<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/NCT01702428</url>
  </required_header>
  <id_info>
    <org_study_id>115648</org_study_id>
    <secondary_id>2011-004891-12</secondary_id>
    <nct_id>NCT01702428</nct_id>
  </id_info>
  <brief_title>Consistency Study of GlaxoSmithKline (GSK) Biologicals' MMR Vaccine (209762) (Priorix) Comparing Immunogenicity and Safety to Merck &amp; Co., Inc.'s MMR Vaccine (M-M-R II), in Children 12 to 15 Months of Age</brief_title>
  <official_title>Consistency Study of GSK Biologicals' Measles-mumps-rubella (MMR) Vaccine (209762) (Priorix) Comparing Immunogenicity and Safety to Merck &amp; Co., Inc.'s MMR Vaccine (M-M-R II), in Healthy Children 12 to 15 Months of Age</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate consistency in terms of the immune response to three&#xD;
      different lots of GSK Biologicals' trivalent MMR vaccine manufactured to target potencies,&#xD;
      and compare its immunogenicity to Merck &amp; Co., Inc.'s MMR vaccine, which is approved for use&#xD;
      in the United States (US).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will evaluate the consistency of the immune response to three different lots of&#xD;
      GSK Biologicals' trivalent investigational MMR vaccine (referred to as INV_MMR vaccine,&#xD;
      throughout this document) and compare its immunogenicity to the US standard of care&#xD;
      comparator vaccine (M-M-R II, Merck and Co., Inc., referred to as COM_MMR throughout this&#xD;
      document) in children during their second year of life. The INV_MMR vaccine will be given as&#xD;
      one of three consistency lots manufactured to target potencies designated as INV_MMR_L1,&#xD;
      INV_MMR_L2 and INV_MMR_L3. The COM_MMR vaccine will be given as one of two lots designated&#xD;
      COM_MMR_L1 and COM_MMR_L2 and will be analysed as pooled lots within the study. The MMR&#xD;
      vaccine will be co-administered with Varivax (VV), Havrix (HAV) and (in the US sub-cohort&#xD;
      only) Prevnar 13 (PCV-13) which are routinely administered to children of this age in the US.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 9, 2012</start_date>
  <completion_date type="Actual">April 16, 2015</completion_date>
  <primary_completion_date type="Actual">November 25, 2014</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</measure>
    <time_frame>At Day 42</time_frame>
    <description>Seroresponse was defined as post-vaccination anti-measles virus antibody concentration ≥200 milli International Unit/Milliliter (mIU/mL) among subjects who were seronegative (antibody concentration &lt;150 mIU/mL) before vaccination. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anti-measles Virus Antibody Concentrations</measure>
    <time_frame>At Day 42</time_frame>
    <description>Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value</measure>
    <time_frame>At Day 42</time_frame>
    <description>Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥10 ELISA Unit/Milliliter (EU/mL) among subjects who were seronegative (antibody concentrations &lt;5 EU/mL) before vaccination. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anti-mumps Virus Antibody Concentration</measure>
    <time_frame>At Day 42</time_frame>
    <description>Antibody concentrations were expressed as GMCs in EU/mL. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value</measure>
    <time_frame>At Day 42</time_frame>
    <description>Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥10 International Unit/Milliliter (IU/mL) among subjects who were seronegative (antibody concentrations &lt;4 IU/mL) before vaccination. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anti-rubella Virus Antibody Concentration</measure>
    <time_frame>At Day 42</time_frame>
    <description>Antibody concentrations were expressed as GMCs in IU/mL. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups</measure>
    <time_frame>At Day 42</time_frame>
    <description>Seroresponse was defined as post-vaccination anti-measles virus antibody concentration ≥200 mIU/mL among subjects who were seronegative (antibody concentration &lt;150 mIU/mL) before vaccination. Criteria to demonstrate an acceptable immune response for INV_MMR in terms of seroresponse rates to measles virus at Day 42: The LL of 2-sided 95% CI for the seroresponse rate for the pooled INV_MMR lots is ≥90% for antibodies to measles virus.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anti-measles Virus Antibody Concentrations in Pooled MMR Groups</measure>
    <time_frame>At Day 42</time_frame>
    <description>Antibody concentrations were expressed as GMCs in mIU/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups</measure>
    <time_frame>At Day 42</time_frame>
    <description>Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥10 EU/mL among subjects who were seronegative (antibody concentrations &lt;5 EU/mL) before vaccination.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anti-mumps Virus Antibody Concentration in Pooled MMR Groups</measure>
    <time_frame>At Day 42</time_frame>
    <description>Antibody concentrations were expressed as GMCs in EU/mL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups</measure>
    <time_frame>At Day 42</time_frame>
    <description>Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥10 IU/mL among subjects who were seronegative (antibody concentrations &lt;4 IU/mL) before vaccination. Criteria to demonstrate an acceptable immune response for INV_MMR in terms of seroresponse rates to rubella virus at Day 42: The LL of 2-sided 95% CI for the seroresponse rate for the pooled INV_MMR lots is ≥90% for antibodies to rubella virus.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anti-rubella Virus Antibody Concentration in Pooled MMR Groups</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 an Anti-Varicella Zoster Virus (VZV) Antibody Concentration Equal to or Above the Cut-off Value in US Sub-cohort of Pooled MMR Groups</measure>
    <time_frame>At Day 42</time_frame>
    <description>Seroresponse was defined as post-vaccination anti-VZV antibody concentration ≥75 mIU/mL among subjects who were seronegative (antibody concentration &lt;25 mIU/mL) before vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-VZV Virus Antibody Concentration in US Sub-cohort of Pooled MMR Groups</measure>
    <time_frame>At Day 42</time_frame>
    <description>Antibody concentrations were expressed as GMCs in mIU/mL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects With an Anti-HAV Antibody Concentration Equal to or Above the Cut-off Value in US Sub-cohort of Pooled MMR Groups</measure>
    <time_frame>At Day 42</time_frame>
    <description>Percentage of subjects with an Anti-HAV antibody concentration equal to or above 15 mIU/mL were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-HAV Antibody Concentrations in US Sub-cohort of Pooled MMR Groups</measure>
    <time_frame>At Day 42</time_frame>
    <description>Antibody concentrations were expressed as GMCs in mIU/mL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-S.Pneumoniae Antibody Concentration in US Sub-cohort of Pooled MMR Groups</measure>
    <time_frame>At Day 42</time_frame>
    <description>Antibody concentrations were expressed as GMCs in microgram/Milliliter (µg/mL).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Any Solicited Local Adverse Events (AEs)</measure>
    <time_frame>During the 4-days (Days 0-3) post-vaccination period</time_frame>
    <description>Assessed solicited local AEs were pain, redness and swelling. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Any Solicited General AEs</measure>
    <time_frame>During the 15-days (Days 0-14) post-vaccination period</time_frame>
    <description>Assessed solicited general AEs were drowsiness, irritability and loss of appetite. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Any Fever</measure>
    <time_frame>During the 43-days (Days 0-42) post-vaccination period</time_frame>
    <description>Any fever = Fever ≥ 38°C.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Any Rash</measure>
    <time_frame>During the 43-days (Days 0-42) post-vaccination period</time_frame>
    <description>Assessed were any localized or generalized rash, rash with fever, varicella-like rash, measles/rubella-like rash. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Any MMR Specific Solicited AEs</measure>
    <time_frame>During the 43-days (Days 0-42) post-vaccination period</time_frame>
    <description>Assessed MMR specific solicited AEs were any suspected signs of meningism including febrile convulsions and parotid/salivary gland swelling. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Any Unsolicited AEs</measure>
    <time_frame>During the 43-days (Days 0-42) post-vaccination period</time_frame>
    <description>Unsolicited adverse event (AE) was defined as any adverse event reported in addition to those solicited during the clinical study and also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting AEs of Specific Interest</measure>
    <time_frame>From Day 0 through the end of study (Day 180)</time_frame>
    <description>AEs of specific interest included new onset chronic disease (NOCD) (e.g., autoimmune disorders, asthma, type I diabetes, vasculitis, celiac disease, conditions associated with sub-acute or chronic thrombocytopenia and allergies) and AEs prompting emergency room (ER) visits.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Any Serious Adverse Events (SAEs)</measure>
    <time_frame>From Day 0 through the end of study (Day 180)</time_frame>
    <description>SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity. Any SAE = Occurrence of SAE regardless of intensity grade or relation to vaccination.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">5016</enrollment>
  <condition>Rubella</condition>
  <condition>Measles</condition>
  <condition>Mumps</condition>
  <arm_group>
    <arm_group_label>INV_MMR_L1 Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects receive 1 dose of GSK's candidate combined measles, mumps and rubella (MMR) investigational vaccine (INV_MMR) Lot 1 (L1) co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects are also given PCV-13 vaccine. The MMR vaccine is administered subcutaneously in the triceps region of the left arm while the VV vaccine is administered subcutaneously in the triceps region of the right arm. 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_L2 Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects receive 1 dose of GSK's candidate combined measles, mumps and rubella (MMR) investigational vaccine (INV_MMR) Lot 2 (L2) co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects are also given PCV-13 vaccine. The MMR vaccine is administered subcutaneously in the triceps region of the left arm while the VV vaccine is administered subcutaneously in the triceps region of the right arm. 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_L3 Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects receive 1 dose of GSK's candidate combined measles, mumps and rubella (MMR) investigational vaccine (INV_MMR) Lot 3 (L3) co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects are also given PCV-13 vaccine. The MMR vaccine is administered subcutaneously in the triceps region of the left arm while the VV vaccine is administered subcutaneously in the triceps region of the right arm. 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 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects are also given PCV-13 vaccine. The MMR vaccine is administered subcutaneously in the triceps region of the left arm while the VV vaccine is administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines are administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis is conducted for this group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Priorix</intervention_name>
    <description>Subjects receive 1 dose of MMR vaccine which is administered subcutaneously in the triceps region of the left arm.</description>
    <arm_group_label>INV_MMR_L1 Group</arm_group_label>
    <arm_group_label>INV_MMR_L2 Group</arm_group_label>
    <arm_group_label>INV_MMR_L3 Group</arm_group_label>
    <other_name>GSK Biologicals' live attenuated measles</other_name>
    <other_name>mumps and rubella vaccine (GSK209762)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>M-M-R II</intervention_name>
    <description>Subjects receive 1 dose of MMR vaccine which is administered subcutaneously in the triceps region of the left arm.</description>
    <arm_group_label>COM_MMR Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Varivax</intervention_name>
    <description>Subjects receive 1 dose of VV vaccine which is administered subcutaneously in the triceps region of the right arm.</description>
    <arm_group_label>COM_MMR Group</arm_group_label>
    <arm_group_label>INV_MMR_L1 Group</arm_group_label>
    <arm_group_label>INV_MMR_L2 Group</arm_group_label>
    <arm_group_label>INV_MMR_L3 Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Havrix</intervention_name>
    <description>Subjects receive 1 dose of HAV vaccine which is administered intramuscularly in the anterolateral region of the right thigh.</description>
    <arm_group_label>COM_MMR Group</arm_group_label>
    <arm_group_label>INV_MMR_L1 Group</arm_group_label>
    <arm_group_label>INV_MMR_L2 Group</arm_group_label>
    <arm_group_label>INV_MMR_L3 Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Prevnar 13</intervention_name>
    <description>US subjects receive 1 dose of PCV-13 vaccine which is administered intramuscularly in the anterolateral region of the left thigh.</description>
    <arm_group_label>COM_MMR Group</arm_group_label>
    <arm_group_label>INV_MMR_L1 Group</arm_group_label>
    <arm_group_label>INV_MMR_L2 Group</arm_group_label>
    <arm_group_label>INV_MMR_L3 Group</arm_group_label>
  </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 only (i.e., no doses given&#xD;
        as Prevnar/Prevenar), with the last dose at least 60 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 (i.e., 30 days&#xD;
             prior to Day 0) or planned use 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.&#xD;
&#xD;
          -  Chronic administration of immunosuppressants, or other immune-modifying drugs during&#xD;
             the period starting 180 days prior to the first vaccine dose or any planned&#xD;
             administration of immunosuppressive and immune-modifying drugs during the entire&#xD;
             study.&#xD;
&#xD;
               -  For corticosteroids, this will mean prednisone, ≥0.5 mg/kg/day or equivalent.&#xD;
&#xD;
               -  Inhaled and topical steroids are allowed.&#xD;
&#xD;
          -  Planned administration/ administration of a vaccine not foreseen by the study protocol&#xD;
             during the period starting 30 days prior to study vaccination at Visit 1 and ending at&#xD;
             Visit 2. Please Note:&#xD;
&#xD;
               -  Inactivated influenza (Flu) vaccine and Haemophilus influenzae type b conjugate&#xD;
                  vaccine (Hib) vaccines may be given at any time, including the day of study&#xD;
                  vaccination (Flu and Hib vaccines must be administered at a different location&#xD;
                  than the study vaccine/s).&#xD;
&#xD;
               -  Any other age appropriate vaccine may be given starting at Visit 2 and anytime&#xD;
                  thereafter.&#xD;
&#xD;
          -  Administration of immunoglobulins and/or any blood products during the period starting&#xD;
             180 days prior to study vaccination at Visit 1 or planned administration from the date&#xD;
             of vaccination through the immunogenicity evaluation at Visit 2.&#xD;
&#xD;
          -  History of measles, mumps, rubella, varicella/zoster and/or hepatitis A disease.&#xD;
&#xD;
          -  Known exposure to measles, mumps, rubella and/or varicella/zoster during the period&#xD;
             starting within 30 days prior to first study vaccination.&#xD;
&#xD;
          -  Previous vaccination against measles, mumps, rubella, hepatitis A and/or varicella&#xD;
             virus.&#xD;
&#xD;
          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on&#xD;
             medical history and physical examination.&#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. All vaccines can be administered to persons&#xD;
             with a minor illness such as diarrhea, mild upper respiratory infection 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;
          -  Child that previously received a vaccination with heptavalent Prevnar/Prevenar (prior&#xD;
             vaccination should be with 3 doses of Prevnar 13 only).&#xD;
&#xD;
          -  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>Dothan</city>
        <state>Alabama</state>
        <zip>36305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Fayetteville</city>
        <state>Arkansas</state>
        <zip>72703</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Daly City</city>
        <state>California</state>
        <zip>94015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93726</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hayward</city>
        <state>California</state>
        <zip>94545</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Los Gatos</city>
        <state>California</state>
        <zip>95032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Mission Hills</city>
        <state>California</state>
        <zip>91345</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Paramount</city>
        <state>California</state>
        <zip>90723</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Pleasanton</city>
        <state>California</state>
        <zip>94588</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95815</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95823</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Santa Clara</city>
        <state>California</state>
        <zip>95051</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Walnut Creek</city>
        <state>California</state>
        <zip>94596</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80922</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Nampa</city>
        <state>Idaho</state>
        <zip>83686</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Evergreen Park</city>
        <state>Illinois</state>
        <zip>60805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ames</city>
        <state>Iowa</state>
        <zip>50010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Augusta</city>
        <state>Kansas</state>
        <zip>67010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Topeka</city>
        <state>Kansas</state>
        <zip>66604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bossier City</city>
        <state>Louisiana</state>
        <zip>71111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Columbia</city>
        <state>Maryland</state>
        <zip>21045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Fall River</city>
        <state>Massachusetts</state>
        <zip>02721</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Niles</city>
        <state>Michigan</state>
        <zip>49120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Stevensville</city>
        <state>Michigan</state>
        <zip>49127</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ithaca</city>
        <state>New York</state>
        <zip>14850</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45245</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Erie</city>
        <state>Pennsylvania</state>
        <zip>16505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hermitage</city>
        <state>Pennsylvania</state>
        <zip>16148</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sellersville</city>
        <state>Pennsylvania</state>
        <zip>18960</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Warwick</city>
        <state>Rhode Island</state>
        <zip>02886</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Barnwell</city>
        <state>South Carolina</state>
        <zip>29812</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kingsport</city>
        <state>Tennessee</state>
        <zip>37660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77070</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>League City</city>
        <state>Texas</state>
        <zip>77573</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tomball</city>
        <state>Texas</state>
        <zip>77375</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Layton</city>
        <state>Utah</state>
        <zip>84041</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Payson</city>
        <state>Utah</state>
        <zip>84651</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Provo</city>
        <state>Utah</state>
        <zip>84604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Roy</city>
        <state>Utah</state>
        <zip>84067</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Saint George</city>
        <state>Utah</state>
        <zip>84790</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Syracuse</city>
        <state>Utah</state>
        <zip>84075</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>West Jordan</city>
        <state>Utah</state>
        <zip>84088</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Falls Church</city>
        <state>Virginia</state>
        <zip>22042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Marshfield</city>
        <state>Wisconsin</state>
        <zip>54449</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tallinn</city>
        <zip>10117</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tallinn</city>
        <zip>10617</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tallinn</city>
        <zip>13419</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tallinn</city>
        <zip>13619</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tartu</city>
        <zip>50106</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Espoo</city>
        <zip>02230</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Helsinki</city>
        <zip>00100</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Helsinki</city>
        <zip>00930</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Jarvenpaa</city>
        <zip>04400</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kokkola</city>
        <zip>67100</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>Pori</city>
        <zip>28100</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Seinajoki</city>
        <zip>60100</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>Durango</city>
        <zip>34000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Mexico</city>
        <zip>04530</zip>
        <country>Mexico</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>Castellón</city>
        <zip>12004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Castellón</city>
        <zip>12530</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>Quart De Poblet, Valencia</city>
        <zip>46930</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Valencia</city>
        <zip>46011</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Valencia</city>
        <zip>46017</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>46022</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Valencia</city>
        <zip>46023</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_countries>
    <country>Estonia</country>
    <country>Finland</country>
    <country>Mexico</country>
    <country>Puerto Rico</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Klein NP, Abu-Elyazeed R, Povey M, Macias Parra M, Diez-Domingo J, Ahonen A, Korhonen T, Tinoco JC, Weiner L, Marshall GS, Silas PE, Sarpong KO, Ramsey KP, Fling JA, Speicher D, Campos M, Munjal I, Peltier C, Vesikari T, Baccarini C, Caplanusi A, Gillard P, Carryn S, Henry O. Immunogenicity and Safety of a Measles-Mumps-Rubella Vaccine Administered as a First Dose to Children Aged 12 to 15 Months: A Phase III, Randomized, Noninferiority, Lot-to-Lot Consistency Study. J Pediatric Infect Dis Soc. 2020 Apr 30;9(2):194-201. doi: 10.1093/jpids/piz010.</citation>
