<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02979639</url>
  </required_header>
  <id_info>
    <org_study_id>204928</org_study_id>
    <nct_id>NCT02979639</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Impact of Reactogenicity on Quality of Life (QoL), After Administration of GlaxoSmithKline (GSK) Biologicals' Candidate Herpes Zoster Subunit (HZ/su) Vaccine (GSK1437173A) in Adults ≥ 50 Years of Age</brief_title>
  <official_title>Study to Evaluate the Impact of Reactogenicity on Quality of Life (QoL), After Administration of GSK Biologicals' Candidate Herpes Zoster Subunit (HZ/su) Vaccine (GSK1437173A) in Adults ≥ 50 Years 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 the impact of reactogenicity of GSK Biologicals'&#xD;
      HZ/su vaccine on Quality of Life (QoL) in adults ≥ 50 years of age&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will evaluate the impact of HZ/su vaccination on the QoL, 400 adults ≥ 50 years of&#xD;
      age (YOA). Subjects will be asked to respond to a series of SF-36 and EQ-5D questionnaires&#xD;
      before and after vaccination following a 2 month schedule. To estimate the impact of&#xD;
      reactogenicity on an individual's physical functioning (PF) and QoL, the study will compare&#xD;
      subject questionnaire responses made during two periods, i.e., pre-vaccination and&#xD;
      post-vaccination. The difference will be considered to be the effect of vaccination and&#xD;
      reactogenicity on the PF and QoL. To characterize the study population and determine if&#xD;
      frailty may influence reactogenicity and consequently the impact on QoL scores, the subjects'&#xD;
      frailty status will be assessed at the first inclusion visit. In addition to the SF-36 and&#xD;
      EQ-5D questionnaires, a more complete characterization of the reactogenicity of the vaccine&#xD;
      will be made by including a detailed collection of the use of healthcare resources and the&#xD;
      occurrence of symptoms through diary card data collection. Impact on days of work loss, both&#xD;
      for the subject or for a caregiver, as applicable, will also be assessed.&#xD;
&#xD;
      Note that as a result of internal change in data standards terminology, the study data&#xD;
      collected was converted to cDISC and the statistical analysis plan was amended accordingly.&#xD;
      &quot;Day 0&quot; in the study design was replaced by &quot;Day 1&quot;; consequently, &quot;Day n&quot; was replaced by&#xD;
      &quot;Day n+1&quot;. Thus, the timeframes (Day 0, Day n) of Outcome Measures described in this study&#xD;
      record are different to that denoted in the full protocol document posted.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 16, 2017</start_date>
  <completion_date type="Actual">May 24, 2018</completion_date>
  <primary_completion_date type="Actual">April 12, 2017</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the Short Form 36-item-health Survey (SF36) Physical Functioning (PF) From Baseline Score to Mean Score After First Dose</measure>
    <time_frame>From Baseline at Day -7 to Day 8 after first dose</time_frame>
    <description>Descriptive analysis of the mean and standard deviation (SD) of the change from baseline of the SF-36 physical functioning (PF) score pre- and post dose 1 overall. Changes in the score were measured as Baseline versus mean score over the period Day 2 to Day 8 after first vaccination. Baseline for dose 1 is defined as the mean of the assessments at Day -7 and Day 1. The post-vaccination completion of SF-36 questionnaires brought home by the subjects were Days 2 to 7, with Day 8 to be filled in at the site. The SF-36 scale scores are constructed following the summated ratings of the questions and standardized SF-36 scoring algorithm. Scores range from 0 to 100, with a higher score representing a higher level of functioning.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Mean SF-36 PF Scale Scores From Baseline Score to Mean Score After Second Dose</measure>
    <time_frame>From Day -7 to first dose until Day 8 after second dose (equivalent to study Days -7 to 68)</time_frame>
    <description>Descriptive analysis of the mean and standard deviation of the change from baseline of the SF-36 PF scale score pre and post dose 2 overall. Changes in the score were measured as Baseline versus mean score over the period Day 2 to Day 8 after second vaccination. For dose 2 baseline is defined as the mean of the three assessments at Day -7, Day 1 and Day 61 (Day 1 for dose 2). The post-vaccination completion of SF-36 questionnaires brought home by the subjects were on Day 2 to Day 7, with Day 8 to be filled in at the site. The SF-36 scale scores are constructed following the summated ratings of the questions and standardized SF-36 scoring algorithm. Scores range from 0 to 100, with a higher score representing a higher level of functioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Mean SF-36 PF Single Item Scores After First Dose</measure>
    <time_frame>From Baseline at Day -7 to Day 8 after first dose</time_frame>
    <description>Descriptive analysis of the change in mean SF-36 PF single item score from baseline. Changes in the score were measured as Baseline versus mean score over the period Day 2 to Day 8 after the first vaccination. Baseline for dose 1 is defined as the mean of the assessments at Day -7 and Day 1. The post-vaccination completion of SF-36 questionnaires brought home by the subjects were Days 2 to 7, with Day 8 to be filled in at the site. The SF-36 scale scores are constructed following the summated ratings of the questions and standardized SF-36 scoring algorithm. Scores range from 0 to 100, with a higher score representing a higher level of functioning. Among items are vigorous activities (running, lifting heavy objects, participating in strenuous sports), moderate activities (moving a table, pushing a vaccum cleaner, bowling, or playing golf) and others, described in the categories below.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Mean SF-36 PF Single Item Scores After Second Dose</measure>
    <time_frame>From Day -7 to first dose until Day 8 after second dose (equivalent to study Days -7 to 68)</time_frame>
    <description>Descriptive analysis of the change in mean SF-36 PF single item score from baseline. Baseline versus mean score over the period Day 2 to Day 8 after each vaccination. For dose 2 baseline is defined as the mean of the three assessments at Day -7, Day 1 and Day 61 (equivalent to Day 1 for dose 2) The post-vaccination completion of SF-36 questionnaires brought home by the subjects were on Day 2 to Day 7, with Day 8 to be filled in at the site. The SF-36 scale scores are constructed following the summated ratings of the questions and standardized SF-36 scoring algorithm. Scores range from 0 to 100, with a higher score representing a higher level of functioning. Among items are vigorous activities (running, lifting heavy objects, participating in strenuous sports), moderate activities (moving a table, pushing a vaccum cleaner, bowling, or playing golf) and others, described in the categories below.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in SF-36 Role Physical Scores After First Dose</measure>
    <time_frame>From Baseline at Day -7 to Day 8 after first dose</time_frame>
    <description>Descriptive analysis. SF-36 Role physical scores change was measured from baseline score. Baseline versus mean score on Day 8 after first vaccination. Baseline for dose 1 is defined as the mean of the assessments at Day -7 and Day 1. The post-vaccination completion of SF-36 questionnaires brought home by the subjects were on Day 2 to Day 7, with Day 8 to be filled in at the site. The SF-36 scale scores are constructed following the summated ratings of the questions and standardized SF-36 scoring algorithm. Scores range from 0 to 100, with a higher score representing a higher level of functioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in SF-36 Role Physical Scores After Second Dose</measure>
    <time_frame>From Day -7 to first dose until Day 8 after second dose (equivalent to study Days -7 to 68)</time_frame>
    <description>Descriptive analysis. SF-36 Role Physical scores change was measured from baseline score. Changes in the score were measured as Baseline versus Day 8 score after the second vaccination. For dose 2 baseline is defined as the mean of the three assessments at Day -7, Day 1 and Day 61 (equivalent to Day 1 for dose 2) The post-vaccination completion of SF-36 questionnaires brought home by the subjects were on Day 2 to Day 7, with Day 8 to be filled in at the site. The SF-36 scale scores are constructed following the summated ratings of the questions and standardized SF-36 scoring algorithm. Scores range from 0 to 100, with a higher score representing a higher level of functioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality-adjusted Life Year (QALY) After First Dose</measure>
    <time_frame>From Baseline at Day -7 to Day 8 after first dose</time_frame>
    <description>Descriptive analysis. QALY estimation is done from baseline score, based on EQ-5D questionnaires. Baseline versus combined score over the period Day 2 to Day 8 after each vaccination. Baseline for dose 1 is defined as the mean of the assessments at Day -7 and Day 1. The post-vaccination completion of EQ-5D questionnaires brought home by the subjects were on Day 2 to Day 7, with Day 8 to be filled in at the site. The EQ-5D is a generic measure of health status that provides a simple description profile based on 5 items: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, which are used to generate the EQ-5D index utility score. The EQ-5D index utility score ranges from 0 (worst health state) to 1 (perfect health state); 1 reflects the best outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in QALY After Second Dose</measure>
    <time_frame>From Day -7 to first dose until Day 8 after second dose (equivalent to study Days -7 to 68)</time_frame>
    <description>Descriptive analysis. QALY estimation is done from baseline score, based on EQ-5D questionnaires. Baseline versus combined score over the period Day 2 to Day 8 after each vaccination. For dose 2 baseline is defined as the mean of the three assessments at Day -7, Day 1 and Day 61 (equivalent to Day 1 for dose 2) The post-vaccination completion of SF-36 and EQ-5D questionnaires brought home by the subjects were on Day 2 to Day 7, with Day 8 to be filled in at the site. The EQ-5D is a generic measure of health status that provides a simple description profile based on 5 items: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 items are combined to generate health profiles (e.g. 1-no problem/no symptom) and profiles are subsequently converted to a continuous single index utility score (higher scores represent a better quality of life).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Reactogenicity-triggered Medically Attended Visits After First Dose</measure>
    <time_frame>From Day 1 to Day 7 after first dose</time_frame>
    <description>Medical attention and health resource utilization triggered by frequency of reactogenicity events. Healthcare resources included staff involved in the following activities: telephone calls, visit to general practitioner, visit to specialist, visit to emergency room and hospitalizations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Reactogenicity-triggered Medically Attended Visits After Second Dose</measure>
    <time_frame>From Day 1 to Day 7 after second dose</time_frame>
    <description>Medical attention and health resource utilization triggered by frequency of reactogenicity events. Healthcare resources included staff involved in the following activities: telephone calls, visit to general practitioner, visit to specialist, visit to emergency room and hospitalizations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days of Work Loss for Subjects After First Dose</measure>
    <time_frame>From Day 1 to Day 7 after first dose</time_frame>
    <description>Descriptive analysis. Estimation of work loss due to any reaction related to the study vaccine for subjects, expressed in days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days of Work Loss for Subjects After Second Dose</measure>
    <time_frame>From Day 1 to Day 7 after second dose</time_frame>
    <description>Descriptive analysis. Estimation of work loss due to any reaction related to the study vaccine for subjects, expressed in days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days of Work Loss for Non-dedicated Caregivers After First Dose</measure>
