<clinical_study>
  <!-- This xml conforms to an XML Schema at:
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  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03281876</url>
  </required_header>
  <id_info>
    <org_study_id>207489</org_study_id>
    <secondary_id>2017-000880-34</secondary_id>
    <nct_id>NCT03281876</nct_id>
  </id_info>
  <brief_title>A Study to Test if the Vaccine is Working Well in Chronic Obstructive Pulmonary Disease (COPD) Patients Aged 40 to 80 Years Old to Reduce Episodes of Worsening Symptoms and to Gather Further Information on Safety and Immune Response.</brief_title>
  <official_title>An Observer-blind Study to Evaluate the Efficacy, Safety, Reactogenicity and Immunogenicity of the GSK Biologicals' Investigational Vaccine GSK3277511A When Administered to COPD Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to test if the vaccine is working well in COPD patients aged 40&#xD;
      to 80 years old to reduce episodes of worsening symptoms (&quot;exacerbations&quot;) and to gather&#xD;
      further information on safety and immune response.&#xD;
&#xD;
      In the current study, COPD patients with a history of acute exacerbations will receive 2&#xD;
      doses of the investigational vaccine or placebo intramuscularly according to a 0, 2 month&#xD;
      vaccination schedule, in addition to standard care.&#xD;
&#xD;
      The effect of vaccination against two pathogens known to cause exacerbations (Non-typeable&#xD;
      Haemophilus influenza [NTHi] and Moraxella catarrhalis [Mcat]) will be evaluated at&#xD;
      pre-defined timepoints (scheduled study visits).&#xD;
&#xD;
      In addition to the scheduled study visits, additional study visit(s) and/ or phone contact(s)&#xD;
      will take place for each acute exacerbation of COPD occurring from first vaccination up to&#xD;
      study conclusion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this Phase IIB proof-of-concept (POC) study in moderate to very severe COPD&#xD;
      patients (i.e. GOLD grade 2, 3 and 4) aged 40 to 80 years with a history of moderate or&#xD;
      severe acute exacerbations of COPD (AECOPD) in the previous 12 months is to evaluate whether&#xD;
      the NTHi-Mcat vaccine can reduce the frequency of AECOPD in this population and to assess the&#xD;
      vaccine's safety, reactogenicity and immunogenicity.&#xD;
&#xD;
      Several formulations of a vaccine containing the NTHi antigens (low or high formulation)&#xD;
      either non-adjuvanted or combined with different adjuvants (aluminium [Al], adjuvant system)&#xD;
      were already evaluated in two previous Phase I clinical trials (NTHI-002 in healthy adults&#xD;
      aged 18 - 40 years and NTHI-003 in current and former healthy smokers of 50-70 years old).&#xD;
      The investigational vaccines were well-tolerated, with an acceptable safety and&#xD;
      reactogenicity profile. These studies allowed the dose selection of the NTHi antigens (low&#xD;
      formulation) and the adjuvant system currently evaluated for the first time in moderate and&#xD;
      severe COPD patients aged 45 - 81 years in the Phase II study NTHI-004.&#xD;
&#xD;
      The safety, reactogenicity and immunogenicity of different formulations of the NTHi-Mcat&#xD;
      investigational vaccine have been evaluated in the Phase I study in healthy adults aged 19 -&#xD;
      40 years and in current and former smokers aged 50 - 70 years (study NTHI MCAT-001). Based on&#xD;
      results obtained up to 30 days post-Dose 2 from this study, the adjuvanted formulation&#xD;
      containing NTHi proteins PD and PE-PilA and of UspA2 has been selected for evaluation in the&#xD;
      current NTHI MCAT-002 study. Placebo will be used as a control. The NTHi-Mcat investigational&#xD;
      vaccine and placebo will be given on top of standard of care to subjects in the respective&#xD;
      study groups.&#xD;
&#xD;
      In the current study, moderate, severe and very severe COPD patients (i.e. GOLD grade 2, 3&#xD;
      and 4) with a history of AECOPD will receive 2 doses of the NTHi-Mcat investigational vaccine&#xD;
      or placebo intramuscularly (IM) according to a 0, 2 month vaccination schedule, in addition&#xD;
      to standard care.&#xD;
&#xD;
      Scheduled study visits, during which the effect of immunisation against NTHi and Mcat will be&#xD;
      evaluated, will take place at pre-defined timepoints.&#xD;
&#xD;
      In addition to the scheduled study visits, ad hoc AECOPD-driven study visit(s) and/ or phone&#xD;
      contact(s) will take place for each AECOPD occurring from first vaccination up to study&#xD;
      conclusion:&#xD;
&#xD;
        -  An AECOPD visit will be scheduled as soon as possible after the onset of the AECOPD&#xD;
           symptoms (maximum 96 hours after the onset of the symptoms).&#xD;
&#xD;
        -  Follow-up visit(s) and/or phone call(s) will take place to determine the end of the&#xD;
           AECOPD.&#xD;
&#xD;
      Rationale for the protocol amendment:&#xD;
&#xD;
        -  CD8+ T cell component was removed from the secondary endpoint, but kept in the&#xD;
           exploratory/tertiary endpoint. Previous clinical studies have shown that the&#xD;
           investigational NTHi and NTHi-Mcat vaccines do not induce CD8+ T cell responses. This&#xD;
           was observed in all studies performed with the NTHi vaccine and seen in the interim&#xD;
           analysis of NTHi Mcat-001 study.&#xD;
&#xD;
        -  An exclusion criterion was updated to clarify that only subjects with clinically&#xD;
           significant respiratory diseases other than COPD (e.g. clinically significant lung&#xD;
           fibrosis, clinically significant pulmonary embolism) need to be excluded from study&#xD;
           participation.&#xD;
&#xD;
        -  The polymerase chain reaction (PCR) assay for sputum samples was not designed to&#xD;
           discriminate amongst Haemophilus influenzae (Hi) serotypes. Results from AERIS&#xD;
           epidemiological study [Wilkinson, 2017] showed that more than 99% of these bacteria&#xD;
           would be Non-Typeable Haemophilus influenzae (NTHi). Therefore, the protocol was updated&#xD;
           to clarify that the presence of Hi bacteria in sputum during exacerbation will be used&#xD;
           to determine AECOPD associated to NTHi.&#xD;
&#xD;
        -  The list of potential immune mediated diseases was updated (effective June 30th 2017).&#xD;
&#xD;
        -  The 87% confidence interval (CI) was removed from all secondary analyses. This&#xD;
           confidence interval will only be maintained for the primary analysis because the 95% CIs&#xD;
           are underpowered for this study. All other sensitivity analyses on different cohorts&#xD;
           will be described using 95% CIs. As the primary objective will have both 87% and 95%,&#xD;
           the sensitivity analyses can be interpreted with 95% CIs.&#xD;
&#xD;
        -  A Full-Analysis Set (FAS) that corresponds to an intent-to-treat analysis was added. The&#xD;
           FAS will include all randomized subjects who will receive at least 1 vaccine&#xD;
           administration and, as per intention-to-treat principle, a subject in the FAS will be&#xD;
           analysed &quot;as randomized&quot; (i.e. according to the vaccine a subject was planned to receive&#xD;
           irrespectively of his/her real exposure).&#xD;
&#xD;
        -  Cut-off values for anti-PE, anti-PilA and anti-UspA2 antibody ELISAs were updated&#xD;
           following the re-set up of the assays.&#xD;
&#xD;
        -  Additional minor updates were based on the scientific and operational experience gained&#xD;
           from current COPD studies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 27, 2017</start_date>
  <completion_date type="Actual">March 26, 2020</completion_date>
  <primary_completion_date type="Actual">March 26, 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Phase IIB, randomised, observer-blind, placebo-controlled, multi-centric study with two parallel groups.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Data will be collected in an observer-blind manner. By observer-blind, it is meant that during the course of the study, the vaccine recipient and those responsible for the evaluation of any study endpoint (e.g. safety, reactogenicity and efficacy) will all be unaware of whether vaccine or placebo was administered. Each study site is responsible for having a blinding plan. To work in an observer-blind manner, vaccine preparation and administration will be done by authorised medical personnel who will not participate in any of the study clinical evaluation assays. Two teams of study personnel will hence be set up:&#xD;
A team of unblinded personnel (responsible for the preparation and the administration of the vaccines)&#xD;
A team of blinded personnel (responsible for the clinical evaluation of the subjects).</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of Moderate and Severe AECOPD (Any Cause)-Analysis (87% Confidence Interval [CI]), Post-dose 2 and Lasting for 1 Year</measure>
    <time_frame>From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)</time_frame>
    <description>Efficacy of the investigational vaccine was measured by the rate of moderate and severe AECOPD from 1-month post dose 2 up to study end (i.e. rate expressed per year and calculated as the total number of events over the follow-up exposure time). The CIs of the rate is computed using a model which accounts for repeated events. Anthonisen criteria used to detect potential AECOPD: Worsening of 2 or more of the following major symptoms for at least 2 consecutive days: dyspnoea, sputum volume, sputum purulence, OR Worsening of any major symptom together with any of the following minor symptoms for at least 2 consecutive days: sore throat, cold, fever without other cause, increased cough, increased wheeze. Moderate AECOPD requires treatment with systemic corticosteroids and/ or antibiotics. Severe AECOPD requires hospitalization. Confirmation of any AECOPD was as per investigator's judgement.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of Moderate and Severe AECOPD (Any Cause) -Analysis (95% CI), Post-dose 2 and Lasting for 1 Year</measure>
    <time_frame>From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)</time_frame>
    <description>Efficacy of the investigational vaccine was measured by the rate of moderate and severe AECOPD from 1-month post dose 2 up to study end (i.e. rate expressed per year and calculated as the total number of events over the follow-up exposure time). The CIs of the rate is computed using a model which accounts for repeated events. Anthonisen criteria used to detect potential AECOPD: Worsening of 2 or more of the following major symptoms for at least 2 consecutive days: dyspnoea, sputum volume, sputum purulence, OR Worsening of any major symptom together with any of the following minor symptoms for at least 2 consecutive days: sore throat, cold, fever without other cause, increased cough, increased wheeze. Moderate AECOPD requires treatment with systemic corticosteroids and/ or antibiotics. Severe AECOPD requires hospitalization. Confirmation of any AECOPD was as per investigator's judgement.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reported With Each Solicited Local Adverse Event (AE)</measure>
    <time_frame>During the 7-day follow-up period (the day of vaccination + 6 days) after each vaccination administered approximately at Day 1 and Day 61</time_frame>
    <description>Assessed solicited local symptoms were pain, redness and swelling</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reported With Each Solicited General AE</measure>
    <time_frame>During the 7-day follow-up period (the day of vaccination + 6 days) after each vaccination administered approximately at Day 1 and Day 61</time_frame>
    <description>Assessed solicited general symptoms were Chills, fatigue, fever [defined as (oral cavity or axillary) temperature equal to or above (≥) 37.5 degrees Celsius (°C)], gastrointestinal symptoms [nausea, vomiting, diarrhoea and/or abdominal pain], headache and myalgia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reported With Any Unsolicited Adverse Event (AE)</measure>
    <time_frame>During the 30-day follow-up period (the day of vaccination + 29 days) after each vaccination administered approximately at Day 1 and Day 61</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 any solicited symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reported With Any Potential Immune-mediated Diseases (pIMDs)</measure>
    <time_frame>From first vaccination (Day 1) up to Study end (at Day 451)</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>
  <secondary_outcome>
    <measure>Number of Subjects Reported With Any Serious Adverse Event (SAE)</measure>
    <time_frame>From first vaccination (Day 1) up to Study end (at Day 451)</time_frame>
    <description>SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Moderate and Severe AECOPD in Vaccinated and Control Subjects, One Year Follow up Starting 1 Month Post Dose 2, by 3 Months Period</measure>
    <time_frame>During following periods: from 0 to 3 months, from 3 to 6 months, from 6 to 9 months, from 9 to 12 months (observation starting 1 month post-Dose 2)</time_frame>
    <description>The rates of AECOPD were expressed per year and calculated as the total number of events over the follow-up exposure time. The CIs of the rate was computed using a model which accounts for repeated events. The severity of AECOPD can be graded according to the intensity of medical intervention required. Moderate AECOPD= requires treatment with systemic corticosteroids and/or antibiotics. Severe AECOPD= requires hospitalization. The intention of the analysis of the Rate during 3, 6 and 9 months observation starting 1 month post-Dose 2 was to report the rate by 3 months period, so for the periods: 0-3, 3-6, 6-9, 9-12 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Any AECOPD Case in Vaccinated and Control Subjects, One Year Follow up Starting 1 Month Post Dose 2, by 3 Months Period</measure>
    <time_frame>During following periods: from 0 to 3 months, from 3 to 6 months, from 6 to 9 months, from 9 to 12 months, 0-12 months (observation starting 1 month post-Dose 2)</time_frame>
    <description>The rates of any AECOPD were expressed per year and calculated as the total number of events over the follow-up exposure time. The CIs of the rate was computed using a model which accounts for repeated events. The intention of the analysis of the Rate during 3, 6, 9 and 12 months observation starting 1 month post-Dose 2 was to report the rate by 3 months period, so for the periods: 0-3, 3-6, 6-9, 9-12 and 0-12 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exacerbation Rate of Any AECOPD Cases, Classified by Severity, One Year Follow up Starting 1 Month Post Dose 2, by 3 Months Period</measure>
    <time_frame>During following periods: from 0 to 3 months, from 3 to 6 months, from 6 to 9 months, from 9 to 12 months (observation starting 1 month post-Dose 2)</time_frame>
    <description>The exacerbation rate of any AECOPD by severity is the average number of exacerbations for each subject: It is calculated proportionally to the follow-up time per subject and then scaled to the period considered. Mean and standard deviation of the exacerbation rate are given for each period considered. The severity of AECOPD can be graded according to the intensity of medical intervention required. Mild = can be controlled with an increase in dosage of regular medications. Moderate AECOPD= requires treatment with systemic corticosteroids and/or antibiotics. Severe AECOPD= requires hospitalization. The intention of the analysis of the Rate during 3, 6 and 9 months observation starting 1 month post-Dose 2 was to report the rate by 3 months period, so for the periods: 0-3, 3-6, 6-9, 9-12 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With First Moderate or Severe AECOPD</measure>
    <time_frame>From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)</time_frame>
    <description>Number of subjects with first occurrence of moderate or severe episode of AECOPD was reported, in order to compute time to first occurrence and derive the hazard rate using Cox's proportional hazard regression model.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With First AECOPD of Any Severity</measure>
    <time_frame>From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)</time_frame>
    <description>Number of subjects with first occurrence of any episode of AECOPD of any severity was reported, in order to compute time to first occurrence and derive the hazard rate using Cox's proportional hazard regression model.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With First AECOPD Classified by Severity</measure>
    <time_frame>From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)</time_frame>
    <description>Number of subjects with first occurrence of any episode of AECOPD classified by severity was reported, in order to compute time to first occurrence and derive the hazard rate using Cox's proportional hazard regression model.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Days With Moderate and Severe AECOPDs</measure>
    <time_frame>From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)</time_frame>
    <description>The length of each AECOPD was tabulated and presented via descriptive statistics (mean, Standard Deviation) and expressed in Days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Days With AECOPDs of Any Severity</measure>
    <time_frame>From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)</time_frame>
    <description>The length of each AECOPDs was tabulated and presented via descriptive statistics (mean, Standard Deviation).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Days With AECOPDs Classified by Severity</measure>
    <time_frame>From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)</time_frame>
    <description>The length of each AECOPDs by severity was tabulated and presented via descriptive statistics (mean, Standard Deviation).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Non-Typeable Haemophilus Influenzae (NTHi)-Associated and/ or Moraxella Catarrhalis (Mcat)-Associated Moderate and Severe AECOPD</measure>
    <time_frame>From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)</time_frame>