    <PMID>30849175</PMID>
  </reference>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>October 4, 2012</study_first_submitted>
  <study_first_submitted_qc>October 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2012</study_first_posted>
  <results_first_submitted>August 5, 2016</results_first_submitted>
  <results_first_submitted_qc>May 30, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">June 28, 2018</results_first_posted>
  <disposition_first_submitted>November 23, 2015</disposition_first_submitted>
  <disposition_first_submitted_qc>November 23, 2015</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">December 24, 2015</disposition_first_posted>
  <last_update_submitted>November 14, 2019</last_update_submitted>
  <last_update_submitted_qc>November 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Safety</keyword>
  <keyword>Consistency study</keyword>
  <keyword>Measles, mumps and rubella diseases</keyword>
  <keyword>Healthy children</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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heptavalent Pneumococcal Conjugate Vaccine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>IPD is available via the Clinical Study Data Request site (click on the link provided below)</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>IPD is available via the Clinical Study Data Request site (click on the link provided below)</ipd_time_frame>
    <ipd_access_criteria>Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.</ipd_access_criteria>
    <ipd_url>https://clinicalstudydatarequest.com/Posting.aspx?ID=19887</ipd_url>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>13 subjects from 5016 were allocated subject number but no study vaccine was administered. Therefore, the number of subjects started is 5003.</recruitment_details>
      <pre_assignment_details>Sub-cohorts for this study were as follows: • US sub-cohort: Subjects recruited in US and received INV_MMR or COM_MMR co-administered with Varivax (VV), Havrix (HAV) and Prevnar (PCV-13) vaccines at Visit 1 (Day 0). • Non-US sub-cohort: Subjects recruited outside US and received INV_MMR or COM_MMR co-administered with VV and HAV vaccines at Day 0.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>INV_MMR_L1 Group</title>
          <description>Subjects received 1 dose of GSK's candidate combined measles, mumps and rubella (MMR) investigational vaccine (INV_MMR) Lot 1 (L1) co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. 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_L2 Group</title>
          <description>Subjects received 1 dose of GSK's candidate combined measles, mumps and rubella (MMR) investigational vaccine (INV_MMR) Lot 2 (L2) co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. 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>INV_MMR_L3 Group</title>
          <description>Subjects received 1 dose of GSK's candidate combined measles, mumps and rubella (MMR) investigational vaccine (INV_MMR) Lot 3 (L3) co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
        </group>
        <group group_id="P4">
          <title>COM_MMR Group</title>
          <description>Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1239"/>
                <participants group_id="P2" count="1232"/>
                <participants group_id="P3" count="1243"/>
                <participants group_id="P4" count="1289"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1175"/>
                <participants group_id="P2" count="1162"/>
                <participants group_id="P3" count="1190"/>
                <participants group_id="P4" count="1232"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="64"/>
                <participants group_id="P2" count="70"/>
                <participants group_id="P3" count="53"/>
                <participants group_id="P4" count="57"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="41"/>
                <participants group_id="P3" count="37"/>
                <participants group_id="P4" count="44"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Parents cannot assist to site</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost Coverage</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost Health Plan</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Mother transferred care</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Parents too busy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="23"/>
                <participants group_id="P3" count="14"/>
                <participants group_id="P4" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>INV_MMR_L1 Group</title>
          <description>Subjects received 1 dose of INV_MMR_L1 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. 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_L2 Group</title>
          <description>Subjects received 1 dose of INV_MMR_L2 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. 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>INV_MMR_L3 Group</title>
          <description>Subjects received 1 dose of INV_MMR_L3 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. 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>COM_MMR Group</title>
          <description>Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1239"/>
            <count group_id="B2" value="1232"/>
            <count group_id="B3" value="1243"/>
            <count group_id="B4" value="1289"/>
            <count group_id="B5" value="5003"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12.3" spread="0.7"/>
                    <measurement group_id="B2" value="12.3" spread="0.7"/>
                    <measurement group_id="B3" value="12.3" spread="0.7"/>
                    <measurement group_id="B4" value="12.3" spread="0.7"/>
                    <measurement group_id="B5" value="12.3" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="607"/>
                    <measurement group_id="B2" value="594"/>
                    <measurement group_id="B3" value="615"/>
                    <measurement group_id="B4" value="618"/>
                    <measurement group_id="B5" value="2434"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="632"/>
                    <measurement group_id="B2" value="638"/>
                    <measurement group_id="B3" value="628"/>
                    <measurement group_id="B4" value="671"/>
                    <measurement group_id="B5" value="2569"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White - Arabic / North African Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian - Central/South Asian Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="170"/>
                    <measurement group_id="B2" value="155"/>
                    <measurement group_id="B3" value="162"/>
                    <measurement group_id="B4" value="163"/>
                    <measurement group_id="B5" value="650"/>
                  </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="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>American Indian or Alaskan Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="33"/>
                    <measurement group_id="B4" value="31"/>
                    <measurement group_id="B5" value="126"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White - Caucasian / European Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="932"/>
                    <measurement group_id="B2" value="938"/>
                    <measurement group_id="B3" value="944"/>
                    <measurement group_id="B4" value="970"/>
                    <measurement group_id="B5" value="3784"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian - South East Asian Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="21"/>
                    <measurement group_id="B4" value="26"/>
                    <measurement group_id="B5" value="93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>African Heritage / African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                    <measurement group_id="B2" value="52"/>
                    <measurement group_id="B3" value="57"/>
                    <measurement group_id="B4" value="70"/>
                    <measurement group_id="B5" value="239"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian - Japanese Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian - East Asian Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="38"/>
                  </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</title>
        <description>Seroresponse was defined as post-vaccination anti-measles virus antibody concentration ≥200 milli International Unit/Milliliter (mIU/mL) among subjects who were seronegative (antibody concentration &lt;150 mIU/mL) before vaccination. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.</description>
        <time_frame>At Day 42</time_frame>
        <population>According to protocol (ATP) cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination &amp; with pre &amp; post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample &amp; complied with post dose blood sample schedule</population>
        <group_list>
          <group group_id="O1">
            <title>INV_MMR _L1 Group</title>
            <description>Subjects received 1 dose of INV_MMR_L1 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. 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 _L2 Group</title>
            <description>Subjects received 1 dose of INV_MMR_L2 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. 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>INV_MMR _L3 Group</title>
            <description>Subjects received 1 dose of INV_MMR_L3 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. 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</title>
          <description>Seroresponse was defined as post-vaccination anti-measles virus antibody concentration ≥200 milli International Unit/Milliliter (mIU/mL) among subjects who were seronegative (antibody concentration &lt;150 mIU/mL) before vaccination. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.</description>
          <population>According to protocol (ATP) cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination &amp; with pre &amp; post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample &amp; complied with post dose blood sample schedule</population>
          <units>Percentage of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1083"/>
                <count group_id="O2" value="1069"/>
                <count group_id="O3" value="1096"/>
              </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="98.2" lower_limit="97.3" upper_limit="98.9"/>
                    <measurement group_id="O2" value="98.9" lower_limit="98.0" upper_limit="99.4"/>
                    <measurement group_id="O3" value="98.1" lower_limit="97.1" upper_limit="98.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anti-measles ≥ 200 mIU/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.1" lower_limit="97.1" upper_limit="98.8"/>
                    <measurement group_id="O2" value="98.6" lower_limit="97.7" upper_limit="99.2"/>
                    <measurement group_id="O3" value="97.8" lower_limit="96.8" upper_limit="98.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Difference between groups (INV_MMR_L1 Group minus INV_MMR_L2 Group) in percentage of subjects with anti-measles antibody concentration ≥200 mIU/mL.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence (legacy)</non_inferiority_type>
            <non_inferiority_desc>For each pair-wise comparison, the 2-sided 95% confidence interval (CI) on the lot difference in seroresponse rates should be within the [-5%;5%] margin for antibodies to measles virus.</non_inferiority_desc>
            <param_type>Difference in seroresponse rate</param_type>
            <param_value>-0.54</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.69</ci_lower_limit>
            <ci_upper_limit>0.58</ci_upper_limit>
            <estimate_desc>Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Difference between groups (INV_MMR_L2 Group minus INV_MMR_L3 Group) in percentage of subjects with anti-measles antibody concentration ≥200 mIU/mL.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence (legacy)</non_inferiority_type>
            <non_inferiority_desc>For each pair-wise comparison, the 2-sided 95% confidence interval (CI) on the lot difference in seroresponse rates should be within the [-5%;5%] margin for antibodies to measles virus.</non_inferiority_desc>
            <param_type>Difference in seroresponse rate</param_type>
            <param_value>0.79</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.35</ci_lower_limit>
            <ci_upper_limit>1.98</ci_upper_limit>
            <estimate_desc>Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Difference between groups (INV_MMR_L1 Group minus INV_MMR_L3 Group) in percentage of subjects with anti-measles antibody concentration ≥200 mIU/mL.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence (legacy)</non_inferiority_type>
            <non_inferiority_desc>For each pair-wise comparison, the 2-sided 95% confidence interval (CI) on the lot difference in seroresponse rates should be within the [-5%;5%] margin for antibodies to measles virus.</non_inferiority_desc>
            <param_type>Difference in seroresponse rate</param_type>
            <param_value>0.25</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.98</ci_lower_limit>
            <ci_upper_limit>1.50</ci_upper_limit>
            <estimate_desc>Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Anti-measles Virus Antibody Concentrations</title>
        <description>Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.</description>
        <time_frame>At Day 42</time_frame>
        <population>ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination &amp; with pre &amp; post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample &amp; complied with post dose blood sample schedule</population>
        <group_list>
          <group group_id="O1">
            <title>INV_MMR _L1 Group</title>
            <description>Subjects received 1 dose of INV_MMR_L1 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. 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 _L2 Group</title>
            <description>Subjects received 1 dose of INV_MMR_L2 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. 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>INV_MMR _L3 Group</title>
            <description>Subjects received 1 dose of INV_MMR_L3 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. 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</title>
          <description>Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.</description>
          <population>ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination &amp; with pre &amp; post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample &amp; complied with post dose blood sample schedule</population>
          <units>mIU/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1083"/>
                <count group_id="O2" value="1069"/>
                <count group_id="O3" value="1096"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2970.3" lower_limit="2813.2" upper_limit="3136.2"/>
                    <measurement group_id="O2" value="3023.6" lower_limit="2864.5" upper_limit="3191.6"/>
                    <measurement group_id="O3" value="3058.3" lower_limit="2893.9" upper_limit="3232.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Adjusted GMC ratio (INV_MMR_L1 Group divided by INV_MMR_L2 Group) for antibodies to measles virus at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence (legacy)</non_inferiority_type>
            <non_inferiority_desc>For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to measles.</non_inferiority_desc>
            <param_type>Adjusted GMC ratio</param_type>
            <param_value>0.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.91</ci_lower_limit>
            <ci_upper_limit>1.06</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Adjusted GMC ratio (INV_MMR_L1 Group divided by INV_MMR_L3 Group) for antibodies to measles virus at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence (legacy)</non_inferiority_type>
            <non_inferiority_desc>For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to measles.</non_inferiority_desc>
            <param_type>Adjusted GMC ratio</param_type>
            <param_value>0.97</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.90</ci_lower_limit>
            <ci_upper_limit>1.05</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Adjusted GMC ratio (INV_MMR_L2 Group divided by INV_MMR_L1 Group) for antibodies to measles virus at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence (legacy)</non_inferiority_type>
            <non_inferiority_desc>For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to measles.</non_inferiority_desc>
            <param_type>Adjusted GMC ratio</param_type>
            <param_value>1.01</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.94</ci_lower_limit>
            <ci_upper_limit>1.09</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Adjusted GMC ratio (INV_MMR_L2 Group divided by INV_MMR_L3 Group) for antibodies to measles virus at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence (legacy)</non_inferiority_type>
            <non_inferiority_desc>For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to measles.</non_inferiority_desc>
            <param_type>Adjusted GMC ratio</param_type>
            <param_value>0.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.91</ci_lower_limit>
            <ci_upper_limit>1.06</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Adjusted GMC ratio (INV_MMR_L3 Group divided by INV_MMR_L1 Group) for antibodies to measles virus at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence (legacy)</non_inferiority_type>
            <non_inferiority_desc>For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to measles.</non_inferiority_desc>
            <param_type>Adjusted GMC ratio</param_type>
            <param_value>1.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.95</ci_lower_limit>
            <ci_upper_limit>1.11</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Adjusted GMC ratio (INV_MMR_L3 Group divided by INV_MMR_L2 Group) for antibodies to measles virus at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence (legacy)</non_inferiority_type>
            <non_inferiority_desc>For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to measles.</non_inferiority_desc>
            <param_type>Adjusted GMC ratio</param_type>
            <param_value>1.01</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.94</ci_lower_limit>
            <ci_upper_limit>1.09</ci_upper_limit>
          </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</title>
        <description>Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥10 ELISA Unit/Milliliter (EU/mL) among subjects who were seronegative (antibody concentrations &lt;5 EU/mL) before vaccination. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.</description>
        <time_frame>At Day 42</time_frame>
        <population>ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination &amp; with pre &amp; post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample &amp; complied with post dose blood sample schedule</population>
        <group_list>
          <group group_id="O1">
            <title>INV_MMR_L1 Group</title>
            <description>Subjects received 1 dose of INV_MMR_L1 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. 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_L2 Group</title>
            <description>Subjects received 1 dose of INV_MMR_L2 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. 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>INV_MMR_L3 Group</title>
            <description>Subjects received 1 dose of INV_MMR_L3 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. 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</title>
          <description>Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥10 ELISA Unit/Milliliter (EU/mL) among subjects who were seronegative (antibody concentrations &lt;5 EU/mL) before vaccination. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.</description>
          <population>ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination &amp; with pre &amp; post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample &amp; complied with post dose blood sample schedule</population>
          <units>Percentage of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1062"/>
                <count group_id="O2" value="1047"/>
                <count group_id="O3" value="1078"/>
              </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="99.7" lower_limit="99.2" upper_limit="99.9"/>
                    <measurement group_id="O2" value="99.3" lower_limit="98.6" upper_limit="99.7"/>
                    <measurement group_id="O3" value="99.2" lower_limit="98.4" upper_limit="99.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anti-mumps ≥ 10 EU/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.6" lower_limit="97.7" upper_limit="99.2"/>
                    <measurement group_id="O2" value="98.6" lower_limit="97.6" upper_limit="99.2"/>
                    <measurement group_id="O3" value="98.0" lower_limit="96.9" 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>O2</group_id>
            </group_id_list>
            <groups_desc>Difference between groups (INV_MMR_L1 Group minus INV_MMR_L2 Group) in percentage of subjects with anti-mumps antibody concentration ≥10 EU/mL.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence (legacy)</non_inferiority_type>
            <non_inferiority_desc>For each pair-wise comparison, the 2-sided 95% CI on the lot difference in seroresponse rates should be within the [-5%;5%] margin for antibodies to mumps virus.</non_inferiority_desc>
            <param_type>Difference in seroresponse rate</param_type>
            <param_value>0.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.05</ci_lower_limit>
            <ci_upper_limit>1.09</ci_upper_limit>
            <estimate_desc>Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Difference between groups (INV_MMR_L1 Group minus INV_MMR_L3 Group) in percentage of subjects with anti-mumps antibody concentration ≥10 EU/mL.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence (legacy)</non_inferiority_type>
            <non_inferiority_desc>For each pair-wise comparison, the 2-sided 95% CI on the lot difference in seroresponse rates should be within the [-5%;5%] margin for antibodies to mumps virus.</non_inferiority_desc>
            <param_type>Difference in seroresponse rate</param_type>
            <param_value>0.63</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.50</ci_lower_limit>
            <ci_upper_limit>1.81</ci_upper_limit>
            <estimate_desc>Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Difference between groups (INV_MMR_L2 Group minus INV_MMR_L3 Group) in percentage of subjects with anti-mumps antibody concentration ≥10 EU/mL.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence (legacy)</non_inferiority_type>
            <non_inferiority_desc>For each pair-wise comparison, the 2-sided 95% CI on the lot difference in seroresponse rates should be within the [-5%;5%] margin for antibodies to mumps virus.</non_inferiority_desc>
            <param_type>Difference in seroresponse rate</param_type>
            <param_value>0.61</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.53</ci_lower_limit>
            <ci_upper_limit>1.79</ci_upper_limit>
            <estimate_desc>Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Anti-mumps Virus Antibody Concentration</title>
        <description>Antibody concentrations were expressed as GMCs in EU/mL. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.</description>
        <time_frame>At Day 42</time_frame>
        <population>ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination &amp; with pre &amp; post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample &amp; complied with post dose blood sample schedule</population>