    <time_frame>From Day 1 to Day 7 after first dose</time_frame>
    <description>Descriptive analysis. Estimation of work loss of non-dedicated caregivers expressed in days.Data was not reported for this outcome measure as there was no work loss among the non-dedicated caregivers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days of Work Loss for Non-dedicated Caregivers After Second Dose</measure>
    <time_frame>From Day 1 to Day 7 after second dose</time_frame>
    <description>Descriptive analysis. Estimation of work loss due to any reaction related to the study vaccine for non-dedicated caregivers, expressed in days. Data was not reported for this outcome measure as there was no work loss among the non-dedicated caregivers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days of Extra Work for Dedicated Caregivers After First Dose</measure>
    <time_frame>From Day 1 to Day 7 after first dose</time_frame>
    <description>Descriptive analysis. Estimation of extra work for dedicated caregivers. Data was not reported for this outcome measure as there was no extra work for the dedicated caregivers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days of Extra Work for Dedicated Caregivers After Second Dose</measure>
    <time_frame>From Day 1 to Day 7 after second dose</time_frame>
    <description>Descriptive analysis. Estimation of extra work for dedicated caregivers, expressed in days. Data was not reported for this outcome measure as there was no extra work for the dedicated caregivers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Any and Grade 3 Solicited Local Symptoms After First Dose</measure>
    <time_frame>During a 7-day follow-up period (Day 1 to Day 7) after first dose.</time_frame>
    <description>Assessed solicited local symptoms were pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 erythema/swelling =erythema/swelling spreading beyond 100 millimeters (mm) of injection site.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Second Dose</measure>
    <time_frame>During a 7-day follow-up period (Day 1 to Day 7) after second dose.</time_frame>
    <description>Assessed solicited local symptoms were pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 erythema/swelling=erythema/swelling spreading beyond 100 millimeters (mm) of injection site.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Days With Solicited Local Symptoms After First Dose</measure>
    <time_frame>During a 7-day follow-up period (Day 1 to Day 7) after first dose.</time_frame>
    <description>Assessed solicited local symptoms were pain, erythema and swelling.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Days With Solicited Local Symptoms After Second Dose</measure>
    <time_frame>During a 7-day follow-up period (Day 1 to Day 7) after second dose.</time_frame>
    <description>Assessed solicited local symptoms were pain, erythema and swelling.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After First Dose</measure>
    <time_frame>During a 7-day follow-up period (Day 1 to Day 7) after first dose.</time_frame>
    <description>Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and temperature [defined as oral, axillary or tympanic temperature equal to or above (≥)37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal everyday activities. Grade 3 temperature=temperature≥39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Second Dose</measure>
    <time_frame>During a 7-day follow-up period (Day 1 to Day 7) after second dose.</time_frame>
    <description>Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and temperature [defined as oral, axillary, tympanic temperature ≥ 37.5 °C]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature≥39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Days With Solicited General Symptoms After First Dose</measure>
    <time_frame>During a 7-day follow-up period (Day 1 to Day 7) after first dose.</time_frame>
    <description>Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and temperature [defined as oral, axillary or tympanic temperature equal to or above (≥)37.5 degrees Celsius (°C)].</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Days With Solicited General Symptoms After Second Dose</measure>
    <time_frame>During a 7-day follow-up period (Day 1 to Day 7) after second dose.</time_frame>
    <description>Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and temperature [defined as oral, axillary or tympanic temperature equal to or above (≥)37.5 degrees Celsius (°C)].</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)</measure>
    <time_frame>During a 30-day follow-up period (Day 1 to Day 30) after any vaccination (across doses).</time_frame>
    <description>An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.&#xD;
Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Any and Related Serious Adverse Events (SAEs) During the Entire Study Period</measure>
    <time_frame>From Day 1 to study end at Month 14</time_frame>
    <description>SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs)</measure>
    <time_frame>From Day 1 to study end at Month 14</time_frame>
    <description>pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">404</enrollment>
  <condition>Herpes Zoster</condition>
  <arm_group>
    <arm_group_label>GSK1437173A Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects ≥ 50 years of age who will receive two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>GSK Biologicals Herpes Zoster subunit (HZ/su) vaccine (GSK 1437173A)</intervention_name>
    <description>2 doses administered by intramuscular (IM) injection into the deltoid muscle of the non-dominant arm on a 2 month schedule.</description>
    <arm_group_label>GSK1437173A Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects who, in the opinion of the investigator, can and will comply with the&#xD;
             requirements of the protocol (e.g., completion of the questionnaires and diary cards).&#xD;
&#xD;
          -  Written informed consent obtained from the subject prior to performance of any study&#xD;
             specific procedure.&#xD;
&#xD;
          -  A male or female aged ≥ 50 YOA at the time of consent.&#xD;
&#xD;
          -  Female subjects of non-childbearing potential may be enrolled in the study.&#xD;
&#xD;
               -  For this study population, non-childbearing potential is defined as current tubal&#xD;
                  ligation, hysterectomy, ovariectomy or post-menopause.&#xD;
&#xD;
          -  Female subjects of childbearing potential may be enrolled in the study, if the&#xD;
             subject:&#xD;
&#xD;
               -  has practiced adequate contraception for 30 days prior to vaccination, and&#xD;
&#xD;
               -  has a negative pregnancy test on the day of vaccination, and&#xD;
&#xD;
               -  has agreed to continue adequate contraception during the entire treatment period&#xD;
                  and for 2 months after completion of the vaccination series.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any condition which, in the judgment of the investigator, would make intramuscular&#xD;
             (IM) injection unsafe.&#xD;
&#xD;
          -  Use or planned use of any investigational or non-registered product (drug or vaccine)&#xD;
             other than the study vaccine or current participation or planned concurrent&#xD;
             participation in another clinical study, in which the subject has been or will be&#xD;
             exposed to an investigational or a non-investigational product (pharmaceutical product&#xD;
             or device) during the period starting 30 days before the first dose of study vaccine&#xD;
             and the study end.&#xD;
&#xD;
          -  Use or anticipated use of immunosuppressants or other immune-modifying drugs during&#xD;
             the period starting 180 days prior to study start and during the whole study period.&#xD;
             This includes chronic administration of corticosteroids (&gt; 14 consecutive days of&#xD;
             prednisone at a dose of ≥ 20 mg/day [or equivalent]), long-acting immune-modifying&#xD;
             agents (e.g., infliximab) or immunosuppressive/cytotoxic therapy (e.g., medications&#xD;
             used during cancer chemotherapy, organ transplantation or to treat autoimmune&#xD;
             disorders). Inhaled, topical and intra-articular corticosteroids are allowed.&#xD;
&#xD;
          -  Any confirmed or suspected immunosuppressive or immunodeficient condition resulting&#xD;
             from disease (e.g., malignancy, human immunodeficiency virus [HIV] infection) or&#xD;
             immunosuppressive/cytotoxic therapy (e.g., medications used during cancer&#xD;
             chemotherapy, organ transplantation or to treat autoimmune disorders).&#xD;
&#xD;
          -  Administration of immunoglobulins and/or any blood products in the period starting 90&#xD;
             days preceding the first dose of study vaccine or planned administration during the&#xD;
             study period.&#xD;
&#xD;
          -  Administration or planned administration of a live vaccine in the period starting 30&#xD;
             days before the first dose of study vaccine and ending 30 days after the last dose of&#xD;
             study vaccine, or, administration or planned administration of a non-replicating&#xD;
             vaccine in the period starting 15 days prior to and ending 14 days after either dose&#xD;
             of study vaccine.&#xD;
&#xD;
          -  Previous or planned administration of a vaccine against HZ (including an&#xD;
             investigational or non-registered vaccine) other than the study vaccine, during the&#xD;
             entire study period.&#xD;
&#xD;
          -  History of HZ.&#xD;
&#xD;
          -  History of any reaction or hypersensitivity likely to be exacerbated by any component&#xD;
             of the vaccine.&#xD;
&#xD;
          -  Female planning to become pregnant or planning to discontinue contraceptive&#xD;
             precautions.&#xD;
&#xD;
          -  Pregnant or lactating female.&#xD;
&#xD;
          -  Significant underlying illness requiring medications that might confound the&#xD;
             evaluation of general/ local AEs, or in the opinion of the investigator, would be&#xD;
             expected to prevent completion of the study.&#xD;
&#xD;
          -  Any other condition that, in the opinion of the investigator, might interfere with the&#xD;
             evaluations required by the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</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>Oakland</city>
        <state>California</state>
        <zip>94612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80906</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>Meridian</city>
        <state>Idaho</state>
        <zip>83646</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>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Corvallis</city>
        <state>Oregon</state>
        <zip>97330</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Uniontown</city>
        <state>Pennsylvania</state>
        <zip>15401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Spartanburg</city>
        <state>South Carolina</state>
        <zip>29303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <results_first_submitted>April 11, 2018</results_first_submitted>
  <results_first_submitted_qc>September 19, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">October 16, 2018</results_first_posted>
  <last_update_submitted>September 18, 2019</last_update_submitted>
  <last_update_submitted_qc>September 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Herpes Zoster</keyword>
  <keyword>Reactogenicity</keyword>
  <keyword>Quality of life</keyword>
  <keyword>Shingles</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Herpes Simplex</mesh_term>
    <mesh_term>Herpes Zoster</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 30, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT02979639/SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 16, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT02979639/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>A total of 404 subjects were enrolled in the study. However,1 subject was considered not eligible per the exclusion criteria (had previously received a Zoster vaccine) &amp; 2 subjects were not vaccinated due to voluntary consent withdrawal.Hence,401 subjects were considered to have started the study &amp; administered the first study vaccine (Exposed Set)</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>GSK1437173A Group</title>