    <description>The rates of AECOPD were expressed per year and calculated as the total number of events over the follow-up exposure time. The CIs of the rate was computed using a model which accounts for repeated events. Respiratory pathogens NTHi and Mcat was determined by Polymerase chain reaction (PCR) analysis in sputum samples.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of NTHi-associated and/ or Mcat-associated AECOPD of Any Severity</measure>
    <time_frame>From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)</time_frame>
    <description>The rates of AECOPD of any severity were expressed per year and calculated as the total number of events over the follow-up exposure time. The CIs of the rate was computed using a model which accounts for repeated events. Respiratory pathogens NTHi and Mcat was determined by polymerase chain reaction (PCR) analysis in sputum samples.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exacerbation Rate of Any NTHi-associated and/ or Mcat-associated AECOPD Cases, Classified by Severity</measure>
    <time_frame>From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)</time_frame>
    <description>The exacerbation rate of any AECOPD by severity is the average number of exacerbations for each subject: it is calculated proportionally to the follow-up time per subject, and then scaled to the period considered. Mean and standard deviation of the exacerbation rate are given for the period considered. Respiratory pathogens NTHi and Mcat was determined PCR analysis in sputum samples</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With First Moderate or Severe NTHi-associated and/or Mcat-associated AECOPD</measure>
    <time_frame>From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)</time_frame>
    <description>Number of subjects with first occurrence of moderate or severe NTHI-associated and/or Mcat-associated AECOPD was reported,in order to compute time to first occurrence and derive the hazard rate using Cox's proportional hazard regression model. Respiratory pathogens NTHi and Mcat was determined PCR analysis in sputum samples.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With First NTHi-associated and/or Mcat-associated AECOPD of Any Severity</measure>
    <time_frame>From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)</time_frame>
    <description>Number of subjects with first occurrence of NTHI-associated and/or Mcat-associated AECOPD of any severity was reported,in order to compute time to first occurrence and derive the hazard rate using Cox's proportional hazard regression model. Respiratory pathogens NTHi and Mcat was determined PCR analysis in sputum samples.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With First NTHi-associated and/or Mcat-associated AECOPD, Classified by Severity</measure>
    <time_frame>From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)</time_frame>
    <description>Number of subjects with first occurrence of NTHI-associated and/or Mcat-associated AECOPD classified by severity was reported, in order to compute time to first occurrence and derive the hazard rate using Cox's proportional hazard regression model. Respiratory pathogens NTHi and Mcat was determined PCR analysis in sputum samples.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Days With Moderate and Severe NTHi-associated and Mcat-associated AECOPD</measure>
    <time_frame>From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)</time_frame>
    <description>The length of each NTHi associated and/or Mcat associated AECOPDs was tabulated and presented via descriptive statistics (mean, Standard Deviation).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Days With NTHi-associated and/or Mcat-associated AECOPDs of Any Severity</measure>
    <time_frame>From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)</time_frame>
    <description>The length of each NTHi associated and/or Mcat associated AECOPDs was tabulated and presented via descriptive statistics (mean, Standard Deviation).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Days With NTHi-associated and/or Mcat-associated AECOPD, Classified by Severity</measure>
    <time_frame>From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)</time_frame>
    <description>The length of each NTHi associated and/or Mcat associated AECOPDs was tabulated and presented via descriptive statistics (mean, Standard Deviation).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-PD Antibody Concentrations as Measured by the Enzyme-Linked Immunosorbent Assay (ELISA)</measure>
    <time_frame>At Day 1, Day 31, Day 61, Day 91, Day 271 and at Day 451</time_frame>
    <description>Anti-Protein D (PD) antibody concentrations as determined by ELISA, and expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EU/mL). For anti-PD antibodies, the cut-off of the assay is 153 ELISA Units per millilitre (EU/mL.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-PE Antibody Concentrations as Measured by ELISA</measure>
    <time_frame>At Day 1, Day 31, Day 61, Day 91, Day 271 and at Day 451</time_frame>
    <description>Anti-Protein E (PE) antibody concentrations as determined by ELISA and expressed as GMCs in EU/mL For Anti-PE antibodies, the cut-off of the assay is 16 EU/mL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-PilA Antibody Concentrations as Measured by ELISA</measure>
    <time_frame>At Day 1, Day 31, Day 61, Day 91, Day 271 and at Day 451</time_frame>
    <description>Anti-Type IV pilus assembly protein (PilA) antibody concentrations as determined by ELISA, and expressed as GMCs in EU/mL. For Anti-PilA antibodies, the cut-off of the assay is 8 EU/mL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-UspA2 Antibody Concentrations as Measured by ELISA</measure>
    <time_frame>At Day 1, Day 31, Day 61, Day 91, Day 271 and at Day 451</time_frame>
    <description>Anti-ubiquitous surface protein A2 of Moraxella catarrhalis (UspA2) aantibody concentrations as determined by ELISA, and expressed as GMCs in EU/mL. For Anti-UspA2 antibodies, the cut-off of the assay is 28 EU/mL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of PD Specific Cluster of Differentiation (CD)4+ T-cells Expressing at Least 2 Markers Among CD40L, IL2, TNF-Alpha, IFN-Gamma, IL-13 and IL-17 Using Background Reduced Frequency Data</measure>
    <time_frame>At Day 1, Day 91, Day 271 and at Day 451</time_frame>
    <description>The ICS staining assay was used to assess cell-mediated immunogenicity (CMI) responses. After Peripheral blood mononuclear cell (PBMC) stimulation with the relevant antigen, the frequency of PD specific CD4+ T-cells expressing selected combination of cytokines such as interleukine-2, 13, 17 (IL-2, IL-13, IL-17), interferon-gamma (IFN-γ), tumour necrosis factor-alpha (TNF-α) and cluster of differentiation 40 ligand (CD40L) are evaluated by flow cytometry and expressed as mean and standard deviation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of PE Specific (CD)4+ T-cells Expressing at Least 2 Markers Among CD40L, IL2, TNF-Alpha, IFN-Gamma, IL-13 and IL-17 Using Background Reduced Frequency Data</measure>
    <time_frame>At Day 1, Day 91, Day 271 and at Day 451</time_frame>
    <description>The ICS staining assay was used to assess CMI responses. After PBMC stimulation with the relevant antigen, the frequency of PE specific CD4+ T-cells expressing selected combination of cytokines such as (IL-2, IL-13, IL-17), IFN-γ, TNF-α and CD40L are evaluated by flow cytometry and expressed as mean and standard deviation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of PilA Specific CD4+ T-cells Expressing at Least 2 Markers Among CD40L, IL2, TNF-Alpha, IFN-Gamma, IL-13 and IL-17 Using Background Reduced Frequency Data</measure>
    <time_frame>At Day 1, Day 91, Day 271 and at Day 451</time_frame>
    <description>The ICS staining assay was used to assess CMI responses. After PBMC stimulation with the relevant antigen, the frequency of PilA specific CD4+ T-cells expressing selected combination of cytokines such as IL-2, IL-13, IL-17, IFN-γ, TNF-α and CD40L are evaluated by flow cytometry and expressed as mean and standard deviation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of UspA2 Specific CD4 + T-cells Expressing at Least 2 Markers Among CD40L, IL2, TNF-Alpha, IFN-Gamma, IL-13 and IL-17 Using Background Reduced Frequency Data</measure>
    <time_frame>At Day 1, Day 91, Day 271 and at Day 451</time_frame>
    <description>The ICS staining assay was used to assess CMI responses. After PBMC stimulation with the relevant antigen, the frequency of UspA2 specific CD4+ T-cells expressing selected combination of cytokines such as IL-2, IL-13, IL-17, IFN-γ, TNF-α and CD40L are evaluated by flow cytometry and expressed as mean and standard deviation.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">606</enrollment>
  <condition>Respiratory Disorders</condition>
  <arm_group>
    <arm_group_label>GSK3277511A Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2) at Day 1 and Day 61.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CONTROL Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Healthy males and females, 40 to 80 years of age, who received two doses of placebo vaccine at Day 1 and Day 61.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>NTHi Mcat investigational vaccine (GSK3277511A)</intervention_name>
    <description>Two doses administered intramuscularly at Day 1 and Day 61 in the deltoid region of the non-dominant arm.</description>
    <arm_group_label>GSK3277511A Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Two doses administered intramuscularly at Day 1 and Day 61 in the deltoid region of the non-dominant arm.</description>
    <arm_group_label>CONTROL 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.&#xD;
&#xD;
          -  Written informed consent obtained from the subject prior to performing any study&#xD;
             specific procedure.&#xD;
&#xD;
          -  A male or female between, and including, 40 and 80 years of age at the time of the&#xD;
             first vaccination.&#xD;
&#xD;
          -  Confirmed diagnosis of COPD with forced expiratory volume in 1 second (FEV1) over&#xD;
             forced vital capacity (FVC) ratio (FEV1/FVC) &lt; 0.7, AND FEV1 &lt; 80% predicted (GOLD 2,&#xD;
             3 and 4).&#xD;
&#xD;
          -  Current or former smoker with a cigarette smoking history of ≥ 10 pack-years.&#xD;
&#xD;
          -  Stable COPD patient* with documented history** of at least 1 moderate or severe AECOPD&#xD;
             within the 12 months before Screening.&#xD;
&#xD;
               -  Patient for whom the last episode of AECOPD is resolved for at least 30 days at&#xD;
                  the time of first vaccination.&#xD;
&#xD;
                    -  A documented history of a COPD exacerbation is a medical record of worsening&#xD;
                       COPD symptoms that required systemic/oral corticosteroids and/or antibiotics&#xD;
                       (for a moderate exacerbation) or hospitalization (for a severe&#xD;
                       exacerbation). Prior use of antibiotics alone does not qualify as an&#xD;
                       exacerbation history unless the use was associated with treatment of&#xD;
                       worsening symptoms of COPD, such as increased dyspnea, sputum volume, or&#xD;
                       sputum purulence. Subject verbal reports are not acceptable.&#xD;
&#xD;
          -  Capable of complying with the daily electronic Diary Card completion throughout the&#xD;
             study period, according to investigator's judgement at Visit 1.&#xD;
&#xD;
          -  Female subjects of non-childbearing potential may be enrolled in the study.&#xD;
             Non-childbearing potential is defined as pre-menarche, current bilateral tubal&#xD;
             ligation or occlusion, hysterectomy, bilateral 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 has a negative&#xD;
        pregnancy test on the day of vaccination, and has agreed to continue adequate contraception&#xD;
        during the entire treatment period and for 2 months after completion of the vaccination&#xD;
        series.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of any investigational or non-registered product other than the study vaccine&#xD;
             during the period starting 30 days before the first dose of study vaccine (Day -29 to&#xD;
             Day 1), or planned use during the study period.&#xD;
&#xD;
          -  Any medical condition that in the judgment of the investigator would make&#xD;
             intramuscular injection unsafe.&#xD;
&#xD;
          -  Administration of immunoglobulins or any blood products within the 3 months preceding&#xD;
             the first dose of study vaccine or planned administration during the study period.&#xD;
&#xD;
          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on&#xD;
             medical history and physical examination.&#xD;
&#xD;
          -  Planned administration/ administration of a vaccine not foreseen by the study protocol&#xD;
             in the period starting 30 days before the first dose and ending 30 days after the last&#xD;
             dose of vaccine, with the exception of any influenza or pneumococcal vaccine which may&#xD;
             be administered ≥15 days preceding or following any study vaccine dose.&#xD;
&#xD;
          -  Concurrently participating in another clinical study, at any time during the study&#xD;
             period, in which the subject has been or will be exposed to an investigational or a&#xD;
             non-investigational vaccine/product.&#xD;
&#xD;
          -  Chronic administration of immunosuppressants or other immune-modifying drugs during&#xD;
             the period starting six months prior to the first vaccine dose (e.g. methotrexate).&#xD;
&#xD;
          -  Administration of systemic corticosteroids within the 30 days before first&#xD;
             vaccination.&#xD;
&#xD;
        Subjects who received systemic corticosteroids within this period may be enrolled at a&#xD;
        later date if enrolment is still open.&#xD;
&#xD;
        Inhaled and topical steroids are allowed.&#xD;
&#xD;
        • Administration of systemic antibiotics within the 30 days before first vaccination.&#xD;
&#xD;
        Subjects who received systemic antibiotics within this period may be enrolled at a later&#xD;
        date if enrolment is still open.&#xD;
&#xD;
          -  Chronic use of antibiotics for prevention of AECOPD (e.g. azithromycin).&#xD;
&#xD;
          -  Acute disease and/or fever at the time of first vaccination. Fever is defined as&#xD;
             temperature ≥37.5°C. The preferred location for measuring temperature in this study&#xD;
             will be the oral cavity or the axilla.&#xD;
&#xD;
        Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection)&#xD;
        without fever may be enrolled at the discretion of the investigator.&#xD;
&#xD;
          -  Oxygen therapy: Use of long-term oxygen therapy (LTOT) described as resting oxygen&#xD;
             therapy &gt;3L/min (Oxygen use ≤3L/min flow is not exclusionary).&#xD;
&#xD;
          -  Planned lung transplantation.&#xD;
&#xD;
          -  Lung resection: Subjects with planned lung volume reduction surgery during the study&#xD;
             or within the 12 months prior to first vaccination.&#xD;
&#xD;
          -  Diagnosis of α-1 antitrypsin deficiency as the underlying cause of COPD.&#xD;
&#xD;
          -  Diagnosed with a respiratory disorder other than COPD at time of enrolment (such as&#xD;
             sarcoidosis, active tuberculosis, clinically significant bronchiectasis, clinically&#xD;
             significant lung fibrosis, clinically significant pulmonary embolism, clinically&#xD;
             significant pneumothorax, current diagnosis of asthma in the opinion of the&#xD;
             investigator), or chest X-ray/ CT scan revealing evidence of clinically significant&#xD;
             abnormalities not believed to be due to the presence of COPD. Subjects with allergic&#xD;
             rhinitis do not need to be excluded and may be enrolled at the discretion of the&#xD;
             investigator.&#xD;
&#xD;
          -  History of immune-mediated disease other than COPD. If the subject has any condition&#xD;
             on the non-exhaustive list of potential immune-mediated diseases defined in the&#xD;
             protocol, they must be excluded unless the aetiology is clearly documented to be&#xD;
             non-immune mediated.&#xD;
&#xD;
          -  Previous vaccination with any vaccine containing NTHi and/ or Mcat antigens.&#xD;
&#xD;
          -  History of any reaction or hypersensitivity likely to be exacerbated by any component&#xD;
             of the vaccines and/ or the bronchodilator used for spirometry assessment during the&#xD;
             study.&#xD;
&#xD;
          -  Contraindication for spirometry testing.&#xD;
&#xD;
          -  Unstable or life threatening cardiac disease: subjects with any of the following at&#xD;
             Screening (Visit 1) would be excluded:&#xD;
&#xD;
        Myocardial infarction or unstable angina in the last 6 months. Unstable or life threatening&#xD;
        cardiac arrhythmia requiring intervention in the last 3 months NYHA Class IV Heart failure&#xD;
&#xD;
          -  Malignancies within the previous 5 years or lymphoproliferative disorder.&#xD;
&#xD;
          -  Any known disease or condition likely to cause death during the study period.&#xD;
&#xD;
          -  Pregnant or lactating female.&#xD;
&#xD;
          -  Current alcoholism and/or drug abuse.&#xD;
&#xD;
          -  Other condition which the investigator judges may put the safety of the subject at&#xD;
             risk through study participation or which may interfere with the study findings.&#xD;
&#xD;
          -  Planned move to a location that will complicate participation in the trial through&#xD;
             study end.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</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>Mesa</city>
        <state>Arizona</state>
        <zip>85213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85018</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85020</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Palm Springs</city>
        <state>California</state>
        <zip>92262</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33765</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Council Bluffs</city>
        <state>Iowa</state>
        <zip>51503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Missoula</city>
        <state>Montana</state>
        <zip>59808</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Neptune</city>
        <state>New Jersey</state>
        <zip>07753</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Mooresville</city>
