoid cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Inborn error of metabolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Keratosis follicular</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Naevus flammeus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Phimosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Talipes</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Cerumen impaction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Ear disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="1493"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="1497"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Middle ear inflammation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Otorrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Tympanic membrane perforation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1526"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Blepharitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Conjunctival hyperaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Conjunctivitis allergic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Eye discharge</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1497"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Eye oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Eye swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Eyelid bleeding</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Eyelid cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Eyelid oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Keratitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Lacrimation increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Ocular hyperaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="1493"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="1497"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Anal fissure</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="1493"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="1497"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Aphthous ulcer</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="1493"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="1497"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Cheilitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="1493"/>
                <counts group_id="E2" events="13" subjects_affected="11" subjects_at_risk="1497"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="83" subjects_affected="73" subjects_at_risk="1493"/>
                <counts group_id="E2" events="76" subjects_affected="71" subjects_at_risk="1497"/>
                <counts group_id="E3" events="80" subjects_affected="75" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Enteritis</sub_title>
                <counts group_id="E1" events="19" subjects_affected="19" subjects_at_risk="1493"/>
                <counts group_id="E2" events="23" subjects_affected="21" subjects_at_risk="1497"/>
                <counts group_id="E3" events="20" subjects_affected="19" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Enterocolitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Faeces discoloured</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Food poisoning</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Functional gastrointestinal disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1493"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1497"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Gingival disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Gingival pain</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="1493"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="1497"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Glossodynia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Lip disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Lip ulceration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Malocclusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Mouth ulceration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1497"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Noninfective gingivitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Oral disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Palatal ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Periodontal disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Protein-losing gastroenteropathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Regurgitation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Salivary gland enlargement</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Salivary hypersecretion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="1493"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="1497"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Teething</sub_title>
                <counts group_id="E1" events="86" subjects_affected="62" subjects_at_risk="1493"/>
                <counts group_id="E2" events="104" subjects_affected="71" subjects_at_risk="1497"/>
                <counts group_id="E3" events="82" subjects_affected="64" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Tongue blistering</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Tooth discolouration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Tooth disorder</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="1493"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" events="31" subjects_affected="22" subjects_at_risk="1493"/>
                <counts group_id="E2" events="21" subjects_affected="17" subjects_at_risk="1497"/>
                <counts group_id="E3" events="22" subjects_affected="17" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="55" subjects_affected="43" subjects_at_risk="1493"/>
                <counts group_id="E2" events="45" subjects_affected="42" subjects_at_risk="1497"/>
                <counts group_id="E3" events="51" subjects_affected="48" subjects_at_risk="1526"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Adverse drug reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Application site erythema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Application site hypersensitivity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Crying</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="1493"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="1497"/>
                <counts group_id="E3" events="7" subjects_affected="5" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Decreased activity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1493"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Feeling hot</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Gait disturbance</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Injection site bruising</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="1493"/>
                <counts group_id="E2" events="15" subjects_affected="15" subjects_at_risk="1497"/>
                <counts group_id="E3" events="9" subjects_affected="9" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Injection site haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Injection site haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Injection site induration</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1493"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="1497"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Injection site inflammation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Injection site mass</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Injection site nodule</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Injection site papule</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Injection site swelling</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="1493"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="1497"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Injection site urticaria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Local swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="1493"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="1497"/>
                <counts group_id="E3" events="4" subjects_affected="2" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Mass</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="431" subjects_affected="334" subjects_at_risk="1493"/>
                <counts group_id="E2" events="445" subjects_affected="336" subjects_at_risk="1497"/>
                <counts group_id="E3" events="500" subjects_affected="378" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Swelling</sub_title>
                <counts group_id="E1" events="156" subjects_affected="123" subjects_at_risk="1493"/>
                <counts group_id="E2" events="188" subjects_affected="152" subjects_at_risk="1497"/>
                <counts group_id="E3" events="218" subjects_affected="170" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Vaccination site erythema</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="1493"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="1497"/>