          <description>Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="401"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="387"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal based on medical judgement</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>GSK1437173A Group</title>
          <description>Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="401"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64.6" spread="8.8"/>
                  </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="235"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="166"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>African Heritage/African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>American Indian or Alaskan Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian - East Asian Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian - South East Asian Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White - Arabic / North African Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White - Caucasian / European Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="332"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in the Short Form 36-item-health Survey (SF36) Physical Functioning (PF) From Baseline Score to Mean Score After First Dose</title>
        <description>Descriptive analysis of the mean and standard deviation (SD) of the change from baseline of the SF-36 physical functioning (PF) score pre- and post dose 1 overall. Changes in the score were measured as Baseline versus mean score over the period Day 2 to Day 8 after first vaccination. Baseline for dose 1 is defined as the mean of the assessments at Day -7 and Day 1. The post-vaccination completion of SF-36 questionnaires brought home by the subjects were Days 2 to 7, with Day 8 to be filled in at the site. The SF-36 scale scores are constructed following the summated ratings of the questions and standardized SF-36 scoring algorithm. Scores range from 0 to 100, with a higher score representing a higher level of functioning.</description>
        <time_frame>From Baseline at Day -7 to Day 8 after first dose</time_frame>
        <population>The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1437173A Group</title>
            <description>Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in the Short Form 36-item-health Survey (SF36) Physical Functioning (PF) From Baseline Score to Mean Score After First Dose</title>
          <description>Descriptive analysis of the mean and standard deviation (SD) of the change from baseline of the SF-36 physical functioning (PF) score pre- and post dose 1 overall. Changes in the score were measured as Baseline versus mean score over the period Day 2 to Day 8 after first vaccination. Baseline for dose 1 is defined as the mean of the assessments at Day -7 and Day 1. The post-vaccination completion of SF-36 questionnaires brought home by the subjects were Days 2 to 7, with Day 8 to be filled in at the site. The SF-36 scale scores are constructed following the summated ratings of the questions and standardized SF-36 scoring algorithm. Scores range from 0 to 100, with a higher score representing a higher level of functioning.</description>
          <population>The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.</population>
          <units>Score units</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="400"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" spread="10.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Mean SF-36 PF Scale Scores From Baseline Score to Mean Score After Second Dose</title>
        <description>Descriptive analysis of the mean and standard deviation of the change from baseline of the SF-36 PF scale score pre and post dose 2 overall. Changes in the score were measured as Baseline versus mean score over the period Day 2 to Day 8 after second vaccination. For dose 2 baseline is defined as the mean of the three assessments at Day -7, Day 1 and Day 61 (Day 1 for dose 2). The post-vaccination completion of SF-36 questionnaires brought home by the subjects were on Day 2 to Day 7, with Day 8 to be filled in at the site. The SF-36 scale scores are constructed following the summated ratings of the questions and standardized SF-36 scoring algorithm. Scores range from 0 to 100, with a higher score representing a higher level of functioning.</description>
        <time_frame>From Day -7 to first dose until Day 8 after second dose (equivalent to study Days -7 to 68)</time_frame>
        <population>The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1437173A Group</title>
            <description>Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Mean SF-36 PF Scale Scores From Baseline Score to Mean Score After Second Dose</title>
          <description>Descriptive analysis of the mean and standard deviation of the change from baseline of the SF-36 PF scale score pre and post dose 2 overall. Changes in the score were measured as Baseline versus mean score over the period Day 2 to Day 8 after second vaccination. For dose 2 baseline is defined as the mean of the three assessments at Day -7, Day 1 and Day 61 (Day 1 for dose 2). The post-vaccination completion of SF-36 questionnaires brought home by the subjects were on Day 2 to Day 7, with Day 8 to be filled in at the site. The SF-36 scale scores are constructed following the summated ratings of the questions and standardized SF-36 scoring algorithm. Scores range from 0 to 100, with a higher score representing a higher level of functioning.</description>
          <population>The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.</population>
          <units>Score units</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="389"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" spread="10.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Mean SF-36 PF Single Item Scores After First Dose</title>
        <description>Descriptive analysis of the change in mean SF-36 PF single item score from baseline. Changes in the score were measured as Baseline versus mean score over the period Day 2 to Day 8 after the first vaccination. Baseline for dose 1 is defined as the mean of the assessments at Day -7 and Day 1. The post-vaccination completion of SF-36 questionnaires brought home by the subjects were Days 2 to 7, with Day 8 to be filled in at the site. The SF-36 scale scores are constructed following the summated ratings of the questions and standardized SF-36 scoring algorithm. Scores range from 0 to 100, with a higher score representing a higher level of functioning. Among items are vigorous activities (running, lifting heavy objects, participating in strenuous sports), moderate activities (moving a table, pushing a vaccum cleaner, bowling, or playing golf) and others, described in the categories below.</description>
        <time_frame>From Baseline at Day -7 to Day 8 after first dose</time_frame>
        <population>The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1437173A Group</title>
            <description>Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Mean SF-36 PF Single Item Scores After First Dose</title>
          <description>Descriptive analysis of the change in mean SF-36 PF single item score from baseline. Changes in the score were measured as Baseline versus mean score over the period Day 2 to Day 8 after the first vaccination. Baseline for dose 1 is defined as the mean of the assessments at Day -7 and Day 1. The post-vaccination completion of SF-36 questionnaires brought home by the subjects were Days 2 to 7, with Day 8 to be filled in at the site. The SF-36 scale scores are constructed following the summated ratings of the questions and standardized SF-36 scoring algorithm. Scores range from 0 to 100, with a higher score representing a higher level of functioning. Among items are vigorous activities (running, lifting heavy objects, participating in strenuous sports), moderate activities (moving a table, pushing a vaccum cleaner, bowling, or playing golf) and others, described in the categories below.</description>
          <population>The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.</population>
          <units>Score units</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="400"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Vigorous activites</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.8" spread="26.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate activites</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" spread="16.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lifting or carrying groceries</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" spread="13.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Climbing several flights</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="17.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Climbing one flight</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" spread="16.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bending, kneeling or stooping</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.8" spread="19.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Walking more than a mile</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" spread="19.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Walking several hundred yards</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" spread="16.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Walking one hundred yards</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" spread="15.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bathing or dressing himself/herself</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="11.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Mean SF-36 PF Single Item Scores After Second Dose</title>
        <description>Descriptive analysis of the change in mean SF-36 PF single item score from baseline. Baseline versus mean score over the period Day 2 to Day 8 after each vaccination. For dose 2 baseline is defined as the mean of the three assessments at Day -7, Day 1 and Day 61 (equivalent to Day 1 for dose 2) The post-vaccination completion of SF-36 questionnaires brought home by the subjects were on Day 2 to Day 7, with Day 8 to be filled in at the site. The SF-36 scale scores are constructed following the summated ratings of the questions and standardized SF-36 scoring algorithm. Scores range from 0 to 100, with a higher score representing a higher level of functioning. Among items are vigorous activities (running, lifting heavy objects, participating in strenuous sports), moderate activities (moving a table, pushing a vaccum cleaner, bowling, or playing golf) and others, described in the categories below.</description>
        <time_frame>From Day -7 to first dose until Day 8 after second dose (equivalent to study Days -7 to 68)</time_frame>
        <population>The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1437173A Group</title>
            <description>Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Mean SF-36 PF Single Item Scores After Second Dose</title>
          <description>Descriptive analysis of the change in mean SF-36 PF single item score from baseline. Baseline versus mean score over the period Day 2 to Day 8 after each vaccination. For dose 2 baseline is defined as the mean of the three assessments at Day -7, Day 1 and Day 61 (equivalent to Day 1 for dose 2) The post-vaccination completion of SF-36 questionnaires brought home by the subjects were on Day 2 to Day 7, with Day 8 to be filled in at the site. The SF-36 scale scores are constructed following the summated ratings of the questions and standardized SF-36 scoring algorithm. Scores range from 0 to 100, with a higher score representing a higher level of functioning. Among items are vigorous activities (running, lifting heavy objects, participating in strenuous sports), moderate activities (moving a table, pushing a vaccum cleaner, bowling, or playing golf) and others, described in the categories below.</description>
          <population>The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.</population>