        <state>North Carolina</state>
        <zip>28117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Corvallis</city>
        <state>Oregon</state>
        <zip>97330</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Medford</city>
        <state>Oregon</state>
        <zip>97504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Erie</city>
        <state>Pennsylvania</state>
        <zip>16508</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Gaffney</city>
        <state>South Carolina</state>
        <zip>29340</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Mount Pleasant</city>
        <state>South Carolina</state>
        <zip>29464</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>Union</city>
        <state>South Carolina</state>
        <zip>29379</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Abingdon</city>
        <state>Virginia</state>
        <zip>24210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23225</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Wenatchee</city>
        <state>Washington</state>
        <zip>98801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Brussels</city>
        <zip>1000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Genk</city>
        <zip>3600</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kortrijk</city>
        <zip>8500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Liège</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2G3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 1M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3K 6R8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Truro</city>
        <state>Nova Scotia</state>
        <zip>B2N 1L2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T1E2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>St-Charles-Borromée</city>
        <state>Quebec</state>
        <zip>J6E 2B4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Quebec</city>
        <zip>G1V 4G5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Brest Cedex</city>
        <zip>29609</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Créteil cedex</city>
        <zip>94010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Marseille cedex 08</city>
        <zip>13285</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Montpellier cedex 5</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Frankfurt</city>
        <state>Hessen</state>
        <zip>60389</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Frankfurt</city>
        <state>Hessen</state>
        <zip>60596</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Immenhausen</city>
        <state>Hessen</state>
        <zip>34376</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Grosshansdorf</city>
        <state>Schleswig-Holstein</state>
        <zip>22927</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Luebeck</city>
        <state>Schleswig-Holstein</state>
        <zip>23552</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Magdeburg</city>
        <zip>39120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Cona (FE)</city>
        <state>Emilia-Romagna</state>
        <zip>44124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Parma</city>
        <state>Emilia-Romagna</state>
        <zip>43100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20142</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Monza</city>
        <state>Lombardia</state>
        <zip>20900</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Negrar</city>
        <state>Veneto</state>
        <zip>37024</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Barcelona</city>
        <zip>08003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Centelles (Barcelona)</city>
        <zip>08540</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Elda</city>
        <zip>03600</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>La Roca Del Valles (Barcelona)</city>
        <zip>08430</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Pozuelo De Alarcón/Madrid</city>
        <zip>28223</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Vic</city>
        <zip>28500</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Portsmouth</city>
        <state>Hampshire</state>
        <zip>PO6 3LY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bradford</city>
        <zip>BD9 6RJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Dundee</city>
        <zip>DD1 9SY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Edinburgh</city>
        <zip>EH16 4SA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>High Heaton, Newcastle Upon Tyne</city>
        <zip>NE7 7DN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Southampton</city>
        <zip>SO16 6YD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Canada</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <results_first_submitted>November 17, 2020</results_first_submitted>
  <results_first_submitted_qc>January 8, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">January 11, 2021</results_first_posted>
  <last_update_submitted>January 8, 2021</last_update_submitted>
  <last_update_submitted_qc>January 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Immunogenicity</keyword>
  <keyword>Vaccination</keyword>
  <keyword>Chronic Obstructive Pulmonary Disease</keyword>
  <keyword>Non-typeable Haemophilus influenzae</keyword>
  <keyword>Acute exacerbation of COPD</keyword>
  <keyword>Moraxella catarrhalis</keyword>
  <keyword>Efficacy</keyword>
  <keyword>Safety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiration Disorders</mesh_term>
    <mesh_term>Respiratory Tract Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>IPD for this study will be made available via the Clinical Study Data Request site.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study</ipd_time_frame>
    <ipd_access_criteria>Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.</ipd_access_criteria>
    <ipd_url>https://clinicalstudydatarequest.com</ipd_url>
  </patient_data>
  <provided_document_section>
    <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>March 27, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/76/NCT03281876/Prot_000.pdf</document_url>
    </provided_document>
    <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>November 29, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/76/NCT03281876/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>GSK3277511A Group</title>
          <description>Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61</description>
        </group>
        <group group_id="P2">
          <title>Control Group</title>
          <description>Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="304"/>
                <participants group_id="P2" count="302"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="281"/>
                <participants group_id="P2" count="263"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="39"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>MIGRATED / MOVED FROM THE STUDY AREA</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>OTHER</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>GSK3277511A Group</title>
          <description>Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61</description>
        </group>
        <group group_id="B2">
          <title>Control Group</title>
          <description>Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="304"/>
            <count group_id="B2" value="302"/>
            <count group_id="B3" value="606"/>
          </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="65.7" spread="7.5"/>
                    <measurement group_id="B2" value="66.3" spread="7.3"/>
                    <measurement group_id="B3" value="66.0" spread="7.4"/>
                  </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="120"/>
                    <measurement group_id="B2" value="125"/>
                    <measurement group_id="B3" value="245"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="184"/>
                    <measurement group_id="B2" value="177"/>
                    <measurement group_id="B3" value="361"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>American Indian Or Alaska Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian - Central / South Asian Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian - South East Asian Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black Or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White - Arabic / North African Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White - Caucasian / European Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="294"/>
                    <measurement group_id="B2" value="296"/>
                    <measurement group_id="B3" value="590"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Rate of Moderate and Severe AECOPD (Any Cause)-Analysis (87% Confidence Interval [CI]), Post-dose 2 and Lasting for 1 Year</title>
        <description>Efficacy of the investigational vaccine was measured by the rate of moderate and severe AECOPD from 1-month post dose 2 up to study end (i.e. rate expressed per year and calculated as the total number of events over the follow-up exposure time). The CIs of the rate is computed using a model which accounts for repeated events. Anthonisen criteria used to detect potential AECOPD: Worsening of 2 or more of the following major symptoms for at least 2 consecutive days: dyspnoea, sputum volume, sputum purulence, OR Worsening of any major symptom together with any of the following minor symptoms for at least 2 consecutive days: sore throat, cold, fever without other cause, increased cough, increased wheeze. Moderate AECOPD requires treatment with systemic corticosteroids and/ or antibiotics. Severe AECOPD requires hospitalization. Confirmation of any AECOPD was as per investigator's judgement.</description>
        <time_frame>From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)</time_frame>
        <population>The analysis was performed on the Modified Total Vaccinated cohort, which includes all vaccinated subjects with 2 documented study vaccine administrations with respect to the vaccine actually administered.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3277511A Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Moderate and Severe AECOPD (Any Cause)-Analysis (87% Confidence Interval [CI]), Post-dose 2 and Lasting for 1 Year</title>
          <description>Efficacy of the investigational vaccine was measured by the rate of moderate and severe AECOPD from 1-month post dose 2 up to study end (i.e. rate expressed per year and calculated as the total number of events over the follow-up exposure time). The CIs of the rate is computed using a model which accounts for repeated events. Anthonisen criteria used to detect potential AECOPD: Worsening of 2 or more of the following major symptoms for at least 2 consecutive days: dyspnoea, sputum volume, sputum purulence, OR Worsening of any major symptom together with any of the following minor symptoms for at least 2 consecutive days: sore throat, cold, fever without other cause, increased cough, increased wheeze. Moderate AECOPD requires treatment with systemic corticosteroids and/ or antibiotics. Severe AECOPD requires hospitalization. Confirmation of any AECOPD was as per investigator's judgement.</description>
          <population>The analysis was performed on the Modified Total Vaccinated cohort, which includes all vaccinated subjects with 2 documented study vaccine administrations with respect to the vaccine actually administered.</population>
          <units>exacerbations per person-year</units>
          <param>Number</param>
          <dispersion>87% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="278"/>
                <count group_id="O2" value="292"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.22" lower_limit="1.09" upper_limit="1.36"/>
                    <measurement group_id="O2" value="1.17" lower_limit="1.06" upper_limit="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>To assess efficacy of the investigational vaccine as compared to the placebo control with respect to the rate of moderate and severe AECOPDs</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Vaccine Efficacy is defined as 1 minus the risk ratio (Rvacc / Rcon) based on the number of moderate and severe AECOPD observed in 1 year , with Rvacc = average yearly incidence rate of AECOPD events per subject in the GSK3277511A Group and Rcon = average yearly incidence rate of AECOPD events per subject in the Control group. The objective is to be considered a success if the lower limit of the 87% CI is above 0%.</non_inferiority_desc>
            <p_value>0.8157</p_value>
            <method>Negative Binomial regression</method>
            <method_desc>Negative Binomial model with arm, country, gold grade, history of exacerbation and age category as covariates and log time as offset variable</method_desc>
            <param_type>Other: Vaccine Efficacy rate</param_type>
            <param_value>-2.26</param_value>
            <ci_percent>87</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-18.27</ci_lower_limit>
            <ci_upper_limit>11.58</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Rate of Moderate and Severe AECOPD (Any Cause) -Analysis (95% CI), Post-dose 2 and Lasting for 1 Year</title>
        <description>Efficacy of the investigational vaccine was measured by the rate of moderate and severe AECOPD from 1-month post dose 2 up to study end (i.e. rate expressed per year and calculated as the total number of events over the follow-up exposure time). The CIs of the rate is computed using a model which accounts for repeated events. Anthonisen criteria used to detect potential AECOPD: Worsening of 2 or more of the following major symptoms for at least 2 consecutive days: dyspnoea, sputum volume, sputum purulence, OR Worsening of any major symptom together with any of the following minor symptoms for at least 2 consecutive days: sore throat, cold, fever without other cause, increased cough, increased wheeze. Moderate AECOPD requires treatment with systemic corticosteroids and/ or antibiotics. Severe AECOPD requires hospitalization. Confirmation of any AECOPD was as per investigator's judgement.</description>
        <time_frame>From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)</time_frame>
        <population>The analysis was performed on the Modified Total Vaccinated cohort, which includes all vaccinated subjects with 2 documented study vaccine administrations with respect to the vaccine actually administered.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3277511A Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Moderate and Severe AECOPD (Any Cause) -Analysis (95% CI), Post-dose 2 and Lasting for 1 Year</title>
          <description>Efficacy of the investigational vaccine was measured by the rate of moderate and severe AECOPD from 1-month post dose 2 up to study end (i.e. rate expressed per year and calculated as the total number of events over the follow-up exposure time). The CIs of the rate is computed using a model which accounts for repeated events. Anthonisen criteria used to detect potential AECOPD: Worsening of 2 or more of the following major symptoms for at least 2 consecutive days: dyspnoea, sputum volume, sputum purulence, OR Worsening of any major symptom together with any of the following minor symptoms for at least 2 consecutive days: sore throat, cold, fever without other cause, increased cough, increased wheeze. Moderate AECOPD requires treatment with systemic corticosteroids and/ or antibiotics. Severe AECOPD requires hospitalization. Confirmation of any AECOPD was as per investigator's judgement.</description>
          <population>The analysis was performed on the Modified Total Vaccinated cohort, which includes all vaccinated subjects with 2 documented study vaccine administrations with respect to the vaccine actually administered.</population>
          <units>exacerbations per person-year</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="278"/>
                <count group_id="O2" value="292"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.22" lower_limit="1.05" upper_limit="1.41"/>
                    <measurement group_id="O2" value="1.17" lower_limit="1.02" upper_limit="1.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>To assess efficacy of the investigational vaccine as compared to the placebo control with respect to the rate of moderate and severe AECOPDs</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Vaccine Efficacy is defined as 1 minus the risk ratio (Rvacc / Rcon) based on the number of moderate and severe AECOPD observed in 1 year , with Rvacc = average yearly incidence rate of AECOPD events per subject in the GSK3277511A Group and Rcon = average yearly incidence rate of AECOPD events per subject in the Control group.</non_inferiority_desc>
            <p_value>0.8157</p_value>
            <method>Negative Binomial regression</method>
            <method_desc>Negative Binomial model with arm, country, gold grade, history of exacerbation and age category as covariates and log time as offset variable</method_desc>
            <param_type>Other: Vaccine Efficacy rate</param_type>
            <param_value>-2.26</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-23.45</ci_lower_limit>
            <ci_upper_limit>15.29</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reported With Each Solicited Local Adverse Event (AE)</title>
        <description>Assessed solicited local symptoms were pain, redness and swelling</description>
        <time_frame>During the 7-day follow-up period (the day of vaccination + 6 days) after each vaccination administered approximately at Day 1 and Day 61</time_frame>
        <population>The analysis was performed on the Total Vaccinated cohort which includes all vaccinated subjects with at least one documented study vaccine administration and who provided solicited safey data.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3277511A Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reported With Each Solicited Local Adverse Event (AE)</title>
          <description>Assessed solicited local symptoms were pain, redness and swelling</description>
          <population>The analysis was performed on the Total Vaccinated cohort which includes all vaccinated subjects with at least one documented study vaccine administration and who provided solicited safey data.</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="292"/>