                <counts group_id="E3" events="8" subjects_affected="8" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Vaccination site haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Vaccination site pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Vaccination site rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Vaccination site reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Vaccination site swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Vessel puncture site haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Allergy to animal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Drug hypersensitivity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1497"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Food allergy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Milk allergy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Multiple allergies</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Acarodermatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Acute sinusitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Adenoiditis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Adenoviral conjunctivitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Adenovirus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Angular cheilitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Body tinea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Bronchiolitis</sub_title>
                <counts group_id="E1" events="22" subjects_affected="18" subjects_at_risk="1493"/>
                <counts group_id="E2" events="22" subjects_affected="22" subjects_at_risk="1497"/>
                <counts group_id="E3" events="22" subjects_affected="21" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="92" subjects_affected="81" subjects_at_risk="1493"/>
                <counts group_id="E2" events="115" subjects_affected="96" subjects_at_risk="1497"/>
                <counts group_id="E3" events="95" subjects_affected="77" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Bronchitis viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Bullous impetigo</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Burn infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Campylobacter gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1497"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Campylobacter infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Candida infection</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="1493"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="1497"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Candida nappy rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1497"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" events="67" subjects_affected="63" subjects_at_risk="1493"/>
                <counts group_id="E2" events="90" subjects_affected="79" subjects_at_risk="1497"/>
                <counts group_id="E3" events="87" subjects_affected="79" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Conjunctivitis bacterial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Conjunctivitis viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Coxsackie viral infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Croup infectious</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="1493"/>
                <counts group_id="E2" events="11" subjects_affected="11" subjects_at_risk="1497"/>
                <counts group_id="E3" events="13" subjects_affected="12" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Cryptosporidiosis infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" events="19" subjects_affected="19" subjects_at_risk="1493"/>
                <counts group_id="E2" events="20" subjects_affected="19" subjects_at_risk="1497"/>
                <counts group_id="E3" events="13" subjects_affected="12" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Eczema impetiginous</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Enterobiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Enterovirus infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Erythema infectiosum</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Exanthema subitum</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1493"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Eye infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Fungal infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Fungal skin infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Furuncle</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Gastritis viral</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="93" subjects_affected="88" subjects_at_risk="1493"/>
                <counts group_id="E2" events="107" subjects_affected="95" subjects_at_risk="1497"/>
                <counts group_id="E3" events="100" subjects_affected="93" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Gastroenteritis norovirus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Gastroenteritis salmonella</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="1493"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="1497"/>
                <counts group_id="E3" events="9" subjects_affected="9" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Genital candidiasis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Gingivitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Hand-foot-and-mouth disease</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="1493"/>
                <counts group_id="E2" events="23" subjects_affected="23" subjects_at_risk="1497"/>
                <counts group_id="E3" events="11" subjects_affected="10" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Herpangina</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="1493"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="1497"/>
                <counts group_id="E3" events="8" subjects_affected="8" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Herpes virus infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Hordeolum</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="1493"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Impetigo</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="1493"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="1497"/>
                <counts group_id="E3" events="9" subjects_affected="9" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Infected bite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="1493"/>
                <counts group_id="E2" events="13" subjects_affected="11" subjects_at_risk="1497"/>
                <counts group_id="E3" events="10" subjects_affected="10" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Laryngitis</sub_title>
                <counts group_id="E1" events="35" subjects_affected="34" subjects_at_risk="1493"/>
                <counts group_id="E2" events="37" subjects_affected="34" subjects_at_risk="1497"/>
                <counts group_id="E3" events="30" subjects_affected="27" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Lice infestation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Localised infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="1493"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="1497"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection viral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Mastitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Molluscum contagiosum</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Mycoplasma infection</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="177" subjects_affected="148" subjects_at_risk="1493"/>
                <counts group_id="E2" events="210" subjects_affected="176" subjects_at_risk="1497"/>
                <counts group_id="E3" events="154" subjects_affected="134" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="8" subjects_affected="8" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Oral fungal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Orchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Otitis externa</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="1493"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="1497"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" events="120" subjects_affected="95" subjects_at_risk="1493"/>
                <counts group_id="E2" events="117" subjects_affected="99" subjects_at_risk="1497"/>
                <counts group_id="E3" events="143" subjects_affected="116" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Otitis media acute</sub_title>
                <counts group_id="E1" events="55" subjects_affected="46" subjects_at_risk="1493"/>
                <counts group_id="E2" events="60" subjects_affected="49" subjects_at_risk="1497"/>
                <counts group_id="E3" events="65" subjects_affected="57" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Parasitic gastroenteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Paronychia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Periorbital cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="61" subjects_affected="50" subjects_at_risk="1493"/>
                <counts group_id="E2" events="56" subjects_affected="53" subjects_at_risk="1497"/>
                <counts group_id="E3" events="57" subjects_affected="55" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Pharyngitis streptococcal</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Pharyngotonsillitis</sub_title>
                <counts group_id="E1" events="15" subjects_affected="14" subjects_at_risk="1493"/>
                <counts group_id="E2" events="16" subjects_affected="15" subjects_at_risk="1497"/>
                <counts group_id="E3" events="17" subjects_affected="17" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="1493"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="1497"/>