          <units>Score units</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="389"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Vigorous activities</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" spread="22.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate activities</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.2" spread="16.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Carrying groceries</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" spread="13.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Climbing several flights</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.7" spread="18.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Climbing one flight</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.6" spread="16.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bending or kneeling</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.9" spread="19.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Walking more than mile</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.3" spread="17.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Walking several 100 yards</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.0" spread="15.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Walking 100 Yards</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" spread="13.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bathing/dressing self</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" spread="12.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in SF-36 Role Physical Scores After First Dose</title>
        <description>Descriptive analysis. SF-36 Role physical scores change was measured from baseline score. Baseline versus mean score on Day 8 after first vaccination. Baseline for dose 1 is defined as the mean of the assessments at Day -7 and Day 1. The post-vaccination completion of SF-36 questionnaires brought home by the subjects were on Day 2 to Day 7, with Day 8 to be filled in at the site. The SF-36 scale scores are constructed following the summated ratings of the questions and standardized SF-36 scoring algorithm. Scores range from 0 to 100, with a higher score representing a higher level of functioning.</description>
        <time_frame>From Baseline at Day -7 to Day 8 after first dose</time_frame>
        <population>The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1437173A Group</title>
            <description>Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in SF-36 Role Physical Scores After First Dose</title>
          <description>Descriptive analysis. SF-36 Role physical scores change was measured from baseline score. Baseline versus mean score on Day 8 after first vaccination. Baseline for dose 1 is defined as the mean of the assessments at Day -7 and Day 1. The post-vaccination completion of SF-36 questionnaires brought home by the subjects were on Day 2 to Day 7, with Day 8 to be filled in at the site. The SF-36 scale scores are constructed following the summated ratings of the questions and standardized SF-36 scoring algorithm. Scores range from 0 to 100, with a higher score representing a higher level of functioning.</description>
          <population>The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.</population>
          <units>Score units</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="286"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" spread="14.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in SF-36 Role Physical Scores After Second Dose</title>
        <description>Descriptive analysis. SF-36 Role Physical scores change was measured from baseline score. Changes in the score were measured as Baseline versus Day 8 score after the second vaccination. For dose 2 baseline is defined as the mean of the three assessments at Day -7, Day 1 and Day 61 (equivalent to Day 1 for dose 2) The post-vaccination completion of SF-36 questionnaires brought home by the subjects were on Day 2 to Day 7, with Day 8 to be filled in at the site. The SF-36 scale scores are constructed following the summated ratings of the questions and standardized SF-36 scoring algorithm. Scores range from 0 to 100, with a higher score representing a higher level of functioning.</description>
        <time_frame>From Day -7 to first dose until Day 8 after second dose (equivalent to study Days -7 to 68)</time_frame>
        <population>The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1437173A Group</title>
            <description>Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in SF-36 Role Physical Scores After Second Dose</title>
          <description>Descriptive analysis. SF-36 Role Physical scores change was measured from baseline score. Changes in the score were measured as Baseline versus Day 8 score after the second vaccination. For dose 2 baseline is defined as the mean of the three assessments at Day -7, Day 1 and Day 61 (equivalent to Day 1 for dose 2) The post-vaccination completion of SF-36 questionnaires brought home by the subjects were on Day 2 to Day 7, with Day 8 to be filled in at the site. The SF-36 scale scores are constructed following the summated ratings of the questions and standardized SF-36 scoring algorithm. Scores range from 0 to 100, with a higher score representing a higher level of functioning.</description>
          <population>The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.</population>
          <units>Score units</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="291"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.8" spread="16.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Quality-adjusted Life Year (QALY) After First Dose</title>
        <description>Descriptive analysis. QALY estimation is done from baseline score, based on EQ-5D questionnaires. Baseline versus combined score over the period Day 2 to Day 8 after each vaccination. Baseline for dose 1 is defined as the mean of the assessments at Day -7 and Day 1. The post-vaccination completion of EQ-5D questionnaires brought home by the subjects were on Day 2 to Day 7, with Day 8 to be filled in at the site. The EQ-5D is a generic measure of health status that provides a simple description profile based on 5 items: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, which are used to generate the EQ-5D index utility score. The EQ-5D index utility score ranges from 0 (worst health state) to 1 (perfect health state); 1 reflects the best outcome.</description>
        <time_frame>From Baseline at Day -7 to Day 8 after first dose</time_frame>
        <population>The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1437173A Group</title>
            <description>Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Quality-adjusted Life Year (QALY) After First Dose</title>
          <description>Descriptive analysis. QALY estimation is done from baseline score, based on EQ-5D questionnaires. Baseline versus combined score over the period Day 2 to Day 8 after each vaccination. Baseline for dose 1 is defined as the mean of the assessments at Day -7 and Day 1. The post-vaccination completion of EQ-5D questionnaires brought home by the subjects were on Day 2 to Day 7, with Day 8 to be filled in at the site. The EQ-5D is a generic measure of health status that provides a simple description profile based on 5 items: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, which are used to generate the EQ-5D index utility score. The EQ-5D index utility score ranges from 0 (worst health state) to 1 (perfect health state); 1 reflects the best outcome.</description>
          <population>The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.</population>
          <units>Score units</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="399"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1829" spread="0.55551"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in QALY After Second Dose</title>
        <description>Descriptive analysis. QALY estimation is done from baseline score, based on EQ-5D questionnaires. Baseline versus combined score over the period Day 2 to Day 8 after each vaccination. For dose 2 baseline is defined as the mean of the three assessments at Day -7, Day 1 and Day 61 (equivalent to Day 1 for dose 2) The post-vaccination completion of SF-36 and EQ-5D questionnaires brought home by the subjects were on Day 2 to Day 7, with Day 8 to be filled in at the site. The EQ-5D is a generic measure of health status that provides a simple description profile based on 5 items: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 items are combined to generate health profiles (e.g. 1-no problem/no symptom) and profiles are subsequently converted to a continuous single index utility score (higher scores represent a better quality of life).</description>
        <time_frame>From Day -7 to first dose until Day 8 after second dose (equivalent to study Days -7 to 68)</time_frame>
        <population>The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1437173A Group</title>
            <description>Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in QALY After Second Dose</title>
          <description>Descriptive analysis. QALY estimation is done from baseline score, based on EQ-5D questionnaires. Baseline versus combined score over the period Day 2 to Day 8 after each vaccination. For dose 2 baseline is defined as the mean of the three assessments at Day -7, Day 1 and Day 61 (equivalent to Day 1 for dose 2) The post-vaccination completion of SF-36 and EQ-5D questionnaires brought home by the subjects were on Day 2 to Day 7, with Day 8 to be filled in at the site. The EQ-5D is a generic measure of health status that provides a simple description profile based on 5 items: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 items are combined to generate health profiles (e.g. 1-no problem/no symptom) and profiles are subsequently converted to a continuous single index utility score (higher scores represent a better quality of life).</description>
          <population>The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.</population>
          <units>Score units</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="388"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1128" spread="0.52000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Reactogenicity-triggered Medically Attended Visits After First Dose</title>
        <description>Medical attention and health resource utilization triggered by frequency of reactogenicity events. Healthcare resources included staff involved in the following activities: telephone calls, visit to general practitioner, visit to specialist, visit to emergency room and hospitalizations.</description>
        <time_frame>From Day 1 to Day 7 after first dose</time_frame>
        <population>The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1437173A Group</title>
            <description>Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Reactogenicity-triggered Medically Attended Visits After First Dose</title>
          <description>Medical attention and health resource utilization triggered by frequency of reactogenicity events. Healthcare resources included staff involved in the following activities: telephone calls, visit to general practitioner, visit to specialist, visit to emergency room and hospitalizations.</description>
          <population>The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.</population>
          <units>Visits</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="401"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Attended by Telephone Call</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Attended by General Practicioner</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Attended by Specialist</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Attended by Emergency Room</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Attended by Hospitalization</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Reactogenicity-triggered Medically Attended Visits After Second Dose</title>
        <description>Medical attention and health resource utilization triggered by frequency of reactogenicity events. Healthcare resources included staff involved in the following activities: telephone calls, visit to general practitioner, visit to specialist, visit to emergency room and hospitalizations.</description>
        <time_frame>From Day 1 to Day 7 after second dose</time_frame>
        <population>The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1437173A Group</title>
            <description>Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Reactogenicity-triggered Medically Attended Visits After Second Dose</title>