        <group_list>
          <group group_id="O1">
            <title>INV_MMR_L1 Group</title>
            <description>Subjects received 1 dose of INV_MMR_L1 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. 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_L2 Group</title>
            <description>Subjects received 1 dose of INV_MMR_L2 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. 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>INV_MMR_L3 Group</title>
            <description>Subjects received 1 dose of INV_MMR_L3 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. 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 Concentration</title>
          <description>Antibody concentrations were expressed as GMCs in EU/mL. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.</description>
          <population>ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination &amp; with pre &amp; post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample &amp; complied with post dose blood sample schedule</population>
          <units>EU/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1062"/>
                <count group_id="O2" value="1047"/>
                <count group_id="O3" value="1078"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.7" lower_limit="68.3" upper_limit="75.2"/>
                    <measurement group_id="O2" value="76.9" lower_limit="73.2" upper_limit="80.8"/>
                    <measurement group_id="O3" value="69.0" lower_limit="65.5" upper_limit="72.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Adjusted GMC ratio (INV_MMR_L1 Group divided by INV_MMR_L2 Group) for antibodies to mumps virus at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence (legacy)</non_inferiority_type>
            <non_inferiority_desc>For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to mumps.</non_inferiority_desc>
            <param_type>Adjusted GMC ratio</param_type>
            <param_value>0.93</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.87</ci_lower_limit>
            <ci_upper_limit>1.00</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Adjusted GMC ratio (INV_MMR_L1 Group divided by INV_MMR_L3 Group) for antibodies to mumps virus at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence (legacy)</non_inferiority_type>
            <non_inferiority_desc>For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to mumps.</non_inferiority_desc>
            <param_type>Adjusted GMC ratio</param_type>
            <param_value>1.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.97</ci_lower_limit>
            <ci_upper_limit>1.11</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Adjusted GMC ratio (INV_MMR_L2 Group divided by INV_MMR_L1 Group) for antibodies to mumps virus at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence (legacy)</non_inferiority_type>
            <non_inferiority_desc>For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to mumps.</non_inferiority_desc>
            <param_type>Adjusted GMC ratio</param_type>
            <param_value>1.07</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.00</ci_lower_limit>
            <ci_upper_limit>1.15</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Adjusted GMC ratio (INV_MMR_L2 Group divided by INV_MMR_L3 Group) for antibodies to mumps virus at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence (legacy)</non_inferiority_type>
            <non_inferiority_desc>For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to mumps.</non_inferiority_desc>
            <param_type>Adjusted GMC ratio</param_type>
            <param_value>1.11</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.04</ci_lower_limit>
            <ci_upper_limit>1.19</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Adjusted GMC ratio (INV_MMR_L3 Group divided by INV_MMR_L1 Group) for antibodies to mumps virus at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence (legacy)</non_inferiority_type>
            <non_inferiority_desc>For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to mumps.</non_inferiority_desc>
            <param_type>Adjusted GMC ratio</param_type>
            <param_value>0.96</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.90</ci_lower_limit>
            <ci_upper_limit>1.03</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Adjusted GMC ratio (INV_MMR_L3 Group divided by INV_MMR_L2 Group) for antibodies to mumps virus at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence (legacy)</non_inferiority_type>
            <non_inferiority_desc>For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to mumps.</non_inferiority_desc>
            <param_type>Adjusted GMC ratio</param_type>
            <param_value>0.90</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.84</ci_lower_limit>
            <ci_upper_limit>0.96</ci_upper_limit>
          </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</title>
        <description>Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥10 International Unit/Milliliter (IU/mL) among subjects who were seronegative (antibody concentrations &lt;4 IU/mL) before vaccination. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.</description>
        <time_frame>At Day 42</time_frame>
        <population>ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination &amp; with pre &amp; post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample &amp; complied with post dose blood sample schedule</population>
        <group_list>
          <group group_id="O1">
            <title>INV_MMR_L1 Group</title>
            <description>Subjects received 1 dose of INV_MMR_L1 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. 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_L2 Group</title>
            <description>Subjects received 1 dose of INV_MMR_L2 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. 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>INV_MMR_L3 Group</title>
            <description>Subjects received 1 dose of INV_MMR_L3 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. 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</title>
          <description>Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥10 International Unit/Milliliter (IU/mL) among subjects who were seronegative (antibody concentrations &lt;4 IU/mL) before vaccination. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.</description>
          <population>ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination &amp; with pre &amp; post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample &amp; complied with post dose blood sample schedule</population>
          <units>Percentage of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1083"/>
                <count group_id="O2" value="1067"/>
                <count group_id="O3" value="1095"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Anti-rubella ≥ 4 IU/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.4" lower_limit="98.8" upper_limit="99.8"/>
                    <measurement group_id="O2" value="99.7" lower_limit="99.2" upper_limit="99.9"/>
                    <measurement group_id="O3" value="99.4" lower_limit="98.7" upper_limit="99.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anti-rubella ≥ 10 IU/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.2" lower_limit="96.1" upper_limit="98.1"/>
                    <measurement group_id="O2" value="97.1" lower_limit="95.9" upper_limit="98.0"/>
                    <measurement group_id="O3" value="97.7" lower_limit="96.6" upper_limit="98.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Difference between groups (INV_MMR_L1 Group minus INV_MMR_L2 Group) in percentage of subjects with anti-rubella antibody concentration ≥10 IU/mL.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence (legacy)</non_inferiority_type>
            <non_inferiority_desc>For each pair-wise comparison, the 2-sided 95% CI on the lot difference in seroresponse rates should be within the [-5%;5%] margin for antibodies to rubella virus.</non_inferiority_desc>
            <param_type>Difference in seroresponse rate</param_type>
            <param_value>0.14</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.3</ci_lower_limit>
            <ci_upper_limit>1.58</ci_upper_limit>
            <estimate_desc>Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Difference between groups (INV_MMR_L1 Group minus INV_MMR_L3 Group) in percentage of subjects with anti-rubella antibody concentration ≥10 IU/mL.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence (legacy)</non_inferiority_type>
            <non_inferiority_desc>For each pair-wise comparison, the 2-sided 95% CI on the lot difference in seroresponse rates should be within the [-5%;5%] margin for antibodies to rubella virus.</non_inferiority_desc>
            <param_type>Difference in seroresponse rate</param_type>
            <param_value>-0.49</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.86</ci_lower_limit>
            <ci_upper_limit>0.86</ci_upper_limit>
            <estimate_desc>Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Difference between groups (INV_MMR_L2 Group minus INV_MMR_L3 Group) in percentage of subjects with anti-rubella antibody concentration ≥10 IU/mL.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence (legacy)</non_inferiority_type>
            <non_inferiority_desc>For each pair-wise comparison, the 2-sided 95% CI on the lot difference in seroresponse rates should be within the [-5%;5%] margin for antibodies to rubella virus.</non_inferiority_desc>
            <param_type>Difference in seroresponse rate</param_type>
            <param_value>-0.62</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.02</ci_lower_limit>
            <ci_upper_limit>0.74</ci_upper_limit>
            <estimate_desc>Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Anti-rubella Virus Antibody Concentration</title>
        <description>Antibody concentrations were expressed as GMCs in IU/mL. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.</description>
        <time_frame>At Day 42</time_frame>
        <population>ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination &amp; with pre &amp; post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample &amp; complied with post dose blood sample schedule</population>
        <group_list>
          <group group_id="O1">
            <title>INV_MMR_L1 Group</title>
            <description>Subjects received 1 dose of INV_MMR_L1 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. 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_L2 Group</title>
            <description>Subjects received 1 dose of INV_MMR_L2 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. 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>INV_MMR_L3 Group</title>
            <description>Subjects received 1 dose of INV_MMR_L3 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. 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 Concentration</title>
          <description>Antibody concentrations were expressed as GMCs in IU/mL. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.</description>
          <population>ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination &amp; with pre &amp; post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample &amp; complied with post dose blood sample schedule</population>
          <units>IU/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1083"/>
                <count group_id="O2" value="1067"/>
                <count group_id="O3" value="1095"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.2" lower_limit="54.4" upper_limit="60.1"/>
                    <measurement group_id="O2" value="53.1" lower_limit="50.5" upper_limit="55.7"/>
                    <measurement group_id="O3" value="57.0" lower_limit="54.3" upper_limit="59.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Adjusted GMC ratio (INV_MMR_L1 Group divided by INV_MMR_L2 Group) for antibodies to rubella virus at Day 42.&#xD;
.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence (legacy)</non_inferiority_type>
            <non_inferiority_desc>For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to measles.</non_inferiority_desc>
            <param_type>Adjusted GMC ratio</param_type>
            <param_value>1.08</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.01</ci_lower_limit>
            <ci_upper_limit>1.15</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Adjusted GMC ratio (INV_MMR_L1 Group divided by INV_MMR_L3 Group) for antibodies to rubella virus at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence (legacy)</non_inferiority_type>
            <non_inferiority_desc>For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to measles.</non_inferiority_desc>
            <param_type>Adjusted GMC ratio</param_type>
            <param_value>1.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.94</ci_lower_limit>
            <ci_upper_limit>1.07</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Adjusted GMC ratio (INV_MMR_L2 Group divided by INV_MMR_L1 Group) for antibodies to rubella virus at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence (legacy)</non_inferiority_type>
            <non_inferiority_desc>For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to measles.</non_inferiority_desc>
            <param_type>Adjusted GMC ratio</param_type>
            <param_value>0.93</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.87</ci_lower_limit>
            <ci_upper_limit>0.99</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Adjusted GMC ratio (INV_MMR_L2 Group divided by INV_MMR_L3 Group) for antibodies to rubella virus at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence (legacy)</non_inferiority_type>
            <non_inferiority_desc>For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to measles.</non_inferiority_desc>
            <param_type>Adjusted GMC ratio</param_type>
            <param_value>0.93</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.87</ci_lower_limit>
            <ci_upper_limit>0.99</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Adjusted GMC ratio (INV_MMR_L3 Group divided by INV_MMR_L1 Group) for antibodies to rubella virus at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence (legacy)</non_inferiority_type>
            <non_inferiority_desc>For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to measles.</non_inferiority_desc>
            <param_type>Adjusted GMC ratio</param_type>
            <param_value>1.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.93</ci_lower_limit>
            <ci_upper_limit>1.07</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Adjusted GMC ratio (INV_MMR_L3 Group divided by INV_MMR_L2 Group) for antibodies to rubella virus at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence (legacy)</non_inferiority_type>
            <non_inferiority_desc>For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to measles.</non_inferiority_desc>
            <param_type>Adjusted GMC ratio</param_type>
            <param_value>1.08</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.01</ci_lower_limit>
            <ci_upper_limit>1.15</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups</title>
        <description>Seroresponse was defined as post-vaccination anti-measles virus antibody concentration ≥200 mIU/mL among subjects who were seronegative (antibody concentration &lt;150 mIU/mL) before vaccination. Criteria to demonstrate an acceptable immune response for INV_MMR in terms of seroresponse rates to measles virus at Day 42: The LL of 2-sided 95% CI for the seroresponse rate for the pooled INV_MMR lots is ≥90% for antibodies to measles virus.</description>
        <time_frame>At Day 42</time_frame>
        <population>ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination &amp; with pre &amp; post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample &amp; complied with post dose blood sample schedule</population>
        <group_list>
          <group group_id="O1">
            <title>INV_MMR Group</title>
            <description>This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.</description>
          </group>
          <group group_id="O2">
            <title>COM_MMR Group</title>
            <description>Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups</title>
          <description>Seroresponse was defined as post-vaccination anti-measles virus antibody concentration ≥200 mIU/mL among subjects who were seronegative (antibody concentration &lt;150 mIU/mL) before vaccination. Criteria to demonstrate an acceptable immune response for INV_MMR in terms of seroresponse rates to measles virus at Day 42: The LL of 2-sided 95% CI for the seroresponse rate for the pooled INV_MMR lots is ≥90% for antibodies to measles virus.</description>
          <population>ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination &amp; with pre &amp; post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample &amp; complied with post dose blood sample schedule</population>
          <units>Percentage of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3248"/>
                <count group_id="O2" value="1137"/>
              </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="98.4" lower_limit="97.9" upper_limit="98.8"/>
                    <measurement group_id="O2" value="98.1" lower_limit="97.1" upper_limit="98.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anti-measles ≥ 200 mIU/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.2" lower_limit="97.6" upper_limit="98.6"/>
                    <measurement group_id="O2" value="98.0" lower_limit="97.0" 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>O2</group_id>
            </group_id_list>
            <groups_desc>Difference in percentage (INV_MMR Group minus COM_MMR Group) of subjects with anti-measles antibody concentration at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The Lower Limit (LL) of 2-sided 95 % CI for the difference in seroresponse (INV_MMR Group minus COM_MMR Group) should be ≥-5% for antibodies to measles virus.</non_inferiority_desc>
            <param_type>Difference in seroresponse rate</param_type>
            <param_value>0.18</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.68</ci_lower_limit>
            <ci_upper_limit>1.25</ci_upper_limit>
            <estimate_desc>Asymptotic standardized 95% CIs for the difference in seroresponse rate.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Anti-measles Virus Antibody Concentrations in Pooled MMR Groups</title>
        <description>Antibody concentrations were expressed as GMCs in mIU/mL.</description>
        <time_frame>At Day 42</time_frame>
        <population>ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination &amp; with pre &amp; post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample &amp; complied with post dose blood sample schedule</population>
        <group_list>
          <group group_id="O1">
            <title>INV_MMR Group</title>
            <description>This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.</description>
          </group>
          <group group_id="O2">
            <title>COM_MMR Group</title>
            <description>Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Anti-measles Virus Antibody Concentrations in Pooled MMR Groups</title>
          <description>Antibody concentrations were expressed as GMCs in mIU/mL.</description>
          <population>ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination &amp; with pre &amp; post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample &amp; complied with post dose blood sample schedule</population>
          <units>mIU/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3248"/>
                <count group_id="O2" value="1137"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3017.4" lower_limit="2923.9" upper_limit="3113.8"/>
                    <measurement group_id="O2" value="3074.4" lower_limit="2911.0" upper_limit="3246.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for antibodies to measles virus at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The LL of the 2-sided 95% CI on GMC ratio (INV_MMR Group over COM_MMR Group) should be ≥0.67 for antibodies to measles virus.</non_inferiority_desc>
            <param_type>Adjusted GMC ratio</param_type>
            <param_value>0.98</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.93</ci_lower_limit>
            <ci_upper_limit>1.05</ci_upper_limit>
          </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 in Pooled MMR Groups</title>
        <description>Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥10 EU/mL among subjects who were seronegative (antibody concentrations &lt;5 EU/mL) before vaccination.</description>
        <time_frame>At Day 42</time_frame>
        <population>ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination &amp; with pre &amp; post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample &amp; complied with post dose blood sample schedule</population>
        <group_list>
          <group group_id="O1">
            <title>INV_MMR Group</title>
            <description>This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.</description>
          </group>
          <group group_id="O2">
            <title>COM_MMR Group</title>
            <description>Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups</title>
          <description>Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥10 EU/mL among subjects who were seronegative (antibody concentrations &lt;5 EU/mL) before vaccination.</description>
          <population>ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination &amp; with pre &amp; post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample &amp; complied with post dose blood sample schedule</population>
          <units>Percentage of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3187"/>
                <count group_id="O2" value="1107"/>
              </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="99.4" lower_limit="99.1" upper_limit="99.6"/>
                    <measurement group_id="O2" value="99.3" lower_limit="98.6" 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="98.4" lower_limit="97.9" upper_limit="98.8"/>
                    <measurement group_id="O2" value="97.6" lower_limit="96.5" upper_limit="98.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Difference in percentage (INV_MMR Group minus COM_MMR Group) of subjects with anti-mumps antibody concentration at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The LL of 2-sided 95 % CI for the difference in seroresponse (INV_MMR Group minus COM_MMR Group) should be ≥-5% for antibodies to mumps virus.</non_inferiority_desc>
            <param_type>Difference in seroresponse rate</param_type>
            <param_value>0.81</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.1</ci_lower_limit>
            <ci_upper_limit>1.96</ci_upper_limit>
            <estimate_desc>Asymptotic standardized 95% CIs for the difference in seroresponse rate.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Anti-mumps Virus Antibody Concentration in Pooled MMR Groups</title>
        <description>Antibody concentrations were expressed as GMCs in EU/mL.</description>
        <time_frame>At Day 42</time_frame>
        <population>ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination &amp; with pre &amp; post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample &amp; complied with post dose blood sample schedule</population>
        <group_list>
          <group group_id="O1">
            <title>INV_MMR Group</title>
            <description>This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.</description>
          </group>
          <group group_id="O2">
            <title>COM_MMR Group</title>
            <description>Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Anti-mumps Virus Antibody Concentration in Pooled MMR Groups</title>
          <description>Antibody concentrations were expressed as GMCs in EU/mL.</description>
          <population>ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination &amp; with pre &amp; post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample &amp; complied with post dose blood sample schedule</population>