                <count group_id="O2" value="291"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pain, Dose 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="292"/>
                    <count group_id="O2" value="291"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="153"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain, Dose 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="265"/>
                    <count group_id="O2" value="273"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="163"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Redness (mm), Dose 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="292"/>
                    <count group_id="O2" value="291"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Redness (mm), Dose 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="265"/>
                    <count group_id="O2" value="273"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling (mm), Dose 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="292"/>
                    <count group_id="O2" value="291"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling (mm), Dose 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="265"/>
                    <count group_id="O2" value="273"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reported With Each Solicited General AE</title>
        <description>Assessed solicited general symptoms were Chills, fatigue, fever [defined as (oral cavity or axillary) temperature equal to or above (≥) 37.5 degrees Celsius (°C)], gastrointestinal symptoms [nausea, vomiting, diarrhoea and/or abdominal pain], headache and myalgia.</description>
        <time_frame>During the 7-day follow-up period (the day of vaccination + 6 days) after each vaccination administered approximately at Day 1 and Day 61</time_frame>
        <population>The analysis was performed on the Total Vaccinated cohort which includes all vaccinated subjects with at least one documented study vaccine administration and who provided solicited safey data.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3277511A Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reported With Each Solicited General AE</title>
          <description>Assessed solicited general symptoms were Chills, fatigue, fever [defined as (oral cavity or axillary) temperature equal to or above (≥) 37.5 degrees Celsius (°C)], gastrointestinal symptoms [nausea, vomiting, diarrhoea and/or abdominal pain], headache and myalgia.</description>
          <population>The analysis was performed on the Total Vaccinated cohort which includes all vaccinated subjects with at least one documented study vaccine administration and who provided solicited safey data.</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="292"/>
                <count group_id="O2" value="291"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Chills, Dose 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="292"/>
                    <count group_id="O2" value="291"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chills, Dose 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="265"/>
                    <count group_id="O2" value="273"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue, Dose 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="292"/>
                    <count group_id="O2" value="291"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="157"/>
                    <measurement group_id="O2" value="167"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue, Dose 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="265"/>
                    <count group_id="O2" value="273"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="136"/>
                    <measurement group_id="O2" value="130"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever, Dose 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="292"/>
                    <count group_id="O2" value="291"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever, Dose 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="265"/>
                    <count group_id="O2" value="273"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gastrointestinal symptoms, Dose 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="292"/>
                    <count group_id="O2" value="291"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47"/>
                    <measurement group_id="O2" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gastrointestinal symptoms, Dose 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="265"/>
                    <count group_id="O2" value="273"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache, Dose 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="292"/>
                    <count group_id="O2" value="291"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98"/>
                    <measurement group_id="O2" value="76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache, Dose 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="265"/>
                    <count group_id="O2" value="273"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75"/>
                    <measurement group_id="O2" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia, Dose 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="292"/>
                    <count group_id="O2" value="291"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78"/>
                    <measurement group_id="O2" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia, Dose 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="265"/>
                    <count group_id="O2" value="273"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74"/>
                    <measurement group_id="O2" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reported With Any Unsolicited Adverse Event (AE)</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 any solicited symptoms.</description>
        <time_frame>During the 30-day follow-up period (the day of vaccination + 29 days) after each vaccination administered approximately at Day 1 and Day 61</time_frame>
        <population>The analysis was performed on the Total Vaccinated cohort which includes all vaccinated subjects with at least one documented study vaccine administration and who provided unsolicited safety data.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3277511A Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reported With Any Unsolicited Adverse Event (AE)</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 any solicited symptoms.</description>
          <population>The analysis was performed on the Total Vaccinated cohort which includes all vaccinated subjects with at least one documented study vaccine administration and who provided unsolicited safety data.</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="304"/>
                <count group_id="O2" value="302"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="110"/>
                    <measurement group_id="O2" value="103"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reported With Any 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 first vaccination (Day 1) up to Study end (at Day 451)</time_frame>
        <population>The analysis was performed on the Total Vaccinated cohort which includes all vaccinated subjects with at least one documented study vaccine administration and who provided safety data.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3277511A Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reported With Any 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 Total Vaccinated cohort which includes all vaccinated subjects with at least one documented study vaccine administration and who provided safety data.</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="304"/>
                <count group_id="O2" value="302"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reported With Any Serious Adverse Event (SAE)</title>
        <description>SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity</description>
        <time_frame>From first vaccination (Day 1) up to Study end (at Day 451)</time_frame>
        <population>The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects with at least one documented study vaccine administration and who provided safety data.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3277511A Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reported With Any Serious Adverse Event (SAE)</title>
          <description>SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity</description>
          <population>The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects with at least one documented study vaccine administration and who provided safety data.</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="304"/>
                <count group_id="O2" value="302"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89"/>
                    <measurement group_id="O2" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of Moderate and Severe AECOPD in Vaccinated and Control Subjects, One Year Follow up Starting 1 Month Post Dose 2, by 3 Months Period</title>
        <description>The rates of AECOPD were expressed per year and calculated as the total number of events over the follow-up exposure time. The CIs of the rate was computed using a model which accounts for repeated events. The severity of AECOPD can be graded according to the intensity of medical intervention required. Moderate AECOPD= requires treatment with systemic corticosteroids and/or antibiotics. Severe AECOPD= requires hospitalization. The intention of the analysis of the Rate during 3, 6 and 9 months observation starting 1 month post-Dose 2 was to report the rate by 3 months period, so for the periods: 0-3, 3-6, 6-9, 9-12 months.</description>
        <time_frame>During following periods: from 0 to 3 months, from 3 to 6 months, from 6 to 9 months, from 9 to 12 months (observation starting 1 month post-Dose 2)</time_frame>
        <population>The analysis was performed on the Modified Total Vaccinated cohort, which includes all vaccinated subjects with 2 documented study vaccine administrations with respect to the vaccine actually administered.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3277511A Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Moderate and Severe AECOPD in Vaccinated and Control Subjects, One Year Follow up Starting 1 Month Post Dose 2, by 3 Months Period</title>
          <description>The rates of AECOPD were expressed per year and calculated as the total number of events over the follow-up exposure time. The CIs of the rate was computed using a model which accounts for repeated events. The severity of AECOPD can be graded according to the intensity of medical intervention required. Moderate AECOPD= requires treatment with systemic corticosteroids and/or antibiotics. Severe AECOPD= requires hospitalization. The intention of the analysis of the Rate during 3, 6 and 9 months observation starting 1 month post-Dose 2 was to report the rate by 3 months period, so for the periods: 0-3, 3-6, 6-9, 9-12 months.</description>
          <population>The analysis was performed on the Modified Total Vaccinated cohort, which includes all vaccinated subjects with 2 documented study vaccine administrations with respect to the vaccine actually administered.</population>
          <units>exacerbations per person-year</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="278"/>
                <count group_id="O2" value="292"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>FROM 0 TO 3 MONTHS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="278"/>
                    <count group_id="O2" value="292"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.35" lower_limit="1.1" upper_limit="1.66"/>
                    <measurement group_id="O2" value="1.15" lower_limit="0.92" upper_limit="1.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FROM 3 TO 6 MONTHS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="274"/>
                    <count group_id="O2" value="288"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.33" lower_limit="1.08" upper_limit="1.63"/>
                    <measurement group_id="O2" value="1.44" lower_limit="1.19" upper_limit="1.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FROM 6 TO 9 MONTHS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="272"/>
                    <count group_id="O2" value="280"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.36" lower_limit="1.11" upper_limit="1.67"/>
                    <measurement group_id="O2" value="1.19" lower_limit="0.96" upper_limit="1.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FROM 9 TO 12 MONTHS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="271"/>
                    <count group_id="O2" value="272"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.87" lower_limit="0.69" upper_limit="1.11"/>
                    <measurement group_id="O2" value="0.9" lower_limit="0.71" upper_limit="1.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of Any AECOPD Case in Vaccinated and Control Subjects, One Year Follow up Starting 1 Month Post Dose 2, by 3 Months Period</title>
        <description>The rates of any AECOPD were expressed per year and calculated as the total number of events over the follow-up exposure time. The CIs of the rate was computed using a model which accounts for repeated events. The intention of the analysis of the Rate during 3, 6, 9 and 12 months observation starting 1 month post-Dose 2 was to report the rate by 3 months period, so for the periods: 0-3, 3-6, 6-9, 9-12 and 0-12 months.</description>
        <time_frame>During following periods: from 0 to 3 months, from 3 to 6 months, from 6 to 9 months, from 9 to 12 months, 0-12 months (observation starting 1 month post-Dose 2)</time_frame>
        <population>The analysis was performed on the Modified Total Vaccinated cohort, which includes all vaccinated subjects with 2 documented study vaccine administrations with respect to the vaccine actually administered.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3277511A Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Any AECOPD Case in Vaccinated and Control Subjects, One Year Follow up Starting 1 Month Post Dose 2, by 3 Months Period</title>
          <description>The rates of any AECOPD were expressed per year and calculated as the total number of events over the follow-up exposure time. The CIs of the rate was computed using a model which accounts for repeated events. The intention of the analysis of the Rate during 3, 6, 9 and 12 months observation starting 1 month post-Dose 2 was to report the rate by 3 months period, so for the periods: 0-3, 3-6, 6-9, 9-12 and 0-12 months.</description>
          <population>The analysis was performed on the Modified Total Vaccinated cohort, which includes all vaccinated subjects with 2 documented study vaccine administrations with respect to the vaccine actually administered.</population>
          <units>exacerbations per person-year</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="278"/>
                <count group_id="O2" value="292"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>FROM 0 TO 3 MONTHS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="278"/>
                    <count group_id="O2" value="292"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.47" lower_limit="1.21" upper_limit="1.79"/>
                    <measurement group_id="O2" value="1.33" lower_limit="1.09" upper_limit="1.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FROM 3 TO 6 MONTHS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="274"/>
                    <count group_id="O2" value="288"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.56" lower_limit="1.29" upper_limit="1.89"/>
                    <measurement group_id="O2" value="1.56" lower_limit="1.29" upper_limit="1.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FROM 6 TO 9 MONTHS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="272"/>
                    <count group_id="O2" value="280"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.49" lower_limit="1.23" upper_limit="1.82"/>
                    <measurement group_id="O2" value="1.29" lower_limit="1.05" upper_limit="1.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FROM 9 TO 12 MONTHS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="271"/>
                    <count group_id="O2" value="272"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.98" lower_limit="0.78" upper_limit="1.22"/>
                    <measurement group_id="O2" value="1.04" lower_limit="0.84" upper_limit="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>From 0 TO 12 MONTHS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="278"/>
                    <count group_id="O2" value="292"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.36" lower_limit="1.19" upper_limit="1.57"/>
                    <measurement group_id="O2" value="1.31" lower_limit="1.15" upper_limit="1.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>To assess efficacy of the investigational vaccine as compared to the placebo control with respect to the rate of AECOPDs of any severity- upto 12 months follow up period</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Vaccine Efficacy is defined as 1 minus the risk ratio (Rvacc / Rcon) based on the number of moderate and severe AECOPD observed in 1 year , with Rvacc = average yearly incidence rate of AECOPD events per subject in the GSK3277511A Group and Rcon = average yearly incidence rate of AECOPD events per subject in the control group.</non_inferiority_desc>
            <p_value>0.7700</p_value>
            <method>Negative Binomial regression</method>
            <param_type>Vaccine efficacy rate</param_type>
            <param_value>-2.72</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-22.95</ci_lower_limit>
            <ci_upper_limit>14.19</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Exacerbation Rate of Any AECOPD Cases, Classified by Severity, One Year Follow up Starting 1 Month Post Dose 2, by 3 Months Period</title>
        <description>The exacerbation rate of any AECOPD by severity is the average number of exacerbations for each subject: It is calculated proportionally to the follow-up time per subject and then scaled to the period considered. Mean and standard deviation of the exacerbation rate are given for each period considered. The severity of AECOPD can be graded according to the intensity of medical intervention required. Mild = can be controlled with an increase in dosage of regular medications. Moderate AECOPD= requires treatment with systemic corticosteroids and/or antibiotics. Severe AECOPD= requires hospitalization. The intention of the analysis of the Rate during 3, 6 and 9 months observation starting 1 month post-Dose 2 was to report the rate by 3 months period, so for the periods: 0-3, 3-6, 6-9, 9-12 months.</description>