          <description>Medical attention and health resource utilization triggered by frequency of reactogenicity events. Healthcare resources included staff involved in the following activities: telephone calls, visit to general practitioner, visit to specialist, visit to emergency room and hospitalizations.</description>
          <population>The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.</population>
          <units>Visits</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="391"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Attended by Telephone Call</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Attended by General Practitioner</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Attended by Specialist</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Attended by Emergency Room</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Attended by Hospitalization</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Days of Work Loss for Subjects After First Dose</title>
        <description>Descriptive analysis. Estimation of work loss due to any reaction related to the study vaccine for subjects, expressed in days.</description>
        <time_frame>From Day 1 to Day 7 after first dose</time_frame>
        <population>The analysis was performed on the total number of subjects who reported work loss after the first vaccination and were part of the exposed set, which included all vaccinated subjects with respect to the vaccine actually administered</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1437173A Group</title>
            <description>Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Days of Work Loss for Subjects After First Dose</title>
          <description>Descriptive analysis. Estimation of work loss due to any reaction related to the study vaccine for subjects, expressed in days.</description>
          <population>The analysis was performed on the total number of subjects who reported work loss after the first vaccination and were part of the exposed set, which included all vaccinated subjects with respect to the vaccine actually administered</population>
          <units>Days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Days of Work Loss for Subjects After Second Dose</title>
        <description>Descriptive analysis. Estimation of work loss due to any reaction related to the study vaccine for subjects, expressed in days.</description>
        <time_frame>From Day 1 to Day 7 after second dose</time_frame>
        <population>The analysis was performed on the total number of subjects who reported work loss after the second dose and were part of the exposed set, which included all vaccinated subjects with respect to the vaccine actually administered</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1437173A Group</title>
            <description>Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Days of Work Loss for Subjects After Second Dose</title>
          <description>Descriptive analysis. Estimation of work loss due to any reaction related to the study vaccine for subjects, expressed in days.</description>
          <population>The analysis was performed on the total number of subjects who reported work loss after the second dose and were part of the exposed set, which included all vaccinated subjects with respect to the vaccine actually administered</population>
          <units>Days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Days of Work Loss for Non-dedicated Caregivers After First Dose</title>
        <description>Descriptive analysis. Estimation of work loss of non-dedicated caregivers expressed in days.Data was not reported for this outcome measure as there was no work loss among the non-dedicated caregivers</description>
        <time_frame>From Day 1 to Day 7 after first dose</time_frame>
        <population>The analysis was performed on the total number of non-dedicated caregivers who reported work loss after the first dose and were part of the exposed set, which included all vaccinated subjects with respect to the vaccine actually administered</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1437173A Group</title>
            <description>Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Days of Work Loss for Non-dedicated Caregivers After First Dose</title>
          <description>Descriptive analysis. Estimation of work loss of non-dedicated caregivers expressed in days.Data was not reported for this outcome measure as there was no work loss among the non-dedicated caregivers</description>
          <population>The analysis was performed on the total number of non-dedicated caregivers who reported work loss after the first dose and were part of the exposed set, which included all vaccinated subjects with respect to the vaccine actually administered</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Days of Work Loss for Non-dedicated Caregivers After Second Dose</title>
        <description>Descriptive analysis. Estimation of work loss due to any reaction related to the study vaccine for non-dedicated caregivers, expressed in days. Data was not reported for this outcome measure as there was no work loss among the non-dedicated caregivers</description>
        <time_frame>From Day 1 to Day 7 after second dose</time_frame>
        <population>The analysis was performed on the total number of non-dedicated caregivers who reported work loss after second dose and were a part of the exposed set, which included all vaccinated subjects with respect to the vaccine actually administered.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1437173A Group</title>
            <description>Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Days of Work Loss for Non-dedicated Caregivers After Second Dose</title>
          <description>Descriptive analysis. Estimation of work loss due to any reaction related to the study vaccine for non-dedicated caregivers, expressed in days. Data was not reported for this outcome measure as there was no work loss among the non-dedicated caregivers</description>
          <population>The analysis was performed on the total number of non-dedicated caregivers who reported work loss after second dose and were a part of the exposed set, which included all vaccinated subjects with respect to the vaccine actually administered.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Days of Extra Work for Dedicated Caregivers After First Dose</title>
        <description>Descriptive analysis. Estimation of extra work for dedicated caregivers. Data was not reported for this outcome measure as there was no extra work for the dedicated caregivers</description>
        <time_frame>From Day 1 to Day 7 after first dose</time_frame>
        <population>The analysis was performed on the total number of dedicated caregivers who reported extra work after the first dose and were part of the exposed set, which included all vaccinated subjects with respect to the vaccine actually administered.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1437173A Group</title>
            <description>Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Days of Extra Work for Dedicated Caregivers After First Dose</title>
          <description>Descriptive analysis. Estimation of extra work for dedicated caregivers. Data was not reported for this outcome measure as there was no extra work for the dedicated caregivers</description>
          <population>The analysis was performed on the total number of dedicated caregivers who reported extra work after the first dose and were part of the exposed set, which included all vaccinated subjects with respect to the vaccine actually administered.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Days of Extra Work for Dedicated Caregivers After Second Dose</title>
        <description>Descriptive analysis. Estimation of extra work for dedicated caregivers, expressed in days. Data was not reported for this outcome measure as there was no extra work for the dedicated caregivers</description>
        <time_frame>From Day 1 to Day 7 after second dose</time_frame>
        <population>The analysis was performed on the total number of dedicated caregivers who reported extra work after second dose and were part of the exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1437173A Group</title>
            <description>Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Days of Extra Work for Dedicated Caregivers After Second Dose</title>
          <description>Descriptive analysis. Estimation of extra work for dedicated caregivers, expressed in days. Data was not reported for this outcome measure as there was no extra work for the dedicated caregivers</description>
          <population>The analysis was performed on the total number of dedicated caregivers who reported extra work after second dose and were part of the exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Any and Grade 3 Solicited Local Symptoms After First Dose</title>
        <description>Assessed solicited local symptoms were pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 erythema/swelling =erythema/swelling spreading beyond 100 millimeters (mm) of injection site.</description>
        <time_frame>During a 7-day follow-up period (Day 1 to Day 7) after first dose.</time_frame>
        <population>The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1437173A Group</title>
            <description>Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Any and Grade 3 Solicited Local Symptoms After First Dose</title>
          <description>Assessed solicited local symptoms were pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 erythema/swelling =erythema/swelling spreading beyond 100 millimeters (mm) of injection site.</description>
          <population>The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.</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="400"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="310"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Erythema</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Erythema</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Swelling</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 swelling</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Second Dose</title>
        <description>Assessed solicited local symptoms were pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 erythema/swelling=erythema/swelling spreading beyond 100 millimeters (mm) of injection site.</description>
        <time_frame>During a 7-day follow-up period (Day 1 to Day 7) after second dose.</time_frame>
        <population>The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1437173A Group</title>
            <description>Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Second Dose</title>
          <description>Assessed solicited local symptoms were pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 erythema/swelling=erythema/swelling spreading beyond 100 millimeters (mm) of injection site.</description>
          <population>The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.</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="389"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any Erythema</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Erythema</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="292"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Swelling</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Swelling</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Days With Solicited Local Symptoms After First Dose</title>
        <description>Assessed solicited local symptoms were pain, erythema and swelling.</description>
        <time_frame>During a 7-day follow-up period (Day 1 to Day 7) after first dose.</time_frame>
        <population>The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1437173A Group</title>
            <description>Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Days With Solicited Local Symptoms After First Dose</title>
          <description>Assessed solicited local symptoms were pain, erythema and swelling.</description>
          <population>The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="400"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="310"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" lower_limit="2" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" lower_limit="2" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" lower_limit="2" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Days With Solicited Local Symptoms After Second Dose</title>