          <units>EU/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3187"/>
                <count group_id="O2" value="1107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.4" lower_limit="70.4" upper_limit="74.5"/>
                    <measurement group_id="O2" value="69.1" lower_limit="65.7" upper_limit="72.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for antibodies to mumps virus at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The LL of the 2-sided 95% CI on GMC ratio (INV_MMR Group over COM_MMR Group) should be ≥0.67 for antibodies to mumps virus.</non_inferiority_desc>
            <param_type>Adjusted GMC ratio</param_type>
            <param_value>1.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.99</ci_lower_limit>
            <ci_upper_limit>1.11</ci_upper_limit>
          </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 in Pooled MMR Groups</title>
        <description>Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥10 IU/mL among subjects who were seronegative (antibody concentrations &lt;4 IU/mL) before vaccination. Criteria to demonstrate an acceptable immune response for INV_MMR in terms of seroresponse rates to rubella virus at Day 42: The LL of 2-sided 95% CI for the seroresponse rate for the pooled INV_MMR lots is ≥90% for antibodies to rubella virus.</description>
        <time_frame>At Day 42</time_frame>
        <population>ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination &amp; with pre &amp; post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample &amp; complied with post dose blood sample schedule</population>
        <group_list>
          <group group_id="O1">
            <title>INV_MMR Group</title>
            <description>This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.</description>
          </group>
          <group group_id="O2">
            <title>COM_MMR Group</title>
            <description>Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups</title>
          <description>Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥10 IU/mL among subjects who were seronegative (antibody concentrations &lt;4 IU/mL) before vaccination. Criteria to demonstrate an acceptable immune response for INV_MMR in terms of seroresponse rates to rubella virus at Day 42: The LL of 2-sided 95% CI for the seroresponse rate for the pooled INV_MMR lots is ≥90% for antibodies to rubella virus.</description>
          <population>ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination &amp; with pre &amp; post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample &amp; complied with post dose blood sample schedule</population>
          <units>Percentage of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3245"/>
                <count group_id="O2" value="1135"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Anti-rubella ≥ 4 IU/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.5" lower_limit="99.2" upper_limit="99.7"/>
                    <measurement group_id="O2" value="99.6" lower_limit="99.0" upper_limit="99.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anti-rubella ≥ 10 IU/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.3" lower_limit="96.7" upper_limit="97.9"/>
                    <measurement group_id="O2" 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>O2</group_id>
            </group_id_list>
            <groups_desc>Difference in percentage (INV_MMR Group minus COM_MMR Group) of subjects with anti-rubella antibody concentration at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The LL of 2-sided 95 % CI for the difference in seroresponse (INV_MMR Group minus COM_MMR Group) should be ≥-5% for antibodies to rubella virus.</non_inferiority_desc>
            <param_type>Difference in seroresponse rate</param_type>
            <param_value>-1.15</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.00</ci_lower_limit>
            <ci_upper_limit>-0.15</ci_upper_limit>
            <estimate_desc>Asymptotic standardized 95% CIs for the difference in seroresponse rate.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Anti-rubella Virus Antibody Concentration in Pooled MMR Groups</title>
        <description>Antibody concentrations were expressed as GMCs in IU/mL.</description>
        <time_frame>At Day 42</time_frame>
        <population>ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination &amp; with pre &amp; post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample &amp; complied with post dose blood sample schedule</population>
        <group_list>
          <group group_id="O1">
            <title>INV_MMR Group</title>
            <description>This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.</description>
          </group>
          <group group_id="O2">
            <title>COM_MMR Group</title>
            <description>Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Anti-rubella Virus Antibody Concentration in Pooled MMR Groups</title>
          <description>Antibody concentrations were expressed as GMCs in IU/mL.</description>
          <population>ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination &amp; with pre &amp; post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample &amp; complied with post dose blood sample schedule</population>
          <units>IU/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3245"/>
                <count group_id="O2" value="1135"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.7" lower_limit="54.2" upper_limit="57.3"/>
                    <measurement group_id="O2" value="64.0" lower_limit="61.1" upper_limit="67.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for antibodies to rubella virus at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The LL of the 2-sided 95% CI on GMC ratio (INV_MMR Group over COM_MMR Group) should be ≥0.67 for antibodies to measles virus.</non_inferiority_desc>
            <param_type>Adjusted GMC ratio</param_type>
            <param_value>0.87</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.83</ci_lower_limit>
            <ci_upper_limit>0.92</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects With an Anti-Varicella Zoster Virus (VZV) Antibody Concentration Equal to or Above the Cut-off Value in US Sub-cohort of Pooled MMR Groups</title>
        <description>Seroresponse was defined as post-vaccination anti-VZV antibody concentration ≥75 mIU/mL among subjects who were seronegative (antibody concentration &lt;25 mIU/mL) before vaccination.</description>
        <time_frame>At Day 42</time_frame>
        <population>ATP cohort for immunogenicity included subjects from US sub-cohort who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination &amp; with pre &amp; post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample &amp; complied with post dose blood sample schedule</population>
        <group_list>
          <group group_id="O1">
            <title>INV_MMR Group</title>
            <description>This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.</description>
          </group>
          <group group_id="O2">
            <title>COM_MMR Group</title>
            <description>Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects With an Anti-Varicella Zoster Virus (VZV) Antibody Concentration Equal to or Above the Cut-off Value in US Sub-cohort of Pooled MMR Groups</title>
          <description>Seroresponse was defined as post-vaccination anti-VZV antibody concentration ≥75 mIU/mL among subjects who were seronegative (antibody concentration &lt;25 mIU/mL) before vaccination.</description>
          <population>ATP cohort for immunogenicity included subjects from US sub-cohort who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination &amp; with pre &amp; post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample &amp; complied with post dose blood sample schedule</population>
          <units>Percentage of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1492"/>
                <count group_id="O2" value="540"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Anti-VZV ≥ 25 mIU/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.7" lower_limit="99.3" upper_limit="99.9"/>
                    <measurement group_id="O2" value="99.6" lower_limit="98.7" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anti-VZV ≥ 75 mIU/mL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.2" lower_limit="90.7" upper_limit="93.5"/>
                    <measurement group_id="O2" value="90.9" lower_limit="88.2" upper_limit="93.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>In US sub-cohort: Difference in percentage (INV_MMR Group minus COM_MMR Group) of subjects with anti-VZV antibody concentration at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The LL of 2-sided 95 % CI for the difference in seroresponse (pooled INV_MMR Group minus pooled COM_MMR Group) should be ≥-10% for antibodies to VZV.</non_inferiority_desc>
            <param_type>Difference in seroresponse rate</param_type>
            <param_value>1.30</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.31</ci_lower_limit>
            <ci_upper_limit>4.29</ci_upper_limit>
            <estimate_desc>Asymptotic standardized 95% CIs for the difference in seroresponse rate.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anti-VZV Virus Antibody Concentration in US Sub-cohort of Pooled MMR Groups</title>
        <description>Antibody concentrations were expressed as GMCs in mIU/mL.</description>
        <time_frame>At Day 42</time_frame>
        <population>ATP cohort for immunogenicity included subjects from US sub-cohort who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination &amp; with pre &amp; post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample &amp; complied with post dose blood sample schedule</population>
        <group_list>
          <group group_id="O1">
            <title>INV_MMR Group</title>
            <description>This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.</description>
          </group>
          <group group_id="O2">
            <title>COM_MMR Group</title>
            <description>Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Anti-VZV Virus Antibody Concentration in US Sub-cohort of Pooled MMR Groups</title>
          <description>Antibody concentrations were expressed as GMCs in mIU/mL.</description>
          <population>ATP cohort for immunogenicity included subjects from US sub-cohort who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination &amp; with pre &amp; post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample &amp; complied with post dose blood sample schedule</population>
          <units>mIU/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1492"/>
                <count group_id="O2" value="540"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="169.6" lower_limit="164.3" upper_limit="175"/>
                    <measurement group_id="O2" value="167.2" lower_limit="158.2" upper_limit="176.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>In US sub-cohort: Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for antibodies to VZV virus at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The LL of the 2-sided 95% CI on GMC ratio (INV_MMR Group over COM_MMR Group) should be ≥0.67 for antibodies to VZV.</non_inferiority_desc>
            <param_type>Adjusted GMC ratio</param_type>
            <param_value>1.01</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.95</ci_lower_limit>
            <ci_upper_limit>1.08</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects With an Anti-HAV Antibody Concentration Equal to or Above the Cut-off Value in US Sub-cohort of Pooled MMR Groups</title>
        <description>Percentage of subjects with an Anti-HAV antibody concentration equal to or above 15 mIU/mL were reported.</description>
        <time_frame>At Day 42</time_frame>
        <population>ATP cohort for immunogenicity included subjects from US sub-cohort who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination &amp; with pre &amp; post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample &amp; complied with post dose blood sample schedule</population>
        <group_list>
          <group group_id="O1">
            <title>INV_MMR Group</title>
            <description>This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.</description>
          </group>
          <group group_id="O2">
            <title>COM_MMR Group</title>
            <description>Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects With an Anti-HAV Antibody Concentration Equal to or Above the Cut-off Value in US Sub-cohort of Pooled MMR Groups</title>
          <description>Percentage of subjects with an Anti-HAV antibody concentration equal to or above 15 mIU/mL were reported.</description>
          <population>ATP cohort for immunogenicity included subjects from US sub-cohort who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination &amp; with pre &amp; post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample &amp; complied with post dose blood sample schedule</population>
          <units>Percentage of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="783"/>
                <count group_id="O2" value="285"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.9" lower_limit="86.5" upper_limit="91.0"/>
                    <measurement group_id="O2" value="87.4" lower_limit="82.9" upper_limit="91.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anti-HAV Antibody Concentrations in US Sub-cohort of Pooled MMR Groups</title>
        <description>Antibody concentrations were expressed as GMCs in mIU/mL.</description>
        <time_frame>At Day 42</time_frame>
        <population>ATP cohort for immunogenicity included subjects from US sub-cohort who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination &amp; with pre &amp; post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample &amp; complied with post dose blood sample schedule</population>
        <group_list>
          <group group_id="O1">
            <title>INV_MMR Group</title>
            <description>This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.</description>
          </group>
          <group group_id="O2">
            <title>COM_MMR Group</title>
            <description>Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Anti-HAV Antibody Concentrations in US Sub-cohort of Pooled MMR Groups</title>
          <description>Antibody concentrations were expressed as GMCs in mIU/mL.</description>
          <population>ATP cohort for immunogenicity included subjects from US sub-cohort who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination &amp; with pre &amp; post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample &amp; complied with post dose blood sample schedule</population>
          <units>mIU/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="783"/>
                <count group_id="O2" value="285"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.0" lower_limit="39.3" upper_limit="44.8"/>
                    <measurement group_id="O2" value="42.4" lower_limit="38.1" upper_limit="47.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>In US sub-cohort: Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for antibodies to HAV virus at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The LL of the 2-sided 95% CI on GMC ratio (INV_MMR Group over COM_MMR Group) was ≥0.5 for antibodies to HAV virus.</non_inferiority_desc>
            <param_type>Adjusted GMC ratio</param_type>
            <param_value>0.98</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.86</ci_lower_limit>
            <ci_upper_limit>1.11</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anti-S.Pneumoniae Antibody Concentration in US Sub-cohort of Pooled MMR Groups</title>
        <description>Antibody concentrations were expressed as GMCs in microgram/Milliliter (µg/mL).</description>
        <time_frame>At Day 42</time_frame>
        <population>ATP cohort for immunogenicity included subjects from US sub-cohort who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination &amp; with pre &amp; post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample &amp; complied with post dose blood sample schedule</population>
        <group_list>
          <group group_id="O1">
            <title>INV_MMR Group</title>
            <description>This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.</description>
          </group>
          <group group_id="O2">
            <title>COM_MMR Group</title>
            <description>Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Anti-S.Pneumoniae Antibody Concentration in US Sub-cohort of Pooled MMR Groups</title>
          <description>Antibody concentrations were expressed as GMCs in microgram/Milliliter (µg/mL).</description>
          <population>ATP cohort for immunogenicity included subjects from US sub-cohort who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination &amp; with pre &amp; post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample &amp; complied with post dose blood sample schedule</population>
          <units>µg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="759"/>
                <count group_id="O2" value="266"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>anti-PnPS 1 antibody</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="759"/>
                    <count group_id="O2" value="266"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.257" lower_limit="2.121" upper_limit="2.402"/>
                    <measurement group_id="O2" value="2.425" lower_limit="2.195" upper_limit="2.679"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>anti-PnPS 3 antibody</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="758"/>
                    <count group_id="O2" value="265"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.506" lower_limit="0.481" upper_limit="0.533"/>
                    <measurement group_id="O2" value="0.496" lower_limit="0.454" upper_limit="0.542"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>anti-PnPS 4 antibody</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="753"/>
                    <count group_id="O2" value="266"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.618" lower_limit="1.518" upper_limit="1.725"/>
                    <measurement group_id="O2" value="1.872" lower_limit="1.676" upper_limit="2.091"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>anti-PnPS 5 antibody</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="757"/>
                    <count group_id="O2" value="266"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.106" lower_limit="1.991" upper_limit="2.228"/>
                    <measurement group_id="O2" value="2.280" lower_limit="2.085" upper_limit="2.493"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>anti-PnPS 6A antibody</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="759"/>
                    <count group_id="O2" value="266"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.840" lower_limit="5.508" upper_limit="6.192"/>
                    <measurement group_id="O2" value="5.743" lower_limit="5.233" upper_limit="6.304"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>anti-PnPS 6B antibody</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="758"/>
                    <count group_id="O2" value="266"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.872" lower_limit="5.504" upper_limit="6.265"/>
                    <measurement group_id="O2" value="5.838" lower_limit="5.239" upper_limit="6.505"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>anti-PnPS 7F antibody</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="758"/>
                    <count group_id="O2" value="266"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.691" lower_limit="3.489" upper_limit="3.905"/>
                    <measurement group_id="O2" value="3.814" lower_limit="3.484" upper_limit="4.176"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>anti-PnPS 9V antibody</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="759"/>
                    <count group_id="O2" value="266"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.318" lower_limit="2.183" upper_limit="2.461"/>
                    <measurement group_id="O2" value="2.282" lower_limit="2.065" upper_limit="2.521"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>anti-PnPS 14 antibody</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="757"/>
                    <count group_id="O2" value="266"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.578" lower_limit="6.155" upper_limit="7.029"/>
                    <measurement group_id="O2" value="7.053" lower_limit="6.368" upper_limit="7.811"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>anti-PnPS 18C antibody</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="759"/>
                    <count group_id="O2" value="265"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.102" lower_limit="1.973" upper_limit="2.241"/>
                    <measurement group_id="O2" value="2.217" lower_limit="1.990" upper_limit="2.470"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>anti-PnPS 19A antibody</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="759"/>
                    <count group_id="O2" value="265"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.731" lower_limit="4.461" upper_limit="5.017"/>
                    <measurement group_id="O2" value="4.821" lower_limit="4.372" upper_limit="5.317"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>anti-PnPS 19F antibody</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="759"/>
                    <count group_id="O2" value="266"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.251" lower_limit="4.013" upper_limit="4.504"/>
                    <measurement group_id="O2" value="4.260" lower_limit="3.872" upper_limit="4.687"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>anti-PnPS 23F antibody</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="742"/>
                    <count group_id="O2" value="256"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.198" lower_limit="2.051" upper_limit="2.355"/>
                    <measurement group_id="O2" value="2.291" lower_limit="2.025" upper_limit="2.592"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>In US sub-cohort: Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for anti-PnPS 1 antibody at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The LL of the 2-sided 95% CI for GMC ratio (INV_MMR Group over COM_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.</non_inferiority_desc>
            <param_type>Adjusted GMC ratio</param_type>
            <param_value>0.94</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.85</ci_lower_limit>
            <ci_upper_limit>1.05</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>In US sub-cohort: Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for anti-PnPS 3 antibody at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The LL of the 2-sided 95% CI for GMC ratio (INV_MMR Group over COM_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.</non_inferiority_desc>
            <param_type>Adjusted GMC ratio</param_type>
            <param_value>0.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.91</ci_lower_limit>
            <ci_upper_limit>1.08</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>In US sub-cohort: Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for anti-PnPS 4 antibody at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The LL of the 2-sided 95% CI for GMC ratio (INV_MMR Group over COM_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.</non_inferiority_desc>
            <param_type>Adjusted GMC ratio</param_type>
            <param_value>0.88</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>0.79</ci_lower_limit>
            <ci_upper_limit>0.98</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>In US sub-cohort: Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for anti-PnPS 5 antibody at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The LL of the 2-sided 95% CI for GMC ratio (INV_MMR Group over COM_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.</non_inferiority_desc>