                <counts group_id="E3" events="9" subjects_affected="9" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Pneumonia mycoplasmal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Pneumonia viral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Pseudocroup</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Pyoderma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Respiratory syncytial virus bronchiolitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Respiratory syncytial virus infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="1497"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" events="25" subjects_affected="24" subjects_at_risk="1493"/>
                <counts group_id="E2" events="28" subjects_affected="24" subjects_at_risk="1497"/>
                <counts group_id="E3" events="30" subjects_affected="22" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection viral</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="1493"/>
                <counts group_id="E2" events="10" subjects_affected="9" subjects_at_risk="1497"/>
                <counts group_id="E3" events="11" subjects_affected="7" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" events="53" subjects_affected="37" subjects_at_risk="1493"/>
                <counts group_id="E2" events="56" subjects_affected="49" subjects_at_risk="1497"/>
                <counts group_id="E3" events="33" subjects_affected="30" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Rhinovirus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Roseola</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Salmonellosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Scarlet fever</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="12" subjects_affected="11" subjects_at_risk="1493"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="1497"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Sinusitis bacterial</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Skin bacterial infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Skin candida</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Staphylococcal abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Staphylococcal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Streptococcal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Subcutaneous abscess</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Superinfection bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" events="36" subjects_affected="34" subjects_at_risk="1493"/>
                <counts group_id="E2" events="27" subjects_affected="24" subjects_at_risk="1497"/>
                <counts group_id="E3" events="36" subjects_affected="34" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Tonsillitis bacterial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Tooth abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Tracheitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="1497"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Tracheobronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="475" subjects_affected="350" subjects_at_risk="1493"/>
                <counts group_id="E2" events="473" subjects_affected="354" subjects_at_risk="1497"/>
                <counts group_id="E3" events="485" subjects_affected="365" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection bacterial</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="1493"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="1497"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Varicella</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" events="50" subjects_affected="45" subjects_at_risk="1493"/>
                <counts group_id="E2" events="57" subjects_affected="51" subjects_at_risk="1497"/>
                <counts group_id="E3" events="61" subjects_affected="57" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Viral pharyngitis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="1493"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1497"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Viral rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Viral rhinitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Viral tonsillitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1493"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="1497"/>
                <counts group_id="E3" events="12" subjects_affected="11" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Vulvitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Vulvovaginitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Accidental exposure to product</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Animal bite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Arthropod bite</sub_title>
                <counts group_id="E1" events="29" subjects_affected="24" subjects_at_risk="1493"/>
                <counts group_id="E2" events="23" subjects_affected="21" subjects_at_risk="1497"/>
                <counts group_id="E3" events="13" subjects_affected="12" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Arthropod sting</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="1493"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Burns second degree</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="1493"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="1497"/>
                <counts group_id="E3" events="9" subjects_affected="9" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Ear canal abrasion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Excoriation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Exposure to communicable disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Exposure to toxic agent</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Eye injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Eyelid injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Face injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="1493"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="1497"/>
                <counts group_id="E3" events="8" subjects_affected="7" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Foot fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Foreign body</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Head injury</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="1493"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="1497"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Injury</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1493"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1497"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Joint dislocation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="1493"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="1497"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Lip injury</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1493"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Mouth injury</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Procedural vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Radial head dislocation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Radius fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Skin abrasion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1493"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="1497"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Skin wound</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Thermal burn</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1493"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="1497"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Tibia fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Tongue injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Tooth fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Tooth injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Vaccination complication</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="1497"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Wound</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="1493"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="1497"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="1526"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Body temperature increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Cardiac murmur</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Gastric ph decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Haemoglobin decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Staphylococcus test positive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </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="575" subjects_affected="571" subjects_at_risk="1493"/>
                <counts group_id="E2" events="595" subjects_affected="593" subjects_at_risk="1497"/>