        <description>Assessed solicited local symptoms were pain, erythema and swelling.</description>
        <time_frame>During a 7-day follow-up period (Day 1 to Day 7) after second dose.</time_frame>
        <population>The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1437173A Group</title>
            <description>Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Days With Solicited Local Symptoms After Second Dose</title>
          <description>Assessed solicited local symptoms were pain, erythema and swelling.</description>
          <population>The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="292"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="292"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" lower_limit="2" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="87"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" lower_limit="2" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" lower_limit="1" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After First Dose</title>
        <description>Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and temperature [defined as oral, axillary or tympanic temperature equal to or above (≥)37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal everyday activities. Grade 3 temperature=temperature≥39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.</description>
        <time_frame>During a 7-day follow-up period (Day 1 to Day 7) after first dose.</time_frame>
        <population>The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1437173A Group</title>
            <description>Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After First Dose</title>
          <description>Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and temperature [defined as oral, axillary or tympanic temperature equal to or above (≥)37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal everyday activities. Grade 3 temperature=temperature≥39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.</description>
          <population>The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.</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="400"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any Fatigue</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="134"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Fatigue</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Fatigue</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="120"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Gastrointestinal symptoms</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Gastrointestinal symptoms</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Gastrointestinal symptoms</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Headache</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="113"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Headache</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Headache</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Myalgia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="107"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Myalgia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Myalgia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Shivering</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Shivering</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Shivering</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Temperature (oral route)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Temperature(≥39.0 °C)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Temperature</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Second Dose</title>
        <description>Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and temperature [defined as oral, axillary, tympanic temperature ≥ 37.5 °C]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature≥39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.</description>
        <time_frame>During a 7-day follow-up period (Day 1 to Day 7) after second dose.</time_frame>
        <population>The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1437173A Group</title>
            <description>Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Second Dose</title>
          <description>Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and temperature [defined as oral, axillary, tympanic temperature ≥ 37.5 °C]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature≥39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.</description>
          <population>The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.</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="389"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any Fatigue</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="180"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Fatigue</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Fatigue</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="172"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Gastrointestinal symptoms</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Gastrointestinal symptoms</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Gastrointestinal symptoms</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Headache</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="146"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Headache</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Headache</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="127"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Myalgia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="128"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Myalgia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Myalgia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="121"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Shivering</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Shivering</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Shivering</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Temperature (oral route)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Temperature(≥39.0 °C)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Temperature</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Days With Solicited General Symptoms After First Dose</title>
        <description>Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and temperature [defined as oral, axillary or tympanic temperature equal to or above (≥)37.5 degrees Celsius (°C)].</description>
        <time_frame>During a 7-day follow-up period (Day 1 to Day 7) after first dose.</time_frame>
        <population>The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1437173A Group</title>
            <description>Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Days With Solicited General Symptoms After First Dose</title>
          <description>Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and temperature [defined as oral, axillary or tympanic temperature equal to or above (≥)37.5 degrees Celsius (°C)].</description>
          <population>The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="400"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Fatigue</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="134"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" lower_limit="1" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gastrointestinal symptoms</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="1" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="113"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" lower_limit="1" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" lower_limit="1" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Shivering</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="1" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Temperature</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="37"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="1" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Days With Solicited General Symptoms After Second Dose</title>
        <description>Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and temperature [defined as oral, axillary or tympanic temperature equal to or above (≥)37.5 degrees Celsius (°C)].</description>
        <time_frame>During a 7-day follow-up period (Day 1 to Day 7) after second dose.</time_frame>
        <population>The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1437173A Group</title>
            <description>Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Days With Solicited General Symptoms After Second Dose</title>
          <description>Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and temperature [defined as oral, axillary or tympanic temperature equal to or above (≥)37.5 degrees Celsius (°C)].</description>
          <population>The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="180"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Fatigue</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="180"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gastrointestinal symptoms</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="146"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" lower_limit="1" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="128"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Shivering</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="1" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Temperature</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="69"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="1" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)</title>
        <description>An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.&#xD;
Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.</description>
        <time_frame>During a 30-day follow-up period (Day 1 to Day 30) after any vaccination (across doses).</time_frame>
        <population>The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1437173A Group</title>
            <description>Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)</title>
          <description>An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.&#xD;
Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.</description>
          <population>The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.</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="401"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any unsolicited adverse event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="127"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 unsolicited adverse events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related unsolicited adverse events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Any and Related Serious Adverse Events (SAEs) During the Entire Study Period</title>
        <description>SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.</description>
        <time_frame>From Day 1 to study end at Month 14</time_frame>
        <population>The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1437173A Group</title>
            <description>Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Any and Related Serious Adverse Events (SAEs) During the Entire Study Period</title>
          <description>SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.</description>
          <population>The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.</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="401"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs)</title>
        <description>pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.</description>
        <time_frame>From Day 1 to study end at Month 14</time_frame>
        <population>The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1437173A Group</title>
            <description>Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs)</title>
          <description>pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.</description>
          <population>The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.</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="401"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any pIMDs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related pIMDs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Solicited local and general adverse events: Day 1 to 7 after each vaccination. Unsolicited adverse events: From Day 1-30 after each vaccination. SAEs: From Day 1 to study completion (month 14).</time_frame>