            <param_type>Adjusted GMC ratio</param_type>
            <param_value>0.92</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.83</ci_lower_limit>
            <ci_upper_limit>1.01</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>In US sub-cohort: Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for anti-PnPS 6A antibody at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The LL of the 2-sided 95% CI for GMC ratio (INV_MMR Group over COM_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.</non_inferiority_desc>
            <param_type>Adjusted GMC ratio</param_type>
            <param_value>1.01</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.92</ci_lower_limit>
            <ci_upper_limit>1.11</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>In US sub-cohort: Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for anti-PnPS 6B antibody at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The LL of the 2-sided 95% CI for GMC ratio (INV_MMR Group over COM_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.</non_inferiority_desc>
            <param_type>Adjusted GMC ratio</param_type>
            <param_value>0.98</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.89</ci_lower_limit>
            <ci_upper_limit>1.09</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>In US sub-cohort: Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for anti-PnPS 7F antibody at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The LL of the 2-sided 95% CI for GMC ratio (INV_MMR Group over COM_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.</non_inferiority_desc>
            <param_type>Adjusted GMC ratio</param_type>
            <param_value>0.94</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.86</ci_lower_limit>
            <ci_upper_limit>1.03</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>In US sub-cohort: Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for anti-PnPS 9V antibody at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The LL of the 2-sided 95% CI for GMC ratio (INV_MMR Group over COM_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.</non_inferiority_desc>
            <param_type>Adjusted GMC ratio</param_type>
            <param_value>0.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.90</ci_lower_limit>
            <ci_upper_limit>1.08</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>In US sub-cohort: Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for anti-PnPS 14 antibody at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The LL of the 2-sided 95% CI for GMC ratio (INV_MMR Group over COM_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.</non_inferiority_desc>
            <param_type>Adjusted GMC ratio</param_type>
            <param_value>0.91</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.81</ci_lower_limit>
            <ci_upper_limit>1.02</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>In US sub-cohort: Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for anti-PnPS 18C antibody at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The LL of the 2-sided 95% CI for GMC ratio (INV_MMR Group over COM_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.</non_inferiority_desc>
            <param_type>Adjusted GMC ratio</param_type>
            <param_value>0.92</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.84</ci_lower_limit>
            <ci_upper_limit>1.02</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>In US sub-cohort: Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for anti-PnPS 19A antibody at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The LL of the 2-sided 95% CI for GMC ratio (INV_MMR Group over COM_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.</non_inferiority_desc>
            <param_type>Adjusted GMC ratio</param_type>
            <param_value>0.97</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.87</ci_lower_limit>
            <ci_upper_limit>1.07</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>In US sub-cohort: Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for anti-PnPS 19F antibody at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The LL of the 2-sided 95% CI for GMC ratio (INV_MMR Group over COM_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.</non_inferiority_desc>
            <param_type>Adjusted GMC ratio</param_type>
            <param_value>0.96</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.87</ci_lower_limit>
            <ci_upper_limit>1.06</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>In US sub-cohort: Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for anti-PnPS 23F antibody at Day 42.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The LL of the 2-sided 95% CI for GMC ratio (INV_MMR Group over COM_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.</non_inferiority_desc>
            <param_type>Adjusted GMC ratio</param_type>
            <param_value>0.95</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.85</ci_lower_limit>
            <ci_upper_limit>1.06</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Any Solicited Local Adverse Events (AEs)</title>
        <description>Assessed solicited local AEs were pain, redness and swelling. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.</description>
        <time_frame>During the 4-days (Days 0-3) post-vaccination period</time_frame>
        <population>Total Vaccinated cohort (TVC) included all subjects with at least one vaccine administration of either INV_MMR or COM_MMR lots documented</population>
        <group_list>
          <group group_id="O1">
            <title>INV_MMR_L1 Group</title>
            <description>Subjects received 1 dose of INV_MMR_L1 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. 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_L2 Group</title>
            <description>Subjects received 1 dose of INV_MMR_L2 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. 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>INV_MMR_L3 Group</title>
            <description>Subjects received 1 dose of INV_MMR_L3 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O4">
            <title>INV_MMR Group</title>
            <description>This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.</description>
          </group>
          <group group_id="O5">
            <title>COM_MMR Group</title>
            <description>Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Any Solicited Local Adverse Events (AEs)</title>
          <description>Assessed solicited local AEs were pain, redness and swelling. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.</description>
          <population>Total Vaccinated cohort (TVC) included all subjects with at least one vaccine administration of either INV_MMR 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="1186"/>
                <count group_id="O2" value="1175"/>
                <count group_id="O3" value="1194"/>
                <count group_id="O4" value="3555"/>
                <count group_id="O5" value="1242"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="331"/>
                    <measurement group_id="O2" value="315"/>
                    <measurement group_id="O3" value="273"/>
                    <measurement group_id="O4" value="919"/>
                    <measurement group_id="O5" value="349"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Redness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="296"/>
                    <measurement group_id="O2" value="273"/>
                    <measurement group_id="O3" value="301"/>
                    <measurement group_id="O4" value="870"/>
                    <measurement group_id="O5" value="313"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Swelling</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="116"/>
                    <measurement group_id="O2" value="99"/>
                    <measurement group_id="O3" value="103"/>
                    <measurement group_id="O4" value="318"/>
                    <measurement group_id="O5" value="133"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Any Solicited General AEs</title>
        <description>Assessed solicited general AEs were drowsiness, irritability and loss of appetite. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.</description>
        <time_frame>During the 15-days (Days 0-14) post-vaccination period</time_frame>
        <population>TVC included all subjects with at least one vaccine administration of either INV_MMR or COM_MMR lots documented</population>
        <group_list>
          <group group_id="O1">
            <title>INV_MMR_L1 Group</title>
            <description>Subjects received 1 dose of INV_MMR_L1 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. 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_L2 Group</title>
            <description>Subjects received 1 dose of INV_MMR_L2 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. 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>INV_MMR_L3 Group</title>
            <description>Subjects received 1 dose of INV_MMR_L3 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O4">
            <title>INV_MMR Group</title>
            <description>This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.</description>
          </group>
          <group group_id="O5">
            <title>COM_MMR Group</title>
            <description>Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Any Solicited General AEs</title>
          <description>Assessed solicited general AEs were drowsiness, irritability and loss of appetite. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.</description>
          <population>TVC included all subjects with at least one vaccine administration of either INV_MMR 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="1190"/>
                <count group_id="O2" value="1176"/>
                <count group_id="O3" value="1200"/>
                <count group_id="O4" value="3566"/>
                <count group_id="O5" value="1243"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any Drowsiness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="533"/>
                    <measurement group_id="O2" value="535"/>
                    <measurement group_id="O3" value="533"/>
                    <measurement group_id="O4" value="1601"/>
                    <measurement group_id="O5" value="586"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Irritability/fussiness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="764"/>
                    <measurement group_id="O2" value="729"/>
                    <measurement group_id="O3" value="765"/>
                    <measurement group_id="O4" value="2258"/>
                    <measurement group_id="O5" value="819"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Loss of appetite</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="546"/>
                    <measurement group_id="O2" value="536"/>
                    <measurement group_id="O3" value="526"/>
                    <measurement group_id="O4" value="1608"/>
                    <measurement group_id="O5" value="548"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting Any Fever</title>
        <description>Any fever = Fever ≥ 38°C.</description>
        <time_frame>During the 43-days (Days 0-42) post-vaccination period</time_frame>
        <population>TVC included all subjects with at least one vaccine administration of either INV_MMR or COM_MMR lots documented</population>
        <group_list>
          <group group_id="O1">
            <title>INV_MMR_L1 Group</title>
            <description>Subjects received 1 dose of INV_MMR_L1 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. 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_L2 Group</title>
            <description>Subjects received 1 dose of INV_MMR_L2 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. 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>INV_MMR_L3 Group</title>
            <description>Subjects received 1 dose of INV_MMR_L3 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O4">
            <title>INV_MMR Group</title>
            <description>This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.</description>
          </group>
          <group group_id="O5">
            <title>COM_MMR Group</title>
            <description>Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Any Fever</title>
          <description>Any fever = Fever ≥ 38°C.</description>
          <population>TVC included all subjects with at least one vaccine administration of either INV_MMR 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="1190"/>
                <count group_id="O2" value="1176"/>
                <count group_id="O3" value="1200"/>
                <count group_id="O4" value="3566"/>
                <count group_id="O5" value="1243"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="404"/>
                    <measurement group_id="O2" value="422"/>
                    <measurement group_id="O3" value="418"/>
                    <measurement group_id="O4" value="1244"/>
                    <measurement group_id="O5" value="412"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting Any Rash</title>
        <description>Assessed were any localized or generalized rash, rash with fever, varicella-like rash, measles/rubella-like rash. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.</description>
        <time_frame>During the 43-days (Days 0-42) post-vaccination period</time_frame>
        <population>TVC included all subjects with at least one vaccine administration of either INV_MMR or COM_MMR lots documented</population>
        <group_list>
          <group group_id="O1">
            <title>INV_MMR_L1 Group</title>
            <description>Subjects received 1 dose of INV_MMR_L1 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. 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_L2 Group</title>
            <description>Subjects received 1 dose of INV_MMR_L2 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. 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>INV_MMR_L3 Group</title>
            <description>Subjects received 1 dose of INV_MMR_L3 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O4">
            <title>INV_MMR Group</title>
            <description>This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.</description>
          </group>
          <group group_id="O5">
            <title>COM_MMR Group</title>
            <description>Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Any Rash</title>
          <description>Assessed were any localized or generalized rash, rash with fever, varicella-like rash, measles/rubella-like rash. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.</description>
          <population>TVC included all subjects with at least one vaccine administration of either INV_MMR 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="1190"/>
                <count group_id="O2" value="1176"/>
                <count group_id="O3" value="1200"/>
                <count group_id="O4" value="3566"/>
                <count group_id="O5" value="1243"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any Localized or Generalized</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="352"/>
                    <measurement group_id="O2" value="331"/>
                    <measurement group_id="O3" value="360"/>
                    <measurement group_id="O4" value="1043"/>
                    <measurement group_id="O5" value="378"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any with fever</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="106"/>
                    <measurement group_id="O2" value="123"/>
                    <measurement group_id="O3" value="118"/>
                    <measurement group_id="O4" value="347"/>
                    <measurement group_id="O5" value="104"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Varicella like</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87"/>
                    <measurement group_id="O2" value="78"/>
                    <measurement group_id="O3" value="85"/>
                    <measurement group_id="O4" value="250"/>
                    <measurement group_id="O5" value="85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Measles/Rubella like</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71"/>
                    <measurement group_id="O2" value="88"/>
                    <measurement group_id="O3" value="76"/>
                    <measurement group_id="O4" value="235"/>
                    <measurement group_id="O5" value="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting Any MMR Specific Solicited AEs</title>
        <description>Assessed MMR specific solicited AEs were any suspected signs of meningism including febrile convulsions and parotid/salivary gland swelling. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.</description>
        <time_frame>During the 43-days (Days 0-42) post-vaccination period</time_frame>
        <population>TVC included all subjects with at least one vaccine administration of either INV_MMR or COM_MMR lots documented</population>
        <group_list>
          <group group_id="O1">
            <title>INV_MMR_L1 Group</title>
            <description>Subjects received 1 dose of INV_MMR_L1 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. 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_L2 Group</title>
            <description>Subjects received 1 dose of INV_MMR_L2 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. 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>INV_MMR_L3 Group</title>
            <description>Subjects received 1 dose of INV_MMR_L3 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O4">
            <title>INV_MMR Group</title>
            <description>This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.</description>
          </group>
          <group group_id="O5">
            <title>COM_MMR Group</title>
            <description>Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Any MMR Specific Solicited AEs</title>
          <description>Assessed MMR specific solicited AEs were any suspected signs of meningism including febrile convulsions and parotid/salivary gland swelling. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.</description>
          <population>TVC included all subjects with at least one vaccine administration of either INV_MMR 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="1190"/>
                <count group_id="O2" value="1176"/>
                <count group_id="O3" value="1200"/>
                <count group_id="O4" value="3566"/>
                <count group_id="O5" value="1243"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any febrile convulsion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="10"/>
                    <measurement group_id="O5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any parotid/salivary gland swelling</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting Any Unsolicited AEs</title>
        <description>Unsolicited adverse event (AE) was defined as any adverse event reported in addition to those solicited during the clinical study and also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.</description>
        <time_frame>During the 43-days (Days 0-42) post-vaccination period</time_frame>
        <population>TVC included all subjects with at least one vaccine administration of either INV_MMR or COM_MMR lots documented</population>
        <group_list>
          <group group_id="O1">
            <title>INV_MMR_L1 Group</title>
            <description>Subjects received 1 dose of INV_MMR_L1 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. 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_L2 Group</title>
            <description>Subjects received 1 dose of INV_MMR_L2 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. 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>INV_MMR_L3 Group</title>
            <description>Subjects received 1 dose of INV_MMR_L3 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O4">
            <title>INV_MMR Group</title>
            <description>This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.</description>
          </group>
          <group group_id="O5">
            <title>COM_MMR Group</title>
            <description>Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Any Unsolicited AEs</title>
          <description>Unsolicited adverse event (AE) was defined as any adverse event reported in addition to those solicited during the clinical study and also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.</description>
          <population>TVC included all subjects with at least one vaccine administration of either INV_MMR 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="1239"/>
                <count group_id="O2" value="1232"/>
                <count group_id="O3" value="1243"/>
                <count group_id="O4" value="3714"/>
                <count group_id="O5" value="1289"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="615"/>
                    <measurement group_id="O2" value="633"/>
                    <measurement group_id="O3" value="609"/>
                    <measurement group_id="O4" value="1857"/>
                    <measurement group_id="O5" value="618"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting AEs of Specific Interest</title>
        <description>AEs of specific interest included new onset chronic disease (NOCD) (e.g., autoimmune disorders, asthma, type I diabetes, vasculitis, celiac disease, conditions associated with sub-acute or chronic thrombocytopenia and allergies) and AEs prompting emergency room (ER) visits.</description>
        <time_frame>From Day 0 through the end of study (Day 180)</time_frame>
        <population>TVC included all subjects with at least one vaccine administration of either INV_MMR or COM_MMR lots documented</population>
        <group_list>
          <group group_id="O1">
            <title>INV_MMR_L1 Group</title>
            <description>Subjects received 1 dose of INV_MMR_L1 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. 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_L2 Group</title>
            <description>Subjects received 1 dose of INV_MMR_L2 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. 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>INV_MMR_L3 Group</title>
            <description>Subjects received 1 dose of INV_MMR_L3 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O4">
            <title>INV_MMR Group</title>
            <description>This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.</description>
          </group>
          <group group_id="O5">
            <title>COM_MMR Group</title>
            <description>Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting AEs of Specific Interest</title>
          <description>AEs of specific interest included new onset chronic disease (NOCD) (e.g., autoimmune disorders, asthma, type I diabetes, vasculitis, celiac disease, conditions associated with sub-acute or chronic thrombocytopenia and allergies) and AEs prompting emergency room (ER) visits.</description>
          <population>TVC included all subjects with at least one vaccine administration of either INV_MMR 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="1239"/>
                <count group_id="O2" value="1232"/>
                <count group_id="O3" value="1243"/>
                <count group_id="O4" value="3714"/>
                <count group_id="O5" value="1289"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>NOCDs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="39"/>
                    <measurement group_id="O3" value="49"/>
                    <measurement group_id="O4" value="128"/>
                    <measurement group_id="O5" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AEs prompting ER visits</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="123"/>
                    <measurement group_id="O2" value="116"/>
                    <measurement group_id="O3" value="136"/>