        <time_frame>During following periods: from 0 to 3 months, from 3 to 6 months, from 6 to 9 months, from 9 to 12 months (observation starting 1 month post-Dose 2)</time_frame>
        <population>The analysis was performed on the Modified Total Vaccinated cohort, which includes all vaccinated subjects with 2 documented study vaccine administrations with respect to the vaccine actually administered.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3277511A Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.</description>
          </group>
        </group_list>
        <measure>
          <title>Exacerbation Rate of Any AECOPD Cases, Classified by Severity, One Year Follow up Starting 1 Month Post Dose 2, by 3 Months Period</title>
          <description>The exacerbation rate of any AECOPD by severity is the average number of exacerbations for each subject: It is calculated proportionally to the follow-up time per subject and then scaled to the period considered. Mean and standard deviation of the exacerbation rate are given for each period considered. The severity of AECOPD can be graded according to the intensity of medical intervention required. Mild = can be controlled with an increase in dosage of regular medications. Moderate AECOPD= requires treatment with systemic corticosteroids and/or antibiotics. Severe AECOPD= requires hospitalization. The intention of the analysis of the Rate during 3, 6 and 9 months observation starting 1 month post-Dose 2 was to report the rate by 3 months period, so for the periods: 0-3, 3-6, 6-9, 9-12 months.</description>
          <population>The analysis was performed on the Modified Total Vaccinated cohort, which includes all vaccinated subjects with 2 documented study vaccine administrations with respect to the vaccine actually administered.</population>
          <units>exacerbations per person</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="278"/>
                <count group_id="O2" value="292"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>MILD, FROM 0 TO 3 MONTHS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="278"/>
                    <count group_id="O2" value="292"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.02" spread="0.15"/>
                    <measurement group_id="O2" value="0.03" spread="0.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MILD, FROM 3 TO 6 MONTHS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="274"/>
                    <count group_id="O2" value="288"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.05" spread="0.24"/>
                    <measurement group_id="O2" value="0.02" spread="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MILD, FROM 6 TO 9 MONTHS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="272"/>
                    <count group_id="O2" value="280"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.03" spread="0.19"/>
                    <measurement group_id="O2" value="0.03" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MILD, FROM 9 TO 12 MONTHS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="271"/>
                    <count group_id="O2" value="272"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.03" spread="0.17"/>
                    <measurement group_id="O2" value="0.03" spread="0.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MODERATE, FROM 0 TO 3 MONTHS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="278"/>
                    <count group_id="O2" value="292"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.29" spread="0.62"/>
                    <measurement group_id="O2" value="0.23" spread="0.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MODERATE, FROM 3 TO 6 MONTHS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="274"/>
                    <count group_id="O2" value="288"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.27" spread="0.51"/>
                    <measurement group_id="O2" value="0.3" spread="0.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MODERATE, FROM 6 TO 9 MONTHS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="272"/>
                    <count group_id="O2" value="280"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="0.56"/>
                    <measurement group_id="O2" value="0.25" spread="0.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MODERATE, FROM 9 TO 12 MONTHS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="271"/>
                    <count group_id="O2" value="272"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="0.44"/>
                    <measurement group_id="O2" value="0.17" spread="0.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SEVERE, FROM 0 TO 3 MONTHS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="278"/>
                    <count group_id="O2" value="292"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.04" spread="0.24"/>
                    <measurement group_id="O2" value="0.05" spread="0.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SEVERE, FROM 3 TO 6 MONTHS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="274"/>
                    <count group_id="O2" value="288"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.05" spread="0.22"/>
                    <measurement group_id="O2" value="0.06" spread="0.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SEVERE, FROM 6 TO 9 MONTHS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="272"/>
                    <count group_id="O2" value="280"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.05" spread="0.29"/>
                    <measurement group_id="O2" value="0.05" spread="0.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SEVERE, FROM 9 TO 12 MONTHS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="271"/>
                    <count group_id="O2" value="272"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" spread="0.11"/>
                    <measurement group_id="O2" value="0.05" spread="0.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With First Moderate or Severe AECOPD</title>
        <description>Number of subjects with first occurrence of moderate or severe episode of AECOPD was reported, in order to compute time to first occurrence and derive the hazard rate using Cox's proportional hazard regression model.</description>
        <time_frame>From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)</time_frame>
        <population>The analysis was performed on the Modified Total Vaccinated cohort, which includes all vaccinated subjects with 2 documented study vaccine administrations with respect to the vaccine actually administered</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3277511A Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With First Moderate or Severe AECOPD</title>
          <description>Number of subjects with first occurrence of moderate or severe episode of AECOPD was reported, in order to compute time to first occurrence and derive the hazard rate using Cox's proportional hazard regression model.</description>
          <population>The analysis was performed on the Modified Total Vaccinated cohort, which includes all vaccinated subjects with 2 documented study vaccine administrations 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="278"/>
                <count group_id="O2" value="292"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="158"/>
                    <measurement group_id="O2" value="176"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Hazard rate for moderate or severe AECOPDs, one year follow-up starting 1 month post dose 2</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>The dependent variable is the time to first occurrence of the event. The reference is the Placebo.</non_inferiority_desc>
            <p_value>0.5751</p_value>
            <method>Regression, Cox</method>
            <method_desc>Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.94</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.758</ci_lower_limit>
            <ci_upper_limit>1.166</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With First AECOPD of Any Severity</title>
        <description>Number of subjects with first occurrence of any episode of AECOPD of any severity was reported, in order to compute time to first occurrence and derive the hazard rate using Cox's proportional hazard regression model.</description>
        <time_frame>From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)</time_frame>
        <population>The analysis was performed on the Modified Total Vaccinated cohort, which includes all vaccinated subjects with 2 documented study vaccine administrations with respect to the vaccine actually administered</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3277511A Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With First AECOPD of Any Severity</title>
          <description>Number of subjects with first occurrence of any episode of AECOPD of any severity was reported, in order to compute time to first occurrence and derive the hazard rate using Cox's proportional hazard regression model.</description>
          <population>The analysis was performed on the Modified Total Vaccinated cohort, which includes all vaccinated subjects with 2 documented study vaccine administrations 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="278"/>
                <count group_id="O2" value="292"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="168"/>
                    <measurement group_id="O2" value="188"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Hazard rate for any AECOPDs, one year follow-up starting 1 month post dose 2</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>The dependent variable is the time to first occurrence of the event. The reference is the Placebo.</non_inferiority_desc>
            <p_value>0.5194</p_value>
            <method>Regression, Cox</method>
            <method_desc>Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.934</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.758</ci_lower_limit>
            <ci_upper_limit>1.15</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With First AECOPD Classified by Severity</title>
        <description>Number of subjects with first occurrence of any episode of AECOPD classified by severity was reported, in order to compute time to first occurrence and derive the hazard rate using Cox's proportional hazard regression model.</description>
        <time_frame>From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)</time_frame>
        <population>The analysis was performed on the Modified Total Vaccinated cohort, which includes all vaccinated subjects with 2 documented study vaccine administrations with respect to the vaccine actually administered</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3277511A Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With First AECOPD Classified by Severity</title>
          <description>Number of subjects with first occurrence of any episode of AECOPD classified by severity was reported, in order to compute time to first occurrence and derive the hazard rate using Cox's proportional hazard regression model.</description>
          <population>The analysis was performed on the Modified Total Vaccinated cohort, which includes all vaccinated subjects with 2 documented study vaccine administrations 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="278"/>
                <count group_id="O2" value="292"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AFTER 1 MONTH POST DOSE 2, MILD</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AFTER 1 MONTH POST DOSE 2, MODERATE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="144"/>
                    <measurement group_id="O2" value="154"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AFTER 1 MONTH POST DOSE 2, SEVERE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Hazard rate for mild AECOPDs, one year follow-up starting 1 month post dose 2</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>The dependent variable is the time to first occurrence of the event. The reference is the Placebo.</non_inferiority_desc>
            <p_value>0.8581</p_value>
            <method>Regression, Cox</method>
            <method_desc>Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.616</ci_lower_limit>
            <ci_upper_limit>1.791</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Hazard rate for moderate AECOPDs, one year follow-up starting 1 month post dose 2</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>The dependent variable is the time to first occurrence of the event. The reference is the Placebo.</non_inferiority_desc>
            <p_value>0.9634</p_value>
            <method>Regression, Cox</method>
            <method_desc>Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.995</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.792</ci_lower_limit>
            <ci_upper_limit>1.249</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Hazard rate for severe AECOPDs, one year follow-up starting 1 month post dose 2</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>The dependent variable is the time to first occurrence of the event. The reference is the Placebo.</non_inferiority_desc>
            <p_value>0.1755</p_value>
            <method>Regression, Cox</method>
            <method_desc>Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.722</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.45</ci_lower_limit>
            <ci_upper_limit>1.157</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Days With Moderate and Severe AECOPDs</title>
        <description>The length of each AECOPD was tabulated and presented via descriptive statistics (mean, Standard Deviation) and expressed in Days.</description>
        <time_frame>From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)</time_frame>
        <population>The analysis was performed on the Modified Total Vaccinated cohort, which includes all vaccinated subjects with 2 documented study vaccine administrations with respect to the vaccine actually administered.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3277511A Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Days With Moderate and Severe AECOPDs</title>
          <description>The length of each AECOPD was tabulated and presented via descriptive statistics (mean, Standard Deviation) and expressed in Days.</description>
          <population>The analysis was performed on the Modified Total Vaccinated cohort, which includes all vaccinated subjects with 2 documented study vaccine administrations 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="279"/>
                <count group_id="O2" value="292"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.6" spread="14.29"/>
                    <measurement group_id="O2" value="15.6" spread="13.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Days With AECOPDs of Any Severity</title>
        <description>The length of each AECOPDs was tabulated and presented via descriptive statistics (mean, Standard Deviation).</description>
        <time_frame>From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)</time_frame>
        <population>The analysis was performed on the Modified Total Vaccinated cohort, which includes all vaccinated subjects with 2 documented study vaccine administrations with respect to the vaccine actually administered.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3277511A Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Days With AECOPDs of Any Severity</title>
          <description>The length of each AECOPDs was tabulated and presented via descriptive statistics (mean, Standard Deviation).</description>
          <population>The analysis was performed on the Modified Total Vaccinated cohort, which includes all vaccinated subjects with 2 documented study vaccine administrations 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="279"/>
                <count group_id="O2" value="292"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.9" spread="13.79"/>
                    <measurement group_id="O2" value="15.3" spread="13.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Days With AECOPDs Classified by Severity</title>
        <description>The length of each AECOPDs by severity was tabulated and presented via descriptive statistics (mean, Standard Deviation).</description>
        <time_frame>From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)</time_frame>
        <population>The analysis was performed on the Modified Total Vaccinated cohort, which includes all vaccinated subjects with 2 documented study vaccine administrations with respect to the vaccine actually administered.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3277511A Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Days With AECOPDs Classified by Severity</title>
          <description>The length of each AECOPDs by severity was tabulated and presented via descriptive statistics (mean, Standard Deviation).</description>
          <population>The analysis was performed on the Modified Total Vaccinated cohort, which includes all vaccinated subjects with 2 documented study vaccine administrations 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="279"/>
                <count group_id="O2" value="292"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>MILD, AFTER 1 MONTH POST DOSE 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.9" spread="3.56"/>
                    <measurement group_id="O2" value="12.3" spread="9.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MODERATE, AFTER 1 MONTH POST DOSE 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.1" spread="13.90"/>
                    <measurement group_id="O2" value="14.5" spread="10.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SEVERE, AFTER 1 MONTH POST DOSE 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.4" spread="16.78"/>
                    <measurement group_id="O2" value="21.2" spread="23.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of Non-Typeable Haemophilus Influenzae (NTHi)-Associated and/ or Moraxella Catarrhalis (Mcat)-Associated Moderate and Severe AECOPD</title>
        <description>The rates of AECOPD were expressed per year and calculated as the total number of events over the follow-up exposure time. The CIs of the rate was computed using a model which accounts for repeated events. Respiratory pathogens NTHi and Mcat was determined by Polymerase chain reaction (PCR) analysis in sputum samples.</description>