      <group_list>
        <group group_id="E1">
          <title>GSK1437173A Group</title>
          <description>Subjects ≥ 50 years of age who received two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>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="2" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="401"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic valve stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Atrioventricular block complete</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Cardiomyopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Stress cardiomyopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Large intestine perforation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Post procedural haematuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Post procedural inflammation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Colon cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Lung adenocarcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Myelodysplastic syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Small intestine adenocarcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>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="370" subjects_at_risk="401"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrilation</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="401"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctivitis allergic</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Eye irritation</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Eye pain</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Keratitis</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorder</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="107" subjects_affected="88" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="401"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Application site erythema</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Application site hyperaesthesia</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="148" subjects_affected="115" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="315" subjects_affected="227" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Feeling cold</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Ill-defined disorder</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Inflammation</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Injection site bruising</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>injection site erythema</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="180" subjects_affected="125" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="603" subjects_affected="341" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Injection site pruritus</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Injection site warmth</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="107" subjects_affected="88" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Injection site swelling</sub_title>
                <counts group_id="E1" events="107" subjects_affected="78" subjects_at_risk="401"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Eye infection staphilococcal</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Fungal infection</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Gastrointestinal viral infection</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Groin abcess</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Nasopharyngithis</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Tooth abcess</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Tooth infection</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="401"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arthropod bite</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Arthropod sting</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Foot fracture</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Injection related reaction</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Meniscus injury</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Procedural dizziness</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Skin laceration</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Superficial injury of eye</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Tooth fracture</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="401"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="401"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Bursitis</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Joint effusion</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Muscle tightness</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Musculoskeletal stiffness</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="238" subjects_affected="169" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Osteoporosis</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Spinal column stenosis</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Tendonitis</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Skin cancer</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="268" subjects_affected="189" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Lethargy</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Sinus headache</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Panic attack</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Stress</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Urinary tract disorder</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Urine odour abnormal</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Pelvic pain</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Paranasal sinus hypersecretion</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Sleep apnoea syndrome</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Dermatitis allergic</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Night sweats</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="401"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Sinus operation</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Flushing</sub_title>
                <description>Unsolicited symptoms</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="401"/>
              </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>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02979639
org study id: 204928
nct id: NCT02979639
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate the impact of reactogenicity of GSK Biologicals'
      HZ/su vaccine on Quality of Life (QoL) in adults ≥ 50 years of age
The study will evaluate the impact of HZ/su vaccination on the QoL, 400 adults ≥ 50 years of
      age (YOA). Subjects will be asked to respond to a series of SF-36 and EQ-5D questionnaires
      before and after vaccination following a 2 month schedule. To estimate the impact of
      reactogenicity on an individual's physical functioning (PF) and QoL, the study will compare
      subject questionnaire responses made during two periods, i.e., pre-vaccination and
      post-vaccination. The difference will be considered to be the effect of vaccination and
      reactogenicity on the PF and QoL. To characterize the study population and determine if
      frailty may influence reactogenicity and consequently the impact on QoL scores, the subjects'
      frailty status will be assessed at the first inclusion visit. In addition to the SF-36 and
      EQ-5D questionnaires, a more complete characterization of the reactogenicity of the vaccine
      will be made by including a detailed collection of the use of healthcare resources and the
      occurrence of symptoms through diary card data collection. Impact on days of work loss, both
      for the subject or for a caregiver, as applicable, will also be assessed.

      Note that as a result of internal change in data standards terminology, the study data
      collected was converted to cDISC and the statistical analysis plan was amended accordingly.
      "Day 0" in the study design was replaced by "Day 1"; consequently, "Day n" was replaced by
      "Day n+1". Thus, the timeframes (Day 0, Day n) of Outcome Measures described in this study
      record are different to that denoted in the full protocol document posted.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in the Short Form 36-item-health Survey (SF36) Physical Functioning (PF) From Baseline Score to Mean Score After First Dose
time frame: From Baseline at Day -7 to Day 8 after first dose
description: Descriptive analysis of the mean and standard deviation (SD) of the change from baseline of the SF-36 physical functioning (PF) score pre- and post dose 1 overall. Changes in the score were measured as Baseline versus mean score over the period Day 2 to Day 8 after first vaccination. Baseline for dose 1 is defined as the mean of the assessments at Day -7 and Day 1. The post-vaccination completion of SF-36 questionnaires brought home by the subjects were Days 2 to 7, with Day 8 to be filled in at the site. The SF-36 scale scores are constructed following the summated ratings of the questions and standardized SF-36 scoring algorithm. Scores range from 0 to 100, with a higher score representing a higher level of functioning.
measure: Change in Mean SF-36 PF Scale Scores From Baseline Score to Mean Score After Second Dose
time frame: From Day -7 to first dose until Day 8 after second dose (equivalent to study Days -7 to 68)
description: Descriptive analysis of the mean and standard deviation of the change from baseline of the SF-36 PF scale score pre and post dose 2 overall. Changes in the score were measured as Baseline versus mean score over the period Day 2 to Day 8 after second vaccination. For dose 2 baseline is defined as the mean of the three assessments at Day -7, Day 1 and Day 61 (Day 1 for dose 2). The post-vaccination completion of SF-36 questionnaires brought home by the subjects were on Day 2 to Day 7, with Day 8 to be filled in at the site. The SF-36 scale scores are constructed following the summated ratings of the questions and standardized SF-36 scoring algorithm. Scores range from 0 to 100, with a higher score representing a higher level of functioning.
measure: Change in Mean SF-36 PF Single Item Scores After First Dose
time frame: From Baseline at Day -7 to Day 8 after first dose
description: Descriptive analysis of the change in mean SF-36 PF single item score from baseline. Changes in the score were measured as Baseline versus mean score over the period Day 2 to Day 8 after the first vaccination. Baseline for dose 1 is defined as the mean of the assessments at Day -7 and Day 1. The post-vaccination completion of SF-36 questionnaires brought home by the subjects were Days 2 to 7, with Day 8 to be filled in at the site. The SF-36 scale scores are constructed following the summated ratings of the questions and standardized SF-36 scoring algorithm. Scores range from 0 to 100, with a higher score representing a higher level of functioning. Among items are vigorous activities (running, lifting heavy objects, participating in strenuous sports), moderate activities (moving a table, pushing a vaccum cleaner, bowling, or playing golf) and others, described in the categories below.
measure: Change in Mean SF-36 PF Single Item Scores After Second Dose
time frame: From Day -7 to first dose until Day 8 after second dose (equivalent to study Days -7 to 68)
description: Descriptive analysis of the change in mean SF-36 PF single item score from baseline. Baseline versus mean score over the period Day 2 to Day 8 after each vaccination. For dose 2 baseline is defined as the mean of the three assessments at Day -7, Day 1 and Day 61 (equivalent to Day 1 for dose 2) The post-vaccination completion of SF-36 questionnaires brought home by the subjects were on Day 2 to Day 7, with Day 8 to be filled in at the site. The SF-36 scale scores are constructed following the summated ratings of the questions and standardized SF-36 scoring algorithm. Scores range from 0 to 100, with a higher score representing a higher level of functioning. Among items are vigorous activities (running, lifting heavy objects, participating in strenuous sports), moderate activities (moving a table, pushing a vaccum cleaner, bowling, or playing golf) and others, described in the categories below.