                <counts group_id="E3" events="593" subjects_affected="593" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Disaccharide metabolism disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Failure to thrive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Feeding disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Hyposideraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Lactase deficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Lactose intolerance</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1526"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Foot deformity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Neck mass</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Synovitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Brain neoplasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Haemangioma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Melanocytic naevus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Pyogenic granuloma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Aphonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Drooling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Language disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Lethargy</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Poor quality sleep</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Psychomotor hyperactivity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Sleep phase rhythm disturbance</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="552" subjects_affected="551" subjects_at_risk="1493"/>
                <counts group_id="E2" events="569" subjects_affected="567" subjects_at_risk="1497"/>
                <counts group_id="E3" events="582" subjects_affected="582" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Tongue biting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Abortion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Perinatal brain damage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device occlusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Bruxism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" events="781" subjects_affected="757" subjects_at_risk="1493"/>
                <counts group_id="E2" events="815" subjects_affected="795" subjects_at_risk="1497"/>
                <counts group_id="E3" events="815" subjects_affected="793" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Mood altered</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Nervousness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Restlessness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Tearfulness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Balanoposthitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1493"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="1497"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Genital erythema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Genital labial adhesions</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Penile adhesion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Penile erythema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Perineal erythema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Scrotal swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Testicular pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="1497"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Bronchial hyperreactivity</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="1493"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="1497"/>
                <counts group_id="E3" events="9" subjects_affected="8" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Bronchospasm</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="1493"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="1497"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Catarrh</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1497"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="68" subjects_affected="59" subjects_at_risk="1493"/>
                <counts group_id="E2" events="74" subjects_affected="64" subjects_at_risk="1497"/>
                <counts group_id="E3" events="84" subjects_affected="75" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Dysphonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="1493"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="1497"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract congestion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="1493"/>
                <counts group_id="E2" events="12" subjects_affected="12" subjects_at_risk="1497"/>
                <counts group_id="E3" events="12" subjects_affected="10" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="1497"/>
                <counts group_id="E3" events="6" subjects_affected="3" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Respiratory tract congestion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" events="39" subjects_affected="32" subjects_at_risk="1493"/>
                <counts group_id="E2" events="33" subjects_affected="25" subjects_at_risk="1497"/>
                <counts group_id="E3" events="41" subjects_affected="39" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Sinus congestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Sinus disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Sleep apnoea syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Sneezing</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1493"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Throat irritation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="1493"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="1497"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="1526"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Angioedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Dermal cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="1493"/>
                <counts group_id="E2" events="10" subjects_affected="9" subjects_at_risk="1497"/>
                <counts group_id="E3" events="17" subjects_affected="17" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Dermatitis allergic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Dermatitis atopic</sub_title>
                <counts group_id="E1" events="16" subjects_affected="15" subjects_at_risk="1493"/>
                <counts group_id="E2" events="16" subjects_affected="14" subjects_at_risk="1497"/>
                <counts group_id="E3" events="15" subjects_affected="13" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="1493"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1497"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Dermatitis diaper</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="1493"/>
                <counts group_id="E2" events="19" subjects_affected="18" subjects_at_risk="1497"/>
                <counts group_id="E3" events="21" subjects_affected="21" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Ecchymosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" events="16" subjects_affected="16" subjects_at_risk="1493"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="1497"/>
                <counts group_id="E3" events="9" subjects_affected="7" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="394" subjects_affected="288" subjects_at_risk="1493"/>
                <counts group_id="E2" events="455" subjects_affected="331" subjects_at_risk="1497"/>
                <counts group_id="E3" events="505" subjects_affected="362" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Erythema multiforme</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Ingrowing nail</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Intertrigo</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="1493"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1497"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Macule</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Miliaria</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="1493"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="1497"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Nail disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Onychomadesis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Petechiae</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Prurigo</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Rash macular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Rash papular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Rash vesicular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Seborrhoeic dermatitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1493"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Skin burning sensation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Skin discolouration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Skin irritation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Skin lesion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Skin ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Skin warm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1493"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1497"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Spider naevus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Swelling face</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="1493"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="1497"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="1526"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1493"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1497"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1526"/>
              </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/NCT01681992
org study id: 115649
secondary id: 2011-004905-26
nct id: NCT01681992
lead sponsor: 
The purpose of this study is to evaluate end of shelf-life potency in terms of the
      immunogenicity and safety of GSK Biologicals' trivalent MMR vaccine, by comparing it to Merck
      & Co., Inc.'s MMR vaccine, which is approved for use in the United States (US).