                    <measurement group_id="O4" value="375"/>
                    <measurement group_id="O5" value="134"/>
                  </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 medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity. Any SAE = Occurrence of SAE regardless of intensity grade or relation to vaccination.</description>
        <time_frame>From Day 0 through the end of study (Day 180)</time_frame>
        <population>TVC included all subjects with at least one vaccine administration of either INV_MMR or COM_MMR lots documented</population>
        <group_list>
          <group group_id="O1">
            <title>INV_MMR_L1 Group</title>
            <description>Subjects received 1 dose of INV_MMR_L1 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. 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_L2 Group</title>
            <description>Subjects received 1 dose of INV_MMR_L2 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. 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>INV_MMR_L3 Group</title>
            <description>Subjects received 1 dose of INV_MMR_L3 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
          </group>
          <group group_id="O4">
            <title>INV_MMR Group</title>
            <description>This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.</description>
          </group>
          <group group_id="O5">
            <title>COM_MMR Group</title>
            <description>Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Any Serious Adverse Events (SAEs)</title>
          <description>SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity. Any SAE = Occurrence of SAE regardless of intensity grade or relation to vaccination.</description>
          <population>TVC included all subjects with at least one vaccine administration of either INV_MMR 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="1239"/>
                <count group_id="O2" value="1232"/>
                <count group_id="O3" value="1243"/>
                <count group_id="O4" value="3714"/>
                <count group_id="O5" value="1289"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="28"/>
                    <measurement group_id="O3" value="28"/>
                    <measurement group_id="O4" value="77"/>
                    <measurement group_id="O5" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Serious Adverse Events: From Day 0 through the end of study (Day-180); Solicited local and general symptoms: During the 4-day (Day 0-3) and 15-days (Day 0-14) post-vaccination period; Unsolicited adverse events: During the 43-days (Day 0-42) post-vaccination period.</time_frame>
      <desc>The analysis of the solicited symptoms was based on the Total Vaccinated cohort which included only children/doses with documented safety data (i.e., symptom screen/sheet completed).</desc>
      <group_list>
        <group group_id="E1">
          <title>INV_MMR_L1 Group</title>
          <description>Subjects received 1 dose of INV_MMR_L1 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. 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_L2 Group</title>
          <description>Subjects received 1 dose of INV_MMR_L2 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. 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>INV_MMR_L3 Group</title>
          <description>Subjects received 1 dose of INV_MMR_L3 vaccine co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.</description>
        </group>
        <group group_id="E4">
          <title>INV_MMR Group</title>
          <description>This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.</description>
        </group>
        <group group_id="E5">
          <title>COM_MMR Group</title>
          <description>Subjects received 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects were also given PCV-13 vaccine. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis was conducted for this group.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 20.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3714"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="1239"/>
                <counts group_id="E2" subjects_affected="28" subjects_at_risk="1232"/>
                <counts group_id="E3" subjects_affected="28" subjects_at_risk="1243"/>
                <counts group_id="E4" subjects_affected="77" subjects_at_risk="3714"/>
                <counts group_id="E5" subjects_affected="25" subjects_at_risk="1289"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="1289"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Enterocolitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Milk allergy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </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="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Bronchiolitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="3714"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="1239"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1232"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="1243"/>
                <counts group_id="E4" events="8" subjects_affected="8" subjects_at_risk="3714"/>
                <counts group_id="E5" events="3" subjects_affected="2" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1243"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Croup infectious</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Escherichia urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1243"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="3714"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Gastroenteritis adenovirus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Gastroenteritis rotavirus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Herpangina</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Laryngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Mycoplasma infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Neutropenic infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="1243"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="3714"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Otitis media acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Pneumococcal sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="1243"/>
                <counts group_id="E4" events="6" subjects_affected="6" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Pneumonia bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Pneumonia respiratory syncytial viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Pneumonia viral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Pyelonephritis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Respiratory syncytial virus bronchiolitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Rotavirus infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Subcutaneous abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1243"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="3714"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Viral pharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Burns second degree</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Concussion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Foot fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Head injury</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1232"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="1243"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="3714"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Type 1 diabetes mellitus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Febrile convulsion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="5" subjects_affected="5" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Loss of consciousness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1243"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </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="2" subjects_at_risk="1239"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="3714"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Bronchial hyperreactivity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="3714"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3714"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="1289"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Finger amputation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 20.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1089" subjects_at_risk="1239"/>
                <counts group_id="E2" subjects_affected="1053" subjects_at_risk="1232"/>
                <counts group_id="E3" subjects_affected="1090" subjects_at_risk="1243"/>
                <counts group_id="E4" subjects_affected="3232" subjects_at_risk="3714"/>
                <counts group_id="E5" subjects_affected="1138" subjects_at_risk="1289"/>
              </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="1239"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1232"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="1243"/>
                <counts group_id="E4" events="6" subjects_affected="6" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Iron deficiency anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Lymphadenitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="1239"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="1232"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1243"/>
                <counts group_id="E4" events="12" subjects_affected="12" subjects_at_risk="3714"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="1289"/>
              </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="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Deafness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="1239"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="1232"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="1243"/>
                <counts group_id="E4" events="10" subjects_affected="10" subjects_at_risk="3714"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Ear swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Eustachian tube dysfunction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Excessive cerumen production</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Otorrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctivitis allergic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Dacryostenosis acquired</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Eye discharge</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Eye inflammation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Eye irritation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Eye swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Eyelid oedema</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Hypermetropia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Lacrimation increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Lid sulcus deepened</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Strabismus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </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="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="6" subjects_affected="4" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Anal fissure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Aphthous ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3714"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Chapped lips</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="1239"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1232"/>
                <counts group_id="E3" events="9" subjects_affected="9" subjects_at_risk="1243"/>
                <counts group_id="E4" events="16" subjects_affected="16" subjects_at_risk="3714"/>
                <counts group_id="E5" events="8" subjects_affected="8" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="71" subjects_affected="64" subjects_at_risk="1239"/>
                <counts group_id="E2" events="63" subjects_affected="58" subjects_at_risk="1232"/>
                <counts group_id="E3" events="55" subjects_affected="49" subjects_at_risk="1243"/>
                <counts group_id="E4" events="189" subjects_affected="171" subjects_at_risk="3714"/>
                <counts group_id="E5" events="68" subjects_affected="64" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3714"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Faeces soft</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1239"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="3714"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Gingival hypertrophy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Gingival pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Gingival swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Lip swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Oral contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3714"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Oral mucosal eruption</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Post-tussive vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Ranula</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Regurgitation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3714"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Salivary gland enlargement</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Salivary gland pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Salivary hypersecretion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Teething</sub_title>
                <counts group_id="E1" events="114" subjects_affected="91" subjects_at_risk="1239"/>
                <counts group_id="E2" events="106" subjects_affected="92" subjects_at_risk="1232"/>
                <counts group_id="E3" events="92" subjects_affected="77" subjects_at_risk="1243"/>
                <counts group_id="E4" events="312" subjects_affected="260" subjects_at_risk="3714"/>
                <counts group_id="E5" events="114" subjects_affected="95" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" events="6" subjects_affected="4" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="7" subjects_affected="5" subjects_at_risk="3714"/>
                <counts group_id="E5" events="7" subjects_affected="6" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="39" subjects_affected="38" subjects_at_risk="1239"/>
                <counts group_id="E2" events="38" subjects_affected="35" subjects_at_risk="1232"/>
                <counts group_id="E3" events="38" subjects_affected="34" subjects_at_risk="1243"/>
                <counts group_id="E4" events="115" subjects_affected="107" subjects_at_risk="3714"/>
                <counts group_id="E5" events="46" subjects_affected="43" subjects_at_risk="1289"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Crying</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="1239"/>
                <counts group_id="E2" events="7" subjects_affected="5" subjects_at_risk="1232"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1243"/>
                <counts group_id="E4" events="13" subjects_affected="11" subjects_at_risk="3714"/>
                <counts group_id="E5" events="5" subjects_affected="4" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Cyst</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Feeling hot</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Injection site bruising</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="1239"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="10" subjects_affected="10" subjects_at_risk="3714"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Injection site erosion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" events="331" subjects_affected="321" subjects_at_risk="1239"/>
                <counts group_id="E2" events="303" subjects_affected="294" subjects_at_risk="1232"/>
                <counts group_id="E3" events="334" subjects_affected="328" subjects_at_risk="1243"/>
                <counts group_id="E4" events="968" subjects_affected="943" subjects_at_risk="3714"/>
                <counts group_id="E5" events="341" subjects_affected="335" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Injection site haematoma</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="1243"/>
                <counts group_id="E4" events="10" subjects_affected="9" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Injection site haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="3714"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Injection site induration</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="1239"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="1232"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1243"/>
                <counts group_id="E4" events="8" subjects_affected="8" subjects_at_risk="3714"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Injection site mass</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Injection site nodule</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" events="336" subjects_affected="335" subjects_at_risk="1239"/>
                <counts group_id="E2" events="317" subjects_affected="316" subjects_at_risk="1232"/>
                <counts group_id="E3" events="277" subjects_affected="275" subjects_at_risk="1243"/>
                <counts group_id="E4" events="930" subjects_affected="926" subjects_at_risk="3714"/>
                <counts group_id="E5" events="352" subjects_affected="352" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Injection site papule</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1239"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="3714"/>
                <counts group_id="E5" events="5" subjects_affected="5" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Injection site swelling</sub_title>
                <counts group_id="E1" events="128" subjects_affected="127" subjects_at_risk="1239"/>
                <counts group_id="E2" events="107" subjects_affected="106" subjects_at_risk="1232"/>
                <counts group_id="E3" events="115" subjects_affected="113" subjects_at_risk="1243"/>
                <counts group_id="E4" events="350" subjects_affected="346" subjects_at_risk="3714"/>
                <counts group_id="E5" events="142" subjects_affected="139" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Injection site vesicles</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="3714"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="406" subjects_affected="405" subjects_at_risk="1239"/>
                <counts group_id="E2" events="423" subjects_affected="422" subjects_at_risk="1232"/>
                <counts group_id="E3" events="419" subjects_affected="419" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1248" subjects_affected="1246" subjects_at_risk="3714"/>
                <counts group_id="E5" events="412" subjects_affected="412" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Secretion discharge</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Vessel puncture site haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </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="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Drug hypersensitivity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1243"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Food allergy</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1239"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1232"/>
                <counts group_id="E3" events="6" subjects_affected="5" subjects_at_risk="1243"/>
                <counts group_id="E4" events="10" subjects_affected="9" subjects_at_risk="3714"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="3714"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Immunisation reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Milk allergy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1239"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abscess limb</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Acute sinusitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Adenovirus infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Beta haemolytic streptococcal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Body tinea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Bronchiolitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1239"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="1232"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="1243"/>
                <counts group_id="E4" events="16" subjects_affected="16" subjects_at_risk="3714"/>
                <counts group_id="E5" events="6" subjects_affected="6" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="1239"/>
                <counts group_id="E2" events="13" subjects_affected="12" subjects_at_risk="1232"/>
                <counts group_id="E3" events="11" subjects_affected="10" subjects_at_risk="1243"/>
                <counts group_id="E4" events="34" subjects_affected="32" subjects_at_risk="3714"/>
                <counts group_id="E5" events="13" subjects_affected="12" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Bullous impetigo</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Candida infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="5" subjects_affected="4" subjects_at_risk="3714"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Candida nappy rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="1243"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Clostridium difficile infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" events="26" subjects_affected="26" subjects_at_risk="1239"/>
                <counts group_id="E2" events="21" subjects_affected="21" subjects_at_risk="1232"/>
                <counts group_id="E3" events="41" subjects_affected="39" subjects_at_risk="1243"/>
                <counts group_id="E4" events="88" subjects_affected="86" subjects_at_risk="3714"/>
                <counts group_id="E5" events="33" subjects_affected="32" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Conjunctivitis bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Coxsackie viral infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Croup infectious</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="1239"/>
                <counts group_id="E2" events="11" subjects_affected="11" subjects_at_risk="1232"/>
                <counts group_id="E3" events="8" subjects_affected="8" subjects_at_risk="1243"/>
                <counts group_id="E4" events="23" subjects_affected="23" subjects_at_risk="3714"/>
                <counts group_id="E5" events="6" subjects_affected="6" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="1239"/>
                <counts group_id="E2" events="14" subjects_affected="14" subjects_at_risk="1232"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="1243"/>
                <counts group_id="E4" events="27" subjects_affected="27" subjects_at_risk="3714"/>
                <counts group_id="E5" events="13" subjects_affected="13" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Enterovirus infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="3714"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Epstein-barr virus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Exanthema subitum</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3714"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Eye infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="3714"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Fungal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="28" subjects_affected="27" subjects_at_risk="1239"/>
                <counts group_id="E2" events="21" subjects_affected="21" subjects_at_risk="1232"/>
                <counts group_id="E3" events="38" subjects_affected="35" subjects_at_risk="1243"/>
                <counts group_id="E4" events="87" subjects_affected="83" subjects_at_risk="3714"/>
                <counts group_id="E5" events="32" subjects_affected="31" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Gastroenteritis norovirus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Gastroenteritis rotavirus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="1239"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="1232"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="1243"/>