        <time_frame>From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)</time_frame>
        <population>The analysis was performed on the Modified Total Vaccinated cohort, which includes all vaccinated subjects with 2 documented study vaccine administrations with respect to the vaccine actually administered.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3277511A Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Non-Typeable Haemophilus Influenzae (NTHi)-Associated and/ or Moraxella Catarrhalis (Mcat)-Associated Moderate and Severe AECOPD</title>
          <description>The rates of AECOPD were expressed per year and calculated as the total number of events over the follow-up exposure time. The CIs of the rate was computed using a model which accounts for repeated events. Respiratory pathogens NTHi and Mcat was determined by Polymerase chain reaction (PCR) analysis in sputum samples.</description>
          <population>The analysis was performed on the Modified Total Vaccinated cohort, which includes all vaccinated subjects with 2 documented study vaccine administrations with respect to the vaccine actually administered.</population>
          <units>exacerbations per person-year</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="278"/>
                <count group_id="O2" value="292"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.32" lower_limit="0.25" upper_limit="0.42"/>
                    <measurement group_id="O2" value="0.32" lower_limit="0.24" upper_limit="0.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of NTHi-associated and/ or Mcat-associated AECOPD of Any Severity</title>
        <description>The rates of AECOPD of any severity were expressed per year and calculated as the total number of events over the follow-up exposure time. The CIs of the rate was computed using a model which accounts for repeated events. Respiratory pathogens NTHi and Mcat was determined by polymerase chain reaction (PCR) analysis in sputum samples.</description>
        <time_frame>From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)</time_frame>
        <population>The analysis was performed on the Modified Total Vaccinated cohort, which includes all vaccinated subjects with 2 documented study vaccine administrations with respect to the vaccine actually administered.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3277511A Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of NTHi-associated and/ or Mcat-associated AECOPD of Any Severity</title>
          <description>The rates of AECOPD of any severity were expressed per year and calculated as the total number of events over the follow-up exposure time. The CIs of the rate was computed using a model which accounts for repeated events. Respiratory pathogens NTHi and Mcat was determined by polymerase chain reaction (PCR) analysis in sputum samples.</description>
          <population>The analysis was performed on the Modified Total Vaccinated cohort, which includes all vaccinated subjects with 2 documented study vaccine administrations with respect to the vaccine actually administered.</population>
          <units>exacerbations per person- year</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="278"/>
                <count group_id="O2" value="292"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.39" lower_limit="0.30" upper_limit="0.50"/>
                    <measurement group_id="O2" value="0.35" lower_limit="0.27" upper_limit="0.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Exacerbation Rate of Any NTHi-associated and/ or Mcat-associated AECOPD Cases, Classified by Severity</title>
        <description>The exacerbation rate of any AECOPD by severity is the average number of exacerbations for each subject: it is calculated proportionally to the follow-up time per subject, and then scaled to the period considered. Mean and standard deviation of the exacerbation rate are given for the period considered. Respiratory pathogens NTHi and Mcat was determined PCR analysis in sputum samples</description>
        <time_frame>From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)</time_frame>
        <population>The analysis was performed on the Modified Total Vaccinated cohort, which includes all vaccinated subjects with 2 documented study vaccine administrations with respect to the vaccine actually administered.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3277511A Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.</description>
          </group>
        </group_list>
        <measure>
          <title>Exacerbation Rate of Any NTHi-associated and/ or Mcat-associated AECOPD Cases, Classified by Severity</title>
          <description>The exacerbation rate of any AECOPD by severity is the average number of exacerbations for each subject: it is calculated proportionally to the follow-up time per subject, and then scaled to the period considered. Mean and standard deviation of the exacerbation rate are given for the period considered. Respiratory pathogens NTHi and Mcat was determined PCR analysis in sputum samples</description>
          <population>The analysis was performed on the Modified Total Vaccinated cohort, which includes all vaccinated subjects with 2 documented study vaccine administrations with respect to the vaccine actually administered.</population>
          <units>exacerbations per person</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="278"/>
                <count group_id="O2" value="292"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>MILD, AFTER 1 MONTH POST DOSE 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.06" spread="0.28"/>
                    <measurement group_id="O2" value="0.03" spread="0.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MODERATE, AFTER 1 MONTH POST DOSE 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="0.67"/>
                    <measurement group_id="O2" value="0.31" spread="0.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SEVERE, AFTER 1 MONTH POST DOSE 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.02" spread="0.18"/>
                    <measurement group_id="O2" value="0.01" spread="0.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With First Moderate or Severe NTHi-associated and/or Mcat-associated AECOPD</title>
        <description>Number of subjects with first occurrence of moderate or severe NTHI-associated and/or Mcat-associated AECOPD was reported,in order to compute time to first occurrence and derive the hazard rate using Cox's proportional hazard regression model. Respiratory pathogens NTHi and Mcat was determined PCR analysis in sputum samples.</description>
        <time_frame>From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)</time_frame>
        <population>The analysis was performed on the Modified Total Vaccinated cohort, which includes all vaccinated subjects with 2 documented study vaccine administrations with respect to the vaccine actually administered</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3277511A Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With First Moderate or Severe NTHi-associated and/or Mcat-associated AECOPD</title>
          <description>Number of subjects with first occurrence of moderate or severe NTHI-associated and/or Mcat-associated AECOPD was reported,in order to compute time to first occurrence and derive the hazard rate using Cox's proportional hazard regression model. Respiratory pathogens NTHi and Mcat was determined PCR analysis in sputum samples.</description>
          <population>The analysis was performed on the Modified Total Vaccinated cohort, which includes all vaccinated subjects with 2 documented study vaccine administrations 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="278"/>
                <count group_id="O2" value="292"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62"/>
                    <measurement group_id="O2" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Hazard rate for moderate or severe NTHi-associated and/or Mcat-associated AECOPDs, one year follow-up starting 1 month post dose 2</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>The dependent variable is the time to first occurrence of the event. The reference is the Placebo.</non_inferiority_desc>
            <p_value>0.9463</p_value>
            <method>Regression, Cox</method>
            <method_desc>Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.038</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.73</ci_lower_limit>
            <ci_upper_limit>1.477</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With First NTHi-associated and/or Mcat-associated AECOPD of Any Severity</title>
        <description>Number of subjects with first occurrence of NTHI-associated and/or Mcat-associated AECOPD of any severity was reported,in order to compute time to first occurrence and derive the hazard rate using Cox's proportional hazard regression model. Respiratory pathogens NTHi and Mcat was determined PCR analysis in sputum samples.</description>
        <time_frame>From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)</time_frame>
        <population>The analysis was performed on the Modified Total Vaccinated cohort, which includes all vaccinated subjects with 2 documented study vaccine administrations with respect to the vaccine actually administered</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3277511A Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With First NTHi-associated and/or Mcat-associated AECOPD of Any Severity</title>
          <description>Number of subjects with first occurrence of NTHI-associated and/or Mcat-associated AECOPD of any severity was reported,in order to compute time to first occurrence and derive the hazard rate using Cox's proportional hazard regression model. Respiratory pathogens NTHi and Mcat was determined PCR analysis in sputum samples.</description>
          <population>The analysis was performed on the Modified Total Vaccinated cohort, which includes all vaccinated subjects with 2 documented study vaccine administrations 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="278"/>
                <count group_id="O2" value="292"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70"/>
                    <measurement group_id="O2" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Hazard rate for any NTHi-associated and/or Mcat-associated AECOPDs, one year follow-up starting 1 month post dose 2</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>The dependent variable is the time to first occurrence of the event. The reference is the Placebo.</non_inferiority_desc>
            <p_value>0.6042</p_value>
            <method>Regression, Cox</method>
            <method_desc>Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.093</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.782</ci_lower_limit>
            <ci_upper_limit>1.528</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With First NTHi-associated and/or Mcat-associated AECOPD, Classified by Severity</title>
        <description>Number of subjects with first occurrence of NTHI-associated and/or Mcat-associated AECOPD classified by severity was reported, in order to compute time to first occurrence and derive the hazard rate using Cox's proportional hazard regression model. Respiratory pathogens NTHi and Mcat was determined PCR analysis in sputum samples.</description>
        <time_frame>From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)</time_frame>
        <population>The analysis was performed on the Modified Total Vaccinated cohort, which includes all vaccinated subjects with 2 documented study vaccine administrations with respect to the vaccine actually administered</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3277511A Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With First NTHi-associated and/or Mcat-associated AECOPD, Classified by Severity</title>
          <description>Number of subjects with first occurrence of NTHI-associated and/or Mcat-associated AECOPD classified by severity was reported, in order to compute time to first occurrence and derive the hazard rate using Cox's proportional hazard regression model. Respiratory pathogens NTHi and Mcat was determined PCR analysis in sputum samples.</description>
          <population>The analysis was performed on the Modified Total Vaccinated cohort, which includes all vaccinated subjects with 2 documented study vaccine administrations 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="278"/>
                <count group_id="O2" value="292"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AFTER 1 MONTH POST DOSE 2, MILD</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AFTER 1 MONTH POST DOSE 2, MODERATE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58"/>
                    <measurement group_id="O2" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AFTER 1 MONTH POST DOSE 2, SEVERE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Hazard rate for mild NTHi-associated and/or Mcat-associated AECOPDs, one year follow-up starting 1 month post dose 2</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>The dependent variable is the time to first occurrence of the event. The reference is the Placebo.</non_inferiority_desc>
            <p_value>0.0777</p_value>
            <method>Regression, Cox</method>
            <method_desc>Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>2.243</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.914</ci_lower_limit>
            <ci_upper_limit>5.504</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Hazard rate for moderate NTHi-associated and/or Mcat-associated AECOPDs, one year follow-up starting 1 month post dose 2</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>The dependent variable is the time to first occurrence of the event. The reference is the Placebo.</non_inferiority_desc>
            <p_value>0.9121</p_value>
            <method>Regression, Cox</method>
            <method_desc>Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.021</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.71</ci_lower_limit>
            <ci_upper_limit>1.467</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Hazard rate for severe NTHi-associated and/or Mcat-associated AECOPDs, one year follow-up starting 1 month post dose 2</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>The dependent variable is the time to first occurrence of the event. The reference is the Placebo.</non_inferiority_desc>
            <p_value>0.8737</p_value>
            <method>Regression, Cox</method>
            <method_desc>Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.12</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.278</ci_lower_limit>
            <ci_upper_limit>4.502</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Days With Moderate and Severe NTHi-associated and Mcat-associated AECOPD</title>
        <description>The length of each NTHi associated and/or Mcat associated AECOPDs was tabulated and presented via descriptive statistics (mean, Standard Deviation).</description>
        <time_frame>From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)</time_frame>
        <population>The analysis was performed on the Modified Total Vaccinated cohort, which includes all vaccinated subjects with 2 documented study vaccine administrations with respect to the vaccine actually administered.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3277511A Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Days With Moderate and Severe NTHi-associated and Mcat-associated AECOPD</title>
          <description>The length of each NTHi associated and/or Mcat associated AECOPDs was tabulated and presented via descriptive statistics (mean, Standard Deviation).</description>
          <population>The analysis was performed on the Modified Total Vaccinated cohort, which includes all vaccinated subjects with 2 documented study vaccine administrations 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="279"/>
                <count group_id="O2" value="292"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14" spread="10.43"/>
                    <measurement group_id="O2" value="12.3" spread="5.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Days With NTHi-associated and/or Mcat-associated AECOPDs of Any Severity</title>
        <description>The length of each NTHi associated and/or Mcat associated AECOPDs was tabulated and presented via descriptive statistics (mean, Standard Deviation).</description>
        <time_frame>From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)</time_frame>
        <population>The analysis was performed on the Modified Total Vaccinated cohort, which includes all vaccinated subjects with 2 documented study vaccine administrations with respect to the vaccine actually administered.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3277511A Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Days With NTHi-associated and/or Mcat-associated AECOPDs of Any Severity</title>
          <description>The length of each NTHi associated and/or Mcat associated AECOPDs was tabulated and presented via descriptive statistics (mean, Standard Deviation).</description>
          <population>The analysis was performed on the Modified Total Vaccinated cohort, which includes all vaccinated subjects with 2 documented study vaccine administrations 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="279"/>
                <count group_id="O2" value="292"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.3" spread="9.76"/>
                    <measurement group_id="O2" value="12.1" spread="5.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Days With NTHi-associated and/or Mcat-associated AECOPD, Classified by Severity</title>
        <description>The length of each NTHi associated and/or Mcat associated AECOPDs was tabulated and presented via descriptive statistics (mean, Standard Deviation).</description>
        <time_frame>From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)</time_frame>
        <population>The analysis was performed on the Modified Total Vaccinated cohort, which includes all vaccinated subjects with 2 documented study vaccine administrations with respect to the vaccine actually administered.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3277511A Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Days With NTHi-associated and/or Mcat-associated AECOPD, Classified by Severity</title>