This trial is a Phase IIIA, randomized, observer-blind, controlled, multi-center,
      multi-country study with four parallel groups. This study will evaluate the immunogenicity
      and safety of GSK Biologicals' trivalent investigational MMR vaccine (referred to as Inv_MMR
      vaccine, throughout this document) in contrast to the US standard of care comparator vaccine
      (M-M-R II, Merck and Co., Inc., referred to as Com_MMR throughout this document) in children
      during their second year of life. The first dose of this two-dose study is designed to
      establish the end of shelf-life potency of Inv_MMR vaccine. The Inv_MMR vaccine will be given
      as one of two lots; one of a minimum potency, designated Inv_MMR_Min; and the other at a
      mid-range or medium potency designated Inv_MMR_Med to two groups. The second dose for both of
      these Inv_MMR groups will have a potency within the release range of the marketed vaccine.
      The Com_MMR vaccine will consist of two lots designated Com_MMR_L1 and Com_MMR_L2 and will be
      analyzed as pooled lots within the study. The first MMR vaccine dose will be co-administered
      with Varivax, Havrix and (in the US sub-cohort only) Prevnar 13 which are routinely
      administered to children of this age in the US.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value (by Enzyme-linked Immunosorbent Assay [ELISA])
time frame: At Day 42
description: For measles virus, a seroresponse was defined as post-vaccination anti-measles virus antibody concentration equal or above [≥] 200 mIU/mL (ELISA) among subjects who were seronegative (antibody concentration less than [<] 150 mIU/mL) before dose 1. Criteria to demonstrate an acceptable immune response of Inv_MMR_Min/Inv_MMR_Med vaccine in terms of seroresponse rate for measles virus at Day 42: The lower limit of the two-sided 97.5% CI for the seroresponse rate of Inv_MMR_Min/Inv_MMR_Med was to be ≥ 90% for antibodies to measles virus.
measure: Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA)
time frame: At Day 42
description: For mumps virus, a seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 10 EU/mL (ELISA) among subjects who were seronegative (antibody concentration < 5 EU/mL) before dose 1. Criteria to demonstrate an acceptable immune response of Inv_MMR_Min/Inv_MMR_Med vaccine in terms of seroresponse rate for mumps virus at Day 42: The lower limit of the two-sided 97.5% CI for the seroresponse rate of Inv_MMR_Min/Inv_MMR_Med was to be ≥ 90% for antibodies to mumps virus.
measure: Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value (by Plaque Reduction Neutralization Test [PRNT])
time frame: At Day 42
description: For mumps virus as measured by PRNT, a seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 4 End point Dilution 50% (ED50) (PRNT) among subjects who were seronegative (antibody concentration < 2.5 ED50) before dose 1.
measure: Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA)
time frame: At Day 42
description: For rubella virus, a seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥ 10 IU/mL (ELISA) among subjects who were seronegative (antibody concentration < 4 IU/mL) before dose 1. Criteria to demonstrate an acceptable immune response of Inv_MMR_Min/Inv_MMR_Med vaccine in terms of seroresponse rate for rubella virus at Day 42: The lower limit of the two-sided 97.5% CI for the seroresponse rate of Inv_MMR_Min/Inv_MMR_Med was to be ≥ 90% for antibodies to mumps virus.
measure: Anti-measles Virus Antibody Concentrations (by ELISA)
time frame: At Day 42
description: Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL.
measure: Anti-mumps Virus Antibody Concentrations (by ELISA)
time frame: At Day 42
description: Antibody concentrations were expressed as GMCs in EU/mL.
measure: Anti-mumps Virus Antibody Concentrations (by PRNT)
time frame: At Day 42
description: Antibody concentrations were expressed as Geometric Mean Titers (GMTs).