                <counts group_id="E4" events="15" subjects_affected="15" subjects_at_risk="3714"/>
                <counts group_id="E5" events="6" subjects_affected="6" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Gastrointestinal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Gingivitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Hand-foot-and-mouth disease</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1239"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="1232"/>
                <counts group_id="E3" events="9" subjects_affected="9" subjects_at_risk="1243"/>
                <counts group_id="E4" events="14" subjects_affected="14" subjects_at_risk="3714"/>
                <counts group_id="E5" events="5" subjects_affected="5" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Herpangina</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="3714"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Herpes simplex</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Hordeolum</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Impetigo</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="6" subjects_affected="6" subjects_at_risk="3714"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Infected bite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1239"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="8" subjects_affected="8" subjects_at_risk="3714"/>
                <counts group_id="E5" events="12" subjects_affected="10" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Injection site abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Laryngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="9" subjects_affected="7" subjects_at_risk="1232"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1243"/>
                <counts group_id="E4" events="12" subjects_affected="10" subjects_at_risk="3714"/>
                <counts group_id="E5" events="6" subjects_affected="6" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Lice infestation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Localised infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="3714"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Molluscum contagiosum</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="83" subjects_affected="74" subjects_at_risk="1239"/>
                <counts group_id="E2" events="82" subjects_affected="75" subjects_at_risk="1232"/>
                <counts group_id="E3" events="82" subjects_affected="74" subjects_at_risk="1243"/>
                <counts group_id="E4" events="247" subjects_affected="223" subjects_at_risk="3714"/>
                <counts group_id="E5" events="68" subjects_affected="65" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1239"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="3714"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Oral infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Otitis externa</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" events="86" subjects_affected="80" subjects_at_risk="1239"/>
                <counts group_id="E2" events="79" subjects_affected="75" subjects_at_risk="1232"/>
                <counts group_id="E3" events="67" subjects_affected="62" subjects_at_risk="1243"/>
                <counts group_id="E4" events="232" subjects_affected="217" subjects_at_risk="3714"/>
                <counts group_id="E5" events="89" subjects_affected="86" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Otitis media acute</sub_title>
                <counts group_id="E1" events="10" subjects_affected="8" subjects_at_risk="1239"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="1232"/>
                <counts group_id="E3" events="14" subjects_affected="13" subjects_at_risk="1243"/>
                <counts group_id="E4" events="31" subjects_affected="28" subjects_at_risk="3714"/>
                <counts group_id="E5" events="9" subjects_affected="9" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Otitis media chronic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Paronychia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Periorbital cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="20" subjects_affected="20" subjects_at_risk="1239"/>
                <counts group_id="E2" events="30" subjects_affected="30" subjects_at_risk="1232"/>
                <counts group_id="E3" events="14" subjects_affected="14" subjects_at_risk="1243"/>
                <counts group_id="E4" events="64" subjects_affected="64" subjects_at_risk="3714"/>
                <counts group_id="E5" events="24" subjects_affected="23" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Pharyngitis streptococcal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Pharyngotonsillitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="3714"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="1243"/>
                <counts group_id="E4" events="7" subjects_affected="7" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Respiratory syncytial virus bronchiolitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Respiratory syncytial virus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="1239"/>
                <counts group_id="E2" events="12" subjects_affected="11" subjects_at_risk="1232"/>
                <counts group_id="E3" events="11" subjects_affected="9" subjects_at_risk="1243"/>
                <counts group_id="E4" events="31" subjects_affected="28" subjects_at_risk="3714"/>
                <counts group_id="E5" events="9" subjects_affected="7" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection viral</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="3714"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" events="50" subjects_affected="46" subjects_at_risk="1239"/>
                <counts group_id="E2" events="55" subjects_affected="49" subjects_at_risk="1232"/>
                <counts group_id="E3" events="42" subjects_affected="38" subjects_at_risk="1243"/>
                <counts group_id="E4" events="147" subjects_affected="133" subjects_at_risk="3714"/>
                <counts group_id="E5" events="44" subjects_affected="41" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Roseola</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Salmonellosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Scarlet fever</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="1239"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="1232"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="1243"/>
                <counts group_id="E4" events="17" subjects_affected="16" subjects_at_risk="3714"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Skin bacterial infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Skin candida</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Staphylococcal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Streptococcal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1232"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="1243"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="3714"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Subcutaneous abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" events="22" subjects_affected="21" subjects_at_risk="1239"/>
                <counts group_id="E2" events="10" subjects_affected="9" subjects_at_risk="1232"/>
                <counts group_id="E3" events="11" subjects_affected="9" subjects_at_risk="1243"/>
                <counts group_id="E4" events="43" subjects_affected="39" subjects_at_risk="3714"/>
                <counts group_id="E5" events="16" subjects_affected="15" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Tooth abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="117" subjects_affected="106" subjects_at_risk="1239"/>
                <counts group_id="E2" events="132" subjects_affected="124" subjects_at_risk="1232"/>
                <counts group_id="E3" events="132" subjects_affected="122" subjects_at_risk="1243"/>
                <counts group_id="E4" events="381" subjects_affected="352" subjects_at_risk="3714"/>
                <counts group_id="E5" events="129" subjects_affected="122" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="3714"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Viral diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" events="15" subjects_affected="15" subjects_at_risk="1239"/>
                <counts group_id="E2" events="22" subjects_affected="21" subjects_at_risk="1232"/>
                <counts group_id="E3" events="26" subjects_affected="23" subjects_at_risk="1243"/>
                <counts group_id="E4" events="63" subjects_affected="59" subjects_at_risk="3714"/>
                <counts group_id="E5" events="15" subjects_affected="15" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Viral pharyngitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1239"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Viral rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Viral tonsillitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="1239"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="1232"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="1243"/>
                <counts group_id="E4" events="10" subjects_affected="10" subjects_at_risk="3714"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="1289"/>
              </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="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Animal bite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1243"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Arthropod bite</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="1239"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="1232"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="1243"/>
                <counts group_id="E4" events="19" subjects_affected="19" subjects_at_risk="3714"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Arthropod sting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="1243"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Bite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Chemical poisoning</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Clavicle fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Concussion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="3714"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Corneal abrasion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Craniocerebral injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Ear canal injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Ear injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Eye contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Face injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Foreign body in gastrointestinal tract</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1243"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Gingival injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Hand fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Head injury</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="1239"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="1232"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="1243"/>
                <counts group_id="E4" events="17" subjects_affected="17" subjects_at_risk="3714"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Heat stroke</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1243"/>
                <counts group_id="E4" events="7" subjects_affected="7" subjects_at_risk="3714"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="3714"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Lip injury</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Nail avulsion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Radial head dislocation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Scratch</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Skin abrasion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Superficial injury of eye</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Thermal burn</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Tibia fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Tongue injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Upper limb fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Wound</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Cardiac murmur</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Cold agglutinins positive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Otic examination normal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </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="548" subjects_affected="547" subjects_at_risk="1239"/>
                <counts group_id="E2" events="538" subjects_affected="537" subjects_at_risk="1232"/>
                <counts group_id="E3" events="528" subjects_affected="526" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1614" subjects_affected="1610" subjects_at_risk="3714"/>
                <counts group_id="E5" events="550" subjects_affected="549" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Lactose intolerance</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Polydipsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Elbow deformity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Knee deformity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Synovial cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Seborrhoeic keratosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Drooling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Exaggerated startle response</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Febrile convulsion</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="1243"/>
                <counts group_id="E4" events="10" subjects_affected="10" subjects_at_risk="3714"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Gross motor delay</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Lethargy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Nystagmus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Poor quality sleep</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="6" subjects_affected="5" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Post-traumatic headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="534" subjects_affected="534" subjects_at_risk="1239"/>
                <counts group_id="E2" events="535" subjects_affected="535" subjects_at_risk="1232"/>
                <counts group_id="E3" events="533" subjects_affected="533" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1602" subjects_affected="1602" subjects_at_risk="3714"/>
                <counts group_id="E5" events="586" subjects_affected="586" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Speech disorder developmental</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Cephalhaematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Aggression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Depressed mood</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" events="775" subjects_affected="765" subjects_at_risk="1239"/>
                <counts group_id="E2" events="741" subjects_affected="730" subjects_at_risk="1232"/>
                <counts group_id="E3" events="775" subjects_affected="768" subjects_at_risk="1243"/>
                <counts group_id="E4" events="2291" subjects_affected="2263" subjects_at_risk="3714"/>
                <counts group_id="E5" events="838" subjects_affected="822" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Middle insomnia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Restlessness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Sleep disorder</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Sleep terror</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Tearfulness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Terminal insomnia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Polyuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Urinary tract disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Acquired phimosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Balanoposthitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1243"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Bilateral breast buds</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Genital labial adhesions</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Vaginal mucosal blistering</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </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="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1243"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="3714"/>
                <counts group_id="E5" events="5" subjects_affected="4" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Bronchial hyperreactivity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1243"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="3714"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Bronchospasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="1232"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="1243"/>
                <counts group_id="E4" events="7" subjects_affected="7" subjects_at_risk="3714"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Catarrh</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="3714"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="36" subjects_affected="33" subjects_at_risk="1239"/>
                <counts group_id="E2" events="42" subjects_affected="42" subjects_at_risk="1232"/>
                <counts group_id="E3" events="38" subjects_affected="38" subjects_at_risk="1243"/>
                <counts group_id="E4" events="116" subjects_affected="113" subjects_at_risk="3714"/>
                <counts group_id="E5" events="38" subjects_affected="36" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1243"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="3714"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1239"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="7" subjects_affected="7" subjects_at_risk="3714"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="1239"/>
                <counts group_id="E2" events="12" subjects_affected="11" subjects_at_risk="1232"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="1243"/>
                <counts group_id="E4" events="27" subjects_affected="26" subjects_at_risk="3714"/>
                <counts group_id="E5" events="11" subjects_affected="11" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Nasal discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Rales</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Respiratory disorder</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="1243"/>
                <counts group_id="E4" events="6" subjects_affected="6" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Respiratory distress</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Respiratory tract congestion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="1239"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1232"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="1243"/>
                <counts group_id="E4" events="8" subjects_affected="8" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" events="23" subjects_affected="22" subjects_at_risk="1239"/>
                <counts group_id="E2" events="26" subjects_affected="23" subjects_at_risk="1232"/>
                <counts group_id="E3" events="21" subjects_affected="20" subjects_at_risk="1243"/>
                <counts group_id="E4" events="70" subjects_affected="65" subjects_at_risk="3714"/>
                <counts group_id="E5" events="22" subjects_affected="21" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Sinus congestion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Sneezing</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Tonsillar hypertrophy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract congestion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="1239"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="1232"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="1243"/>
                <counts group_id="E4" events="15" subjects_affected="14" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Blister</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="3714"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Dermatitis allergic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Dermatitis atopic</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1239"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="1232"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="1243"/>
                <counts group_id="E4" events="9" subjects_affected="9" subjects_at_risk="3714"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1232"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1243"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Dermatitis diaper</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="1239"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="1232"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="1243"/>
                <counts group_id="E4" events="12" subjects_affected="10" subjects_at_risk="3714"/>
                <counts group_id="E5" events="5" subjects_affected="5" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Drug eruption</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="1232"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1243"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="3714"/>
                <counts group_id="E5" events="5" subjects_affected="5" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Eczema nummular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Hyperkeratosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Ingrowing nail</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Keratosis pilaris</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Macule</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Miliaria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Papule</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Prurigo</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="352" subjects_affected="352" subjects_at_risk="1239"/>
                <counts group_id="E2" events="331" subjects_affected="331" subjects_at_risk="1232"/>
                <counts group_id="E3" events="360" subjects_affected="360" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1043" subjects_affected="1043" subjects_at_risk="3714"/>
                <counts group_id="E5" events="378" subjects_affected="378" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Seborrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Skin irritation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="3714"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Skin mass</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Skin warm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Solar dermatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Swelling face</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="6" subjects_affected="4" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Social circumstances</title>
            <event_list>
              <event>
                <sub_title>Diet noncompliance</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="1289"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1232"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </event>
              <event>
                <sub_title>Pallor</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1239"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1232"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1243"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="3714"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="1289"/>
              </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/NCT01702428
org study id: 115648
secondary id: 2011-004891-12
nct id: NCT01702428
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate consistency in terms of the immune response to three
      different lots of GSK Biologicals' trivalent MMR vaccine manufactured to target potencies,
      and compare its immunogenicity to Merck & Co., Inc.'s MMR vaccine, which is approved for use
      in the United States (US).