measure: Change in SF-36 Role Physical Scores After First Dose
time frame: From Baseline at Day -7 to Day 8 after first dose
description: Descriptive analysis. SF-36 Role physical scores change was measured from baseline score. Baseline versus mean score on Day 8 after first vaccination. Baseline for dose 1 is defined as the mean of the assessments at Day -7 and Day 1. The post-vaccination completion of SF-36 questionnaires brought home by the subjects were on Day 2 to Day 7, with Day 8 to be filled in at the site. The SF-36 scale scores are constructed following the summated ratings of the questions and standardized SF-36 scoring algorithm. Scores range from 0 to 100, with a higher score representing a higher level of functioning.
measure: Change in SF-36 Role Physical Scores After Second Dose
time frame: From Day -7 to first dose until Day 8 after second dose (equivalent to study Days -7 to 68)
description: Descriptive analysis. SF-36 Role Physical scores change was measured from baseline score. Changes in the score were measured as Baseline versus Day 8 score after the second vaccination. For dose 2 baseline is defined as the mean of the three assessments at Day -7, Day 1 and Day 61 (equivalent to Day 1 for dose 2) The post-vaccination completion of SF-36 questionnaires brought home by the subjects were on Day 2 to Day 7, with Day 8 to be filled in at the site. The SF-36 scale scores are constructed following the summated ratings of the questions and standardized SF-36 scoring algorithm. Scores range from 0 to 100, with a higher score representing a higher level of functioning.
measure: Change in Quality-adjusted Life Year (QALY) After First Dose
time frame: From Baseline at Day -7 to Day 8 after first dose
description: Descriptive analysis. QALY estimation is done from baseline score, based on EQ-5D questionnaires. Baseline versus combined score over the period Day 2 to Day 8 after each vaccination. Baseline for dose 1 is defined as the mean of the assessments at Day -7 and Day 1. The post-vaccination completion of EQ-5D questionnaires brought home by the subjects were on Day 2 to Day 7, with Day 8 to be filled in at the site. The EQ-5D is a generic measure of health status that provides a simple description profile based on 5 items: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, which are used to generate the EQ-5D index utility score. The EQ-5D index utility score ranges from 0 (worst health state) to 1 (perfect health state); 1 reflects the best outcome.
measure: Change in QALY After Second Dose
time frame: From Day -7 to first dose until Day 8 after second dose (equivalent to study Days -7 to 68)
description: Descriptive analysis. QALY estimation is done from baseline score, based on EQ-5D questionnaires. Baseline versus combined score over the period Day 2 to Day 8 after each vaccination. For dose 2 baseline is defined as the mean of the three assessments at Day -7, Day 1 and Day 61 (equivalent to Day 1 for dose 2) The post-vaccination completion of SF-36 and EQ-5D questionnaires brought home by the subjects were on Day 2 to Day 7, with Day 8 to be filled in at the site. The EQ-5D is a generic measure of health status that provides a simple description profile based on 5 items: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 items are combined to generate health profiles (e.g. 1-no problem/no symptom) and profiles are subsequently converted to a continuous single index utility score (higher scores represent a better quality of life).
measure: Number of Reactogenicity-triggered Medically Attended Visits After First Dose
time frame: From Day 1 to Day 7 after first dose
description: Medical attention and health resource utilization triggered by frequency of reactogenicity events. Healthcare resources included staff involved in the following activities: telephone calls, visit to general practitioner, visit to specialist, visit to emergency room and hospitalizations.
measure: Number of Reactogenicity-triggered Medically Attended Visits After Second Dose
time frame: From Day 1 to Day 7 after second dose
description: Medical attention and health resource utilization triggered by frequency of reactogenicity events. Healthcare resources included staff involved in the following activities: telephone calls, visit to general practitioner, visit to specialist, visit to emergency room and hospitalizations.
measure: Days of Work Loss for Subjects After First Dose
time frame: From Day 1 to Day 7 after first dose
description: Descriptive analysis. Estimation of work loss due to any reaction related to the study vaccine for subjects, expressed in days.
measure: Days of Work Loss for Subjects After Second Dose
time frame: From Day 1 to Day 7 after second dose
description: Descriptive analysis. Estimation of work loss due to any reaction related to the study vaccine for subjects, expressed in days.
measure: Days of Work Loss for Non-dedicated Caregivers After First Dose
time frame: From Day 1 to Day 7 after first dose
description: Descriptive analysis. Estimation of work loss of non-dedicated caregivers expressed in days.Data was not reported for this outcome measure as there was no work loss among the non-dedicated caregivers
measure: Days of Work Loss for Non-dedicated Caregivers After Second Dose
time frame: From Day 1 to Day 7 after second dose
description: Descriptive analysis. Estimation of work loss due to any reaction related to the study vaccine for non-dedicated caregivers, expressed in days. Data was not reported for this outcome measure as there was no work loss among the non-dedicated caregivers
measure: Days of Extra Work for Dedicated Caregivers After First Dose
time frame: From Day 1 to Day 7 after first dose
description: Descriptive analysis. Estimation of extra work for dedicated caregivers. Data was not reported for this outcome measure as there was no extra work for the dedicated caregivers
measure: Days of Extra Work for Dedicated Caregivers After Second Dose
time frame: From Day 1 to Day 7 after second dose
description: Descriptive analysis. Estimation of extra work for dedicated caregivers, expressed in days. Data was not reported for this outcome measure as there was no extra work for the dedicated caregivers
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms After First Dose
time frame: During a 7-day follow-up period (Day 1 to Day 7) after first dose.
description: Assessed solicited local symptoms were pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 erythema/swelling =erythema/swelling spreading beyond 100 millimeters (mm) of injection site.
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Second Dose
time frame: During a 7-day follow-up period (Day 1 to Day 7) after second dose.
description: Assessed solicited local symptoms were pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 erythema/swelling=erythema/swelling spreading beyond 100 millimeters (mm) of injection site.
measure: Number of Days With Solicited Local Symptoms After First Dose
time frame: During a 7-day follow-up period (Day 1 to Day 7) after first dose.
description: Assessed solicited local symptoms were pain, erythema and swelling.
measure: Number of Days With Solicited Local Symptoms After Second Dose
time frame: During a 7-day follow-up period (Day 1 to Day 7) after second dose.
description: Assessed solicited local symptoms were pain, erythema and swelling.
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After First Dose
time frame: During a 7-day follow-up period (Day 1 to Day 7) after first dose.
description: Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and temperature [defined as oral, axillary or tympanic temperature equal to or above (≥)37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal everyday activities. Grade 3 temperature=temperature≥39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Second Dose
time frame: During a 7-day follow-up period (Day 1 to Day 7) after second dose.
description: Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and temperature [defined as oral, axillary, tympanic temperature ≥ 37.5 °C]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature≥39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
measure: Number of Days With Solicited General Symptoms After First Dose
time frame: During a 7-day follow-up period (Day 1 to Day 7) after first dose.
description: Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and temperature [defined as oral, axillary or tympanic temperature equal to or above (≥)37.5 degrees Celsius (°C)].
measure: Number of Days With Solicited General Symptoms After Second Dose
time frame: During a 7-day follow-up period (Day 1 to Day 7) after second dose.
description: Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and temperature [defined as oral, axillary or tympanic temperature equal to or above (≥)37.5 degrees Celsius (°C)].
measure: Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
time frame: During a 30-day follow-up period (Day 1 to Day 30) after any vaccination (across doses).
description: An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
measure: Number of Subjects With Any and Related Serious Adverse Events (SAEs) During the Entire Study Period
time frame: From Day 1 to study end at Month 14
description: SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.
measure: Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs)
time frame: From Day 1 to study end at Month 14
description: pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
arm group label: GSK1437173A Group
arm group type: Experimental
description: Subjects ≥ 50 years of age who will receive two doses of the GSK1437173A vaccine (first dose given at Month 0 and second dose given 2 months later) in this study.
intervention type: Biological
intervention name: GSK Biologicals Herpes Zoster subunit (HZ/su) vaccine (GSK 1437173A)
description: 2 doses administered by intramuscular (IM) injection into the deltoid muscle of the non-dominant arm on a 2 month schedule.
arm group label: GSK1437173A Group
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Herpes Simplex
mesh term: Herpes Zoster
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 