measure: Anti-rubella Virus Antibody Concentrations (by ELISA)
time frame: At Day 42
description: Antibody concentrations were expressed as GMCs in IU/mL.
measure: Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA)
time frame: At Day 84
description: For measles virus, a seroresponse was defined as post-vaccination anti-measles virus antibody concentration ≥ 200 mIU/mL (ELISA) among subjects who were seronegative (antibody concentration < 150 mIU/mL) before dose 1.
measure: Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA)
time frame: At Day 84
description: For mumps virus, a seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 10 EU/mL (ELISA) among subjects who were seronegative (antibody concentration < 5 EU/mL) before dose 1.
measure: Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA)
time frame: At Day 84
description: For rubella virus, a seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥ 10 IU/mL (ELISA) among subjects who were seronegative (antibody concentration < 4 IU/mL) before dose 1.
measure: Anti-measles Virus Antibody Concentrations (by ELISA)
time frame: At Day 84
description: Antibody concentrations were expressed as GMCs in mIU/mL.
measure: Anti-mumps Virus Antibody Concentrations (by ELISA)
time frame: At Day 84
description: Antibody concentrations were expressed as GMCs in EU/mL.
measure: Anti-rubella Virus Antibody Concentrations (by ELISA)
time frame: At Day 84
description: Antibody concentrations were expressed as GMCs in IU/mL.
measure: Number of Subjects With Any Solicited Local Adverse Events (AEs) Post Dose 1
time frame: During the 4-day (Days 0-3) post-vaccination period
description: Assessed solicited local AEs were pain, redness and swelling. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.
measure: Number of Subjects With Any Solicited Local AEs Post Dose 2
time frame: During the 4-day (Days 0-3) post-vaccination period
description: Assessed solicited local AEs were pain, redness and swelling. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.
measure: Number of Subjects With Any Solicited General AEs Post Dose 1
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 the AE regardless of intensity grade or relation to vaccination.
measure: Number of Subjects Reporting Any Fever Post Dose 1
time frame: During the 43-day (Days 0-42) post-vaccination period
description: Any fever = Fever (axillary) ≥ 38°C.
measure: Number of Subjects Reporting Any Fever Post Dose 2
time frame: During the 43-day (Days 0-42) post-vaccination period
description: Any fever = Fever (axillary) ≥ 38°C.
measure: Number of Subjects Reporting Any Rash Post Dose 1
time frame: During the 43-day (Days 0-42) post-vaccination period
description: Assessed were any localized or generalized rash, rash with fever, varicella-like rash and measles/rubella-like rash. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.
measure: Number of Subjects Reporting Any Rash Post Dose 2
time frame: During the 43-day (Days 0-42) post-vaccination period
description: Assessed were any localized or generalized rash, rash with fever, varicella-like rash and measles/rubella-like rash. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.
measure: Number of Subjects Reporting Any MMR Specific Solicited General AEs Post Dose 1
time frame: During the 43-day (Days 0-42) post-vaccination period
description: Assessed MMR specific solicited general AEs were any suspected signs of meningism including febrile convulsions and parotid/salivary gland swelling. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.
measure: Number of Subjects Reporting Any MMR Specific Solicited General AEs Post Dose 2
time frame: During the 43-day (Days 0-42) post-vaccination period
description: Assessed MMR specific solicited general AEs were any suspected signs of meningism including febrile convulsions and parotid/salivary gland swelling. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.
measure: Number of Subjects Reporting Any Unsolicited AES Post Dose 1
time frame: During the 43-day (Days 0-42) post-vaccination period
description: Unsolicited AE was defined as any AE reported in 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 the AE regardless of intensity grade or relation to vaccination.
measure: Number of Subjects Reporting Any Unsolicited AES Post Dose 2
time frame: During the 43-day (Days 0-42) post-vaccination period
description: Unsolicited AE was defined as any AE reported in 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 the AE regardless of intensity grade or relation to vaccination.
measure: Number of Subjects Reporting Any AEs of Specific Interest
time frame: From Day 0 through the end of the study (Day 222)
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: From Day 0 through the end of the study (Day 222)
description: SAEs assessed include any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization or resulted in disability/incapacity.