          <description>The length of each NTHi associated and/or Mcat associated AECOPDs was tabulated and presented via descriptive statistics (mean, Standard Deviation).</description>
          <population>The analysis was performed on the Modified Total Vaccinated cohort, which includes all vaccinated subjects with 2 documented study vaccine administrations 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="279"/>
                <count group_id="O2" value="292"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AFTER 1 MONTH POST DOSE 2, MILD</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.5" spread="3.54"/>
                    <measurement group_id="O2" value="9.9" spread="6.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AFTER 1 MONTH POST DOSE 2, MODERATE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.8" spread="10.41"/>
                    <measurement group_id="O2" value="12.5" spread="5.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AFTER 1 MONTH POST DOSE 2, SEVERE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.3" spread="11.02"/>
                    <measurement group_id="O2" value="7.5" spread="1.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anti-PD Antibody Concentrations as Measured by the Enzyme-Linked Immunosorbent Assay (ELISA)</title>
        <description>Anti-Protein D (PD) antibody concentrations as determined by ELISA, and expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EU/mL). For anti-PD antibodies, the cut-off of the assay is 153 ELISA Units per millilitre (EU/mL.)</description>
        <time_frame>At Day 1, Day 31, Day 61, Day 91, Day 271 and at Day 451</time_frame>
        <population>The analysis was performed on the Per-Protocol immuno set for analysis of immunogenicity cohort which includes all vaccinated subjects who complied with the vaccination schedule and who have immunogenicity data for the specified timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3277511A Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.</description>
          </group>
        </group_list>
        <measure>
          <title>Anti-PD Antibody Concentrations as Measured by the Enzyme-Linked Immunosorbent Assay (ELISA)</title>
          <description>Anti-Protein D (PD) antibody concentrations as determined by ELISA, and expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EU/mL). For anti-PD antibodies, the cut-off of the assay is 153 ELISA Units per millilitre (EU/mL.)</description>
          <population>The analysis was performed on the Per-Protocol immuno set for analysis of immunogenicity cohort which includes all vaccinated subjects who complied with the vaccination schedule and who have immunogenicity data for the specified timepoints.</population>
          <units>EU/mL.</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="247"/>
                <count group_id="O2" value="256"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="247"/>
                    <count group_id="O2" value="256"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="103.7" lower_limit="93.8" upper_limit="114.7"/>
                    <measurement group_id="O2" value="95.4" lower_limit="86.3" upper_limit="105.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 31</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="232"/>
                    <count group_id="O2" value="243"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1048.1" lower_limit="910.2" upper_limit="1206.8"/>
                    <measurement group_id="O2" value="98.2" lower_limit="85.3" upper_limit="113.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 61</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="239"/>
                    <count group_id="O2" value="253"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="654.6" lower_limit="572.3" upper_limit="748.9"/>
                    <measurement group_id="O2" value="95.5" lower_limit="83.6" upper_limit="109.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 91</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="208"/>
                    <count group_id="O2" value="211"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1521.4" lower_limit="1357.6" upper_limit="1704.9"/>
                    <measurement group_id="O2" value="90.3" lower_limit="80.6" upper_limit="101.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 271</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="210"/>
                    <count group_id="O2" value="223"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="546" lower_limit="480.3" upper_limit="620.8"/>
                    <measurement group_id="O2" value="94.8" lower_limit="83.6" upper_limit="107.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 451</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="221"/>
                    <count group_id="O2" value="216"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="444.1" lower_limit="390.2" upper_limit="505.4"/>
                    <measurement group_id="O2" value="97.9" lower_limit="85.9" upper_limit="111.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anti-PE Antibody Concentrations as Measured by ELISA</title>
        <description>Anti-Protein E (PE) antibody concentrations as determined by ELISA and expressed as GMCs in EU/mL For Anti-PE antibodies, the cut-off of the assay is 16 EU/mL.</description>
        <time_frame>At Day 1, Day 31, Day 61, Day 91, Day 271 and at Day 451</time_frame>
        <population>The analysis was performed on the Per-Protocol immuno set for analysis of immunogenicity cohort which includes all vaccinated subjects who complied with the vaccination schedule and who have immunogenicity data for the specified timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3277511A Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.</description>
          </group>
        </group_list>
        <measure>
          <title>Anti-PE Antibody Concentrations as Measured by ELISA</title>
          <description>Anti-Protein E (PE) antibody concentrations as determined by ELISA and expressed as GMCs in EU/mL For Anti-PE antibodies, the cut-off of the assay is 16 EU/mL.</description>
          <population>The analysis was performed on the Per-Protocol immuno set for analysis of immunogenicity cohort which includes all vaccinated subjects who complied with the vaccination schedule and who have immunogenicity data for the specified timepoints.</population>
          <units>EU/mL.</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="246"/>
                <count group_id="O2" value="256"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="246"/>
                    <count group_id="O2" value="256"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.9" lower_limit="17.6" upper_limit="24.8"/>
                    <measurement group_id="O2" value="21.6" lower_limit="18.2" upper_limit="25.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 31</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="232"/>
                    <count group_id="O2" value="244"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1108.1" lower_limit="921.5" upper_limit="1332.5"/>
                    <measurement group_id="O2" value="20.7" lower_limit="17.2" upper_limit="24.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 61</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="239"/>
                    <count group_id="O2" value="251"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="872.8" lower_limit="726.6" upper_limit="1048.3"/>
                    <measurement group_id="O2" value="20.5" lower_limit="17.1" upper_limit="24.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 91</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="208"/>
                    <count group_id="O2" value="211"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6020" lower_limit="5181.2" upper_limit="6994.7"/>
                    <measurement group_id="O2" value="20.1" lower_limit="17.3" upper_limit="23.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 271</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="210"/>
                    <count group_id="O2" value="223"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1254.9" lower_limit="1069.5" upper_limit="1472.5"/>
                    <measurement group_id="O2" value="19.3" lower_limit="16.5" upper_limit="22.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 451</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="221"/>
                    <count group_id="O2" value="215"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="835.2" lower_limit="715.0" upper_limit="975.6"/>
                    <measurement group_id="O2" value="19.7" lower_limit="16.8" upper_limit="23.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anti-PilA Antibody Concentrations as Measured by ELISA</title>
        <description>Anti-Type IV pilus assembly protein (PilA) antibody concentrations as determined by ELISA, and expressed as GMCs in EU/mL. For Anti-PilA antibodies, the cut-off of the assay is 8 EU/mL.</description>
        <time_frame>At Day 1, Day 31, Day 61, Day 91, Day 271 and at Day 451</time_frame>
        <population>The analysis was performed on the Per-Protocol immuno set for analysis of immunogenicity cohort which includes all vaccinated subjects who complied with the vaccination schedule and who have immunogenicity data for the specified timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3277511A Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.</description>
          </group>
        </group_list>
        <measure>
          <title>Anti-PilA Antibody Concentrations as Measured by ELISA</title>
          <description>Anti-Type IV pilus assembly protein (PilA) antibody concentrations as determined by ELISA, and expressed as GMCs in EU/mL. For Anti-PilA antibodies, the cut-off of the assay is 8 EU/mL.</description>
          <population>The analysis was performed on the Per-Protocol immuno set for analysis of immunogenicity cohort which includes all vaccinated subjects who complied with the vaccination schedule and who have immunogenicity data for the specified timepoints.</population>
          <units>EU/mL.</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="247"/>
                <count group_id="O2" value="256"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="247"/>
                    <count group_id="O2" value="256"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.3" lower_limit="6.9" upper_limit="9.8"/>
                    <measurement group_id="O2" value="8.5" lower_limit="7.1" upper_limit="10.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 31</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="231"/>
                    <count group_id="O2" value="243"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="153" lower_limit="124.2" upper_limit="188.6"/>
                    <measurement group_id="O2" value="9.2" lower_limit="7.5" upper_limit="11.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 61</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="238"/>
                    <count group_id="O2" value="251"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="134.2" lower_limit="109.7" upper_limit="164.2"/>
                    <measurement group_id="O2" value="8.8" lower_limit="7.2" upper_limit="10.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 91</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="208"/>
                    <count group_id="O2" value="211"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="913.5" lower_limit="770.5" upper_limit="1082.9"/>
                    <measurement group_id="O2" value="8.9" lower_limit="7.5" upper_limit="10.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 271</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="210"/>
                    <count group_id="O2" value="223"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="189.6" lower_limit="159.2" upper_limit="225.7"/>
                    <measurement group_id="O2" value="8" lower_limit="6.8" upper_limit="9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 451</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="221"/>
                    <count group_id="O2" value="216"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="126.5" lower_limit="106.1" upper_limit="150.8"/>
                    <measurement group_id="O2" value="8.3" lower_limit="6.9" upper_limit="9.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anti-UspA2 Antibody Concentrations as Measured by ELISA</title>
        <description>Anti-ubiquitous surface protein A2 of Moraxella catarrhalis (UspA2) aantibody concentrations as determined by ELISA, and expressed as GMCs in EU/mL. For Anti-UspA2 antibodies, the cut-off of the assay is 28 EU/mL.</description>
        <time_frame>At Day 1, Day 31, Day 61, Day 91, Day 271 and at Day 451</time_frame>
        <population>The analysis was performed on the Per-Protocol immuno set for analysis of immunogenicity cohort which includes all vaccinated subjects who complied with the vaccination schedule and who have immunogenicity data for the specified timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3277511A Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.</description>
          </group>
        </group_list>
        <measure>
          <title>Anti-UspA2 Antibody Concentrations as Measured by ELISA</title>
          <description>Anti-ubiquitous surface protein A2 of Moraxella catarrhalis (UspA2) aantibody concentrations as determined by ELISA, and expressed as GMCs in EU/mL. For Anti-UspA2 antibodies, the cut-off of the assay is 28 EU/mL.</description>
          <population>The analysis was performed on the Per-Protocol immuno set for analysis of immunogenicity cohort which includes all vaccinated subjects who complied with the vaccination schedule and who have immunogenicity data for the specified timepoints.</population>
          <units>EU/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="246"/>
                <count group_id="O2" value="255"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="246"/>
                    <count group_id="O2" value="255"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="540.3" lower_limit="452.6" upper_limit="645.0"/>
                    <measurement group_id="O2" value="604.7" lower_limit="507.2" upper_limit="721.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 31</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="232"/>
                    <count group_id="O2" value="242"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1092.1" lower_limit="997.5" upper_limit="1195.5"/>
                    <measurement group_id="O2" value="485.2" lower_limit="442.9" upper_limit="531.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 61</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="238"/>
                    <count group_id="O2" value="251"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="848.7" lower_limit="781.5" upper_limit="921.5"/>
                    <measurement group_id="O2" value="473.5" lower_limit="436.2" upper_limit="513.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 91</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="208"/>
                    <count group_id="O2" value="211"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1223.7" lower_limit="1110.8" upper_limit="1348.0"/>
                    <measurement group_id="O2" value="446" lower_limit="404.5" upper_limit="491.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 271</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="210"/>
                    <count group_id="O2" value="222"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="645.1" lower_limit="582.1" upper_limit="714.8"/>
                    <measurement group_id="O2" value="445.4" lower_limit="402.7" upper_limit="492.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 451</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="221"/>
                    <count group_id="O2" value="215"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="575.9" lower_limit="512.9" upper_limit="646.7"/>
                    <measurement group_id="O2" value="468.5" lower_limit="416.5" upper_limit="527.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of PD Specific Cluster of Differentiation (CD)4+ T-cells Expressing at Least 2 Markers Among CD40L, IL2, TNF-Alpha, IFN-Gamma, IL-13 and IL-17 Using Background Reduced Frequency Data</title>
        <description>The ICS staining assay was used to assess cell-mediated immunogenicity (CMI) responses. After Peripheral blood mononuclear cell (PBMC) stimulation with the relevant antigen, the frequency of PD specific CD4+ T-cells expressing selected combination of cytokines such as interleukine-2, 13, 17 (IL-2, IL-13, IL-17), interferon-gamma (IFN-γ), tumour necrosis factor-alpha (TNF-α) and cluster of differentiation 40 ligand (CD40L) are evaluated by flow cytometry and expressed as mean and standard deviation.</description>
        <time_frame>At Day 1, Day 91, Day 271 and at Day 451</time_frame>
        <population>The analysis was performed on the Per-Protocol CMI set for analysis of immunogenicity cohort which includes all vaccinated subjects who were complied with the vaccination schedule and who have CMI data for the specified timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3277511A Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of PD Specific Cluster of Differentiation (CD)4+ T-cells Expressing at Least 2 Markers Among CD40L, IL2, TNF-Alpha, IFN-Gamma, IL-13 and IL-17 Using Background Reduced Frequency Data</title>
          <description>The ICS staining assay was used to assess cell-mediated immunogenicity (CMI) responses. After Peripheral blood mononuclear cell (PBMC) stimulation with the relevant antigen, the frequency of PD specific CD4+ T-cells expressing selected combination of cytokines such as interleukine-2, 13, 17 (IL-2, IL-13, IL-17), interferon-gamma (IFN-γ), tumour necrosis factor-alpha (TNF-α) and cluster of differentiation 40 ligand (CD40L) are evaluated by flow cytometry and expressed as mean and standard deviation.</description>
          <population>The analysis was performed on the Per-Protocol CMI set for analysis of immunogenicity cohort which includes all vaccinated subjects who were complied with the vaccination schedule and who have CMI data for the specified timepoints.</population>
          <units>T cells/million cells</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.6" spread="125.7"/>
                    <measurement group_id="O2" value="59.7" spread="118.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 91</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="890.2" spread="988.8"/>