This study will evaluate the consistency of the immune response to three different lots of
      GSK Biologicals' trivalent investigational MMR vaccine (referred to as INV_MMR vaccine,
      throughout this document) and compare its immunogenicity 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 INV_MMR vaccine will be given as
      one of three consistency lots manufactured to target potencies designated as INV_MMR_L1,
      INV_MMR_L2 and INV_MMR_L3. The COM_MMR vaccine will be given as one of two lots designated
      COM_MMR_L1 and COM_MMR_L2 and will be analysed as pooled lots within the study. The MMR
      vaccine will be co-administered with Varivax (VV), Havrix (HAV) and (in the US sub-cohort
      only) Prevnar 13 (PCV-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
time frame: At Day 42
description: Seroresponse was defined as post-vaccination anti-measles virus antibody concentration ≥200 milli International Unit/Milliliter (mIU/mL) among subjects who were seronegative (antibody concentration <150 mIU/mL) before vaccination. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.
measure: Anti-measles Virus Antibody Concentrations
time frame: At Day 42
description: Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.
measure: Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value
time frame: At Day 42
description: Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥10 ELISA Unit/Milliliter (EU/mL) among subjects who were seronegative (antibody concentrations <5 EU/mL) before vaccination. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.
measure: Anti-mumps Virus Antibody Concentration
time frame: At Day 42
description: Antibody concentrations were expressed as GMCs in EU/mL. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.
measure: Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value
time frame: At Day 42
description: Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥10 International Unit/Milliliter (IU/mL) among subjects who were seronegative (antibody concentrations <4 IU/mL) before vaccination. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.
measure: Anti-rubella Virus Antibody Concentration
time frame: At Day 42
description: Antibody concentrations were expressed as GMCs in IU/mL. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.
measure: Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups
time frame: At Day 42
description: Seroresponse was defined as post-vaccination anti-measles virus antibody concentration ≥200 mIU/mL among subjects who were seronegative (antibody concentration <150 mIU/mL) before vaccination. Criteria to demonstrate an acceptable immune response for INV_MMR in terms of seroresponse rates to measles virus at Day 42: The LL of 2-sided 95% CI for the seroresponse rate for the pooled INV_MMR lots is ≥90% for antibodies to measles virus.
measure: Anti-measles Virus Antibody Concentrations in Pooled MMR Groups
time frame: At Day 42
description: Antibody concentrations were expressed as GMCs in mIU/mL.
measure: Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups
time frame: At Day 42
description: Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥10 EU/mL among subjects who were seronegative (antibody concentrations <5 EU/mL) before vaccination.
measure: Anti-mumps Virus Antibody Concentration in Pooled MMR Groups
time frame: At Day 42
description: Antibody concentrations were expressed as GMCs in EU/mL.
measure: Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups
time frame: At Day 42
description: Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥10 IU/mL among subjects who were seronegative (antibody concentrations <4 IU/mL) before vaccination. Criteria to demonstrate an acceptable immune response for INV_MMR in terms of seroresponse rates to rubella virus at Day 42: The LL of 2-sided 95% CI for the seroresponse rate for the pooled INV_MMR lots is ≥90% for antibodies to rubella virus.
measure: Anti-rubella Virus Antibody Concentration in Pooled MMR Groups
time frame: At Day 42
description: Antibody concentrations were expressed as GMCs in IU/mL.
measure: Percentage of Subjects With an Anti-Varicella Zoster Virus (VZV) Antibody Concentration Equal to or Above the Cut-off Value in US Sub-cohort of Pooled MMR Groups
time frame: At Day 42
description: Seroresponse was defined as post-vaccination anti-VZV antibody concentration ≥75 mIU/mL among subjects who were seronegative (antibody concentration <25 mIU/mL) before vaccination.
measure: Anti-VZV Virus Antibody Concentration in US Sub-cohort of Pooled MMR Groups
time frame: At Day 42
description: Antibody concentrations were expressed as GMCs in mIU/mL.
measure: Percentage of Subjects With an Anti-HAV Antibody Concentration Equal to or Above the Cut-off Value in US Sub-cohort of Pooled MMR Groups
time frame: At Day 42
description: Percentage of subjects with an Anti-HAV antibody concentration equal to or above 15 mIU/mL were reported.
measure: Anti-HAV Antibody Concentrations in US Sub-cohort of Pooled MMR Groups
time frame: At Day 42
description: Antibody concentrations were expressed as GMCs in mIU/mL.
measure: Anti-S.Pneumoniae Antibody Concentration in US Sub-cohort of Pooled MMR Groups
time frame: At Day 42
description: Antibody concentrations were expressed as GMCs in microgram/Milliliter (µg/mL).
measure: Number of Subjects With Any Solicited Local Adverse Events (AEs)
time frame: During the 4-days (Days 0-3) post-vaccination period
description: Assessed solicited local AEs were pain, redness and swelling. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.
measure: Number of Subjects With Any Solicited General AEs
time frame: During the 15-days (Days 0-14) post-vaccination period
description: Assessed solicited general AEs were drowsiness, irritability and loss of appetite. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.
measure: Number of Subjects Reporting Any Fever
time frame: During the 43-days (Days 0-42) post-vaccination period
description: Any fever = Fever ≥ 38°C.
measure: Number of Subjects Reporting Any Rash
time frame: During the 43-days (Days 0-42) post-vaccination period
description: Assessed were any localized or generalized rash, rash with fever, varicella-like rash, measles/rubella-like rash. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.
measure: Number of Subjects Reporting Any MMR Specific Solicited AEs
time frame: During the 43-days (Days 0-42) post-vaccination period
description: Assessed MMR specific solicited AEs were any suspected signs of meningism including febrile convulsions and parotid/salivary gland swelling. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.
measure: Number of Subjects Reporting Any Unsolicited AEs
time frame: During the 43-days (Days 0-42) post-vaccination period
description: Unsolicited adverse event (AE) was defined as any adverse event reported in addition to those solicited during the clinical study and also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.
measure: Number of Subjects Reporting AEs of Specific Interest
time frame: From Day 0 through the end of study (Day 180)
description: AEs of specific interest included new onset chronic disease (NOCD) (e.g., autoimmune disorders, asthma, type I diabetes, vasculitis, celiac disease, conditions associated with sub-acute or chronic thrombocytopenia and allergies) and AEs prompting emergency room (ER) visits.
measure: Number of Subjects Reporting Any Serious Adverse Events (SAEs)
time frame: From Day 0 through the end of study (Day 180)
description: SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity. Any SAE = Occurrence of SAE regardless of intensity grade or relation to vaccination.
arm group label: INV_MMR_L1 Group
arm group type: Experimental
description: Subjects receive 1 dose of GSK's candidate combined measles, mumps and rubella (MMR) investigational vaccine (INV_MMR) Lot 1 (L1) co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects are also given PCV-13 vaccine. The MMR vaccine is administered subcutaneously in the triceps region of the left arm while the VV vaccine is administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines are administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
arm group label: INV_MMR_L2 Group
arm group type: Experimental
description: Subjects receive 1 dose of GSK's candidate combined measles, mumps and rubella (MMR) investigational vaccine (INV_MMR) Lot 2 (L2) co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects are also given PCV-13 vaccine. The MMR vaccine is administered subcutaneously in the triceps region of the left arm while the VV vaccine is administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines are administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
arm group label: INV_MMR_L3 Group
arm group type: Experimental
description: Subjects receive 1 dose of GSK's candidate combined measles, mumps and rubella (MMR) investigational vaccine (INV_MMR) Lot 3 (L3) co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects are also given PCV-13 vaccine. The MMR vaccine is administered subcutaneously in the triceps region of the left arm while the VV vaccine is administered subcutaneously in the triceps region of the right arm. 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 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects are also given PCV-13 vaccine. The MMR vaccine is administered subcutaneously in the triceps region of the left arm while the VV vaccine is administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines are administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis is conducted for this group.
intervention type: Biological
intervention name: Priorix
description: Subjects receive 1 dose of MMR vaccine which is administered subcutaneously in the triceps region of the left arm.
arm group label: INV_MMR_L1 Group
arm group label: INV_MMR_L2 Group
arm group label: INV_MMR_L3 Group
other name: GSK Biologicals' live attenuated measles
other name: mumps and rubella vaccine (GSK209762)
intervention type: Biological
intervention name: M-M-R II
description: Subjects receive 1 dose of MMR vaccine which is administered subcutaneously in the triceps region of the left arm.
arm group label: COM_MMR Group
intervention type: Biological
intervention name: Varivax
description: Subjects receive 1 dose of VV vaccine which is administered subcutaneously in the triceps region of the right arm.
arm group label: COM_MMR Group
arm group label: INV_MMR_L1 Group
arm group label: INV_MMR_L2 Group
arm group label: INV_MMR_L3 Group
intervention type: Biological
intervention name: Havrix
description: Subjects receive 1 dose of HAV vaccine which is administered intramuscularly in the anterolateral region of the right thigh.
arm group label: COM_MMR Group
arm group label: INV_MMR_L1 Group
arm group label: INV_MMR_L2 Group
arm group label: INV_MMR_L3 Group
intervention type: Biological
intervention name: Prevnar 13
description: US subjects receive 1 dose of PCV-13 vaccine which is administered intramuscularly in the anterolateral region of the left thigh.
arm group label: COM_MMR Group
arm group label: INV_MMR_L1 Group
arm group label: INV_MMR_L2 Group
arm group label: INV_MMR_L3 Group
criteria: 
gender: All
minimum age: 12 Months
maximum age: 15 Months
healthy volunteers: Accepts Healthy Volunteers
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
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country: Estonia
country: Finland
country: Mexico
country: Puerto Rico
country: Spain
country: United States
citation: Klein NP, Abu-Elyazeed R, Povey M, Macias Parra M, Diez-Domingo J, Ahonen A, Korhonen T, Tinoco JC, Weiner L, Marshall GS, Silas PE, Sarpong KO, Ramsey KP, Fling JA, Speicher D, Campos M, Munjal I, Peltier C, Vesikari T, Baccarini C, Caplanusi A, Gillard P, Carryn S, Henry O. Immunogenicity and Safety of a Measles-Mumps-Rubella Vaccine Administered as a First Dose to Children Aged 12 to 15 Months: A Phase III, Randomized, Noninferiority, Lot-to-Lot Consistency Study. J Pediatric Infect Dis Soc. 2020 Apr 30;9(2):194-201. doi: 10.1093/jpids/piz010.
PMID: 30849175
responsible party type: Sponsor
mesh term: Measles
mesh term: Rubella
mesh term: Heptavalent Pneumococcal Conjugate Vaccine
sharing ipd: Yes
ipd description: IPD is available via the Clinical Study Data Request site (click on the link provided below)
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
ipd access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
ipd url: https://clinicalstudydatarequest.com/Posting.aspx?ID=19887
participant flow: 
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