arm group label: Inv_MMR_Min Group
arm group type: Experimental
description: Subjects receive one dose of GlaxoSmithKline (GSK) Biologicals' measles, mumps, rubella (MMR) vaccine, Priorix (Inv_MMR), from a minimum potency lot (Inv_MMR_Min), co-administered with Varivax (VV) and Havrix (HAV) vaccines at Day 0. All US subjects are also co-administered Prevnar 13 (PCV-13) vaccine. Approximately 6 weeks later, at Day 42, subjects are administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines are administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines are administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
arm group label: Inv_MMR_Med Group
arm group type: Experimental
description: Subjects receive one dose of GlaxoSmithKline (GSK) Biologicals' measles, mumps, rubella (MMR) vaccine, Priorix (Inv_MMR), from a mid-range or medium potency lot (Inv_MMR_Med), co-administered with Varivax (VV) and Havrix (HAV) vaccines at Day 0. All US subjects are also co-administered Prevnar 13 (PCV-13) vaccine. Approximately 6 weeks later, at Day 42, subjects are administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines are administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines are administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
arm group label: Com_MMR Group
arm group type: Active Comparator
description: Subjects receive one dose of M-M-R II (Com_MMR) vaccine (Lot 1 or Lot 2), co-administered with Varivax (VV) and Havrix (HAV) vaccines at Day 0. All US subjects are also co-administered Prevnar 13 (PCV-13) vaccine. Approximately 6 weeks later, at Day 42, subjects are administered a dose of Com_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com_MMR and VV vaccines are administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines are administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
intervention type: Biological
intervention name: Priorix
description: Subjects receive one dose of either minimum (Inv_MMR_Min) or medium (Inv_MMR_Med) potency lot at Day 0 and a dose of separate potency lot (Inv_MMR_Release) at Day 42, administered subcutaneously in the triceps region of the left arm.
arm group label: Inv_MMR_Med Group
arm group label: Inv_MMR_Min Group
other name: GSK Biologicals' live attenuated measles
other name: mumps
other name: rubella vaccine
intervention type: Biological
intervention name: M-M-R II
description: Subjects receive two doses of either Lot 1 or Lot 2, one at Day 0 and one at Day 42, administered subcutaneously in the triceps region of the left arm.
arm group label: Com_MMR Group
other name: Merck & Co.
other name: Inc.'s measles
other name: mumps
other name: rubella virus vaccine
other name: live
intervention type: Biological
intervention name: Varivax
description: Subjects receive one dose co-administered subcutaneously with the study vaccines (Priorix and M-M-R II), in the triceps region of right arm, at Day 0.
arm group label: Com_MMR Group
arm group label: Inv_MMR_Med Group
arm group label: Inv_MMR_Min Group
other name: Merck & Co.
other name: Inc.'s varicella virus vaccine
other name: live
intervention type: Biological
intervention name: Havrix
description: Subjects receive one dose co-administered intramuscularly with the study vaccines (Priorix and M-M-R II), in the anterolateral region of the right thigh, at Day 0.
arm group label: Com_MMR Group
arm group label: Inv_MMR_Med Group
arm group label: Inv_MMR_Min Group
other name: GSK Biologicals' hepatitis A vaccine
other name: inactivated
intervention type: Biological
intervention name: Prevnar 13
description: US Subjects receive one dose co-administered intramuscularly with the study vaccines (Priorix and M-M-R II), in the anterolateral region of the left thigh, at Day 0.
arm group label: Com_MMR Group
arm group label: Inv_MMR_Med Group
arm group label: Inv_MMR_Min Group
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: Czechia
country: Finland
country: Malaysia
country: Puerto Rico
country: Spain
country: Thailand
country: United States
country: Czech Republic
citation: MMR-161 Study Group. Immunogenicity and safety of measles-mumps-rubella vaccine at two different potency levels administered to healthy children aged 12-15 months: A phase III, randomized, non-inferiority trial. Vaccine. 2018 Sep 11;36(38):5781-5788. doi: 10.1016/j.vaccine.2018.07.076. Epub 2018 Aug 10.
PMID: 30104117
responsible party type: Sponsor
mesh term: Measles
mesh term: Rubella
mesh term: Mumps
mesh term: Vaccines
participant flow: 
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outcome list: 
reported events: 
certain agreements: 
point of contact: 