                    <measurement group_id="O2" value="55.8" spread="88.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 271</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="364.6" spread="363.9"/>
                    <measurement group_id="O2" value="51.8" spread="90.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 451</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="267" spread="282.6"/>
                    <measurement group_id="O2" value="46.7" spread="101.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of PE Specific (CD)4+ T-cells Expressing at Least 2 Markers Among CD40L, IL2, TNF-Alpha, IFN-Gamma, IL-13 and IL-17 Using Background Reduced Frequency Data</title>
        <description>The ICS staining assay was used to assess CMI responses. After PBMC stimulation with the relevant antigen, the frequency of PE specific CD4+ T-cells expressing selected combination of cytokines such as (IL-2, IL-13, IL-17), IFN-γ, TNF-α and CD40L are evaluated by flow cytometry and expressed as mean and standard deviation.</description>
        <time_frame>At Day 1, Day 91, Day 271 and at Day 451</time_frame>
        <population>The analysis was performed on the Per-Protocol CMI set for analysis of immunogenicity cohort which includes all vaccinated subjects who were complied with the vaccination schedule and who have CMI data for the specified timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3277511A Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of PE Specific (CD)4+ T-cells Expressing at Least 2 Markers Among CD40L, IL2, TNF-Alpha, IFN-Gamma, IL-13 and IL-17 Using Background Reduced Frequency Data</title>
          <description>The ICS staining assay was used to assess CMI responses. After PBMC stimulation with the relevant antigen, the frequency of PE specific CD4+ T-cells expressing selected combination of cytokines such as (IL-2, IL-13, IL-17), IFN-γ, TNF-α and CD40L are evaluated by flow cytometry and expressed as mean and standard deviation.</description>
          <population>The analysis was performed on the Per-Protocol CMI set for analysis of immunogenicity cohort which includes all vaccinated subjects who were complied with the vaccination schedule and who have CMI data for the specified timepoints.</population>
          <units>T cells/million cells</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.1" spread="211.4"/>
                    <measurement group_id="O2" value="92.9" spread="266.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 91</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="797" spread="1082.9"/>
                    <measurement group_id="O2" value="76.2" spread="195.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 271</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="384.8" spread="539.9"/>
                    <measurement group_id="O2" value="61.4" spread="207.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 451</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="335.7" spread="493.7"/>
                    <measurement group_id="O2" value="81.2" spread="258.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of PilA Specific CD4+ T-cells Expressing at Least 2 Markers Among CD40L, IL2, TNF-Alpha, IFN-Gamma, IL-13 and IL-17 Using Background Reduced Frequency Data</title>
        <description>The ICS staining assay was used to assess CMI responses. After PBMC stimulation with the relevant antigen, the frequency of PilA specific CD4+ T-cells expressing selected combination of cytokines such as IL-2, IL-13, IL-17, IFN-γ, TNF-α and CD40L are evaluated by flow cytometry and expressed as mean and standard deviation.</description>
        <time_frame>At Day 1, Day 91, Day 271 and at Day 451</time_frame>
        <population>The analysis was performed on the Per-Protocol CMI set for analysis of immunogenicity cohort which includes all vaccinated subjects who were complied with the vaccination schedule and who have CMI data for the specified timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3277511A Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of PilA Specific CD4+ T-cells Expressing at Least 2 Markers Among CD40L, IL2, TNF-Alpha, IFN-Gamma, IL-13 and IL-17 Using Background Reduced Frequency Data</title>
          <description>The ICS staining assay was used to assess CMI responses. After PBMC stimulation with the relevant antigen, the frequency of PilA specific CD4+ T-cells expressing selected combination of cytokines such as IL-2, IL-13, IL-17, IFN-γ, TNF-α and CD40L are evaluated by flow cytometry and expressed as mean and standard deviation.</description>
          <population>The analysis was performed on the Per-Protocol CMI set for analysis of immunogenicity cohort which includes all vaccinated subjects who were complied with the vaccination schedule and who have CMI data for the specified timepoints.</population>
          <units>T cells/million cells</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.2" spread="45.4"/>
                    <measurement group_id="O2" value="53.3" spread="95.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 91</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="305.8" spread="321.7"/>
                    <measurement group_id="O2" value="44.6" spread="114.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 271</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="137.3" spread="163.2"/>
                    <measurement group_id="O2" value="42.1" spread="78.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 451</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="141" spread="147.1"/>
                    <measurement group_id="O2" value="42.4" spread="95.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of UspA2 Specific CD4 + T-cells Expressing at Least 2 Markers Among CD40L, IL2, TNF-Alpha, IFN-Gamma, IL-13 and IL-17 Using Background Reduced Frequency Data</title>
        <description>The ICS staining assay was used to assess CMI responses. After PBMC stimulation with the relevant antigen, the frequency of UspA2 specific CD4+ T-cells expressing selected combination of cytokines such as IL-2, IL-13, IL-17, IFN-γ, TNF-α and CD40L are evaluated by flow cytometry and expressed as mean and standard deviation.</description>
        <time_frame>At Day 1, Day 91, Day 271 and at Day 451</time_frame>
        <population>The analysis was performed on the Per-Protocol CMI set for analysis of immunogenicity cohort which includes all vaccinated subjects who were complied with the vaccination schedule and who have CMI data for the specified timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3277511A Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of UspA2 Specific CD4 + T-cells Expressing at Least 2 Markers Among CD40L, IL2, TNF-Alpha, IFN-Gamma, IL-13 and IL-17 Using Background Reduced Frequency Data</title>
          <description>The ICS staining assay was used to assess CMI responses. After PBMC stimulation with the relevant antigen, the frequency of UspA2 specific CD4+ T-cells expressing selected combination of cytokines such as IL-2, IL-13, IL-17, IFN-γ, TNF-α and CD40L are evaluated by flow cytometry and expressed as mean and standard deviation.</description>
          <population>The analysis was performed on the Per-Protocol CMI set for analysis of immunogenicity cohort which includes all vaccinated subjects who were complied with the vaccination schedule and who have CMI data for the specified timepoints.</population>
          <units>T cells/million cells</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.1" spread="177.1"/>
                    <measurement group_id="O2" value="47.2" spread="85.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 91</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="646.3" spread="545.2"/>
                    <measurement group_id="O2" value="70.3" spread="94.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 271</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="330.5" spread="278.5"/>
                    <measurement group_id="O2" value="60.8" spread="80.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 451</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="35"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="331.3" spread="310.4"/>
                    <measurement group_id="O2" value="61.5" spread="89.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Solicited AEs reported during the 7-day follow-up period and Unsolicited AEs reported during the 30-day follow-up period after any vaccination. SAEs reported from first vaccination (Day 1) up to Study end (at Day 451 - an average of 15 months).</time_frame>
      <group_list>
        <group group_id="E1">
          <title>GSK3277511A Group</title>
          <description>Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2), administered at Day 1 and Day 61</description>
        </group>
        <group group_id="E2">
          <title>Control Group</title>
          <description>Healthy males and females, 40 to 80 years of age, who received two doses of placebo, administered at Day 1 and Day 61.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="89" subjects_at_risk="304"/>
                <counts group_id="E2" subjects_affected="99" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute left ventricular failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="304"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Cardiomyopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Coronary artery insufficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Pericardial effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Sinus node dysfunction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Stress cardiomyopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Trifascicular block</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Ventricular tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Dyschezia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Enterovesical fistula</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Ileus paralytic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Intestinal pseudo-obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Lower gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Retroperitoneal haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Condition aggravated</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Drug withdrawal syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Cirrhosis alcoholic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abdominal abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>CNS ventriculitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Enterococcal infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Enterocolitis viral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Graft infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Infective exacerbation of chronic obstructive airways disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="304"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Metapneumovirus infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="304"/>
                <counts group_id="E2" events="17" subjects_affected="15" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Pneumonia pneumococcal</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Pneumonia pseudomonal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Pneumonia staphylococcal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Respiratory syncytial virus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Tracheobronchitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Wound abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Abdominal wound dehiscence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Alcohol poisoning</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Anastomotic complication</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Drain site complication</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Exposure to toxic agent</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Femoral neck fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Head injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Intentional overdose</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Ligament rupture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Musculoskeletal procedural complication</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Post procedural haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Procedural pneumothorax</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Radius fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Thoracic vertebral fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Toxicity to various agents</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Oxygen saturation decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Acidosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Diabetic metabolic decompensation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Cervical spinal stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Intervertebral disc degeneration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Tenosynovitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Adenocarcinoma gastric</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Adenocarcinoma of colon</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Colon cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Hepatic cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Hypopharyngeal cancer stage IV</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Laryngeal cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Leukaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Lung neoplasm malignant</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Metastatic gastric cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Ovarian cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Pancreatic carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Penile cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of lung</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of skin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Transitional cell carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrospinal fluid leakage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Guillain-Barre syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Haemorrhage intracranial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Hemiplegic migraine</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Lumbar radiculopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Ruptured cerebral aneurysm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Subarachnoid haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device loosening</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Alcohol withdrawal syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Urinary incontinence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Breast mass</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Scrotal inflammation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute pulmonary oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Acute respiratory distress syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="304"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Atelectasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Bronchiectasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Bronchitis chronic</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="55" subjects_affected="41" subjects_at_risk="304"/>
                <counts group_id="E2" events="83" subjects_affected="53" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Pulmonary arterial hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Pulmonary mass</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="304"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic aneurysm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Femoral artery aneurysm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Peripheral arterial occlusive disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Peripheral artery aneurysm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Peripheral vein occlusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Thrombophlebitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <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="276" subjects_at_risk="304"/>
                <counts group_id="E2" subjects_affected="247" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Mitral valve prolapse</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Cerumen impaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Goitre</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Dermatochalasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Ocular hyperaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Retinoschisis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Vitreous detachment</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Dental caries</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="304"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Faecaloma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorder</sub_title>
                <counts group_id="E1" events="86" subjects_affected="71" subjects_at_risk="304"/>
                <counts group_id="E2" events="90" subjects_affected="77" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Intestinal polyp</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Pancreatic disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="304"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="64" subjects_affected="52" subjects_at_risk="304"/>
                <counts group_id="E2" events="65" subjects_affected="52" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Drug intolerance</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="297" subjects_affected="195" subjects_at_risk="304"/>
                <counts group_id="E2" events="299" subjects_affected="197" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Feeling hot</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Injection site bruising</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" events="55" subjects_affected="43" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" events="324" subjects_affected="213" subjects_at_risk="304"/>
                <counts group_id="E2" events="31" subjects_affected="30" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Injection site swelling</sub_title>
                <counts group_id="E1" events="45" subjects_affected="35" subjects_at_risk="304"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="42" subjects_affected="39" subjects_at_risk="304"/>
                <counts group_id="E2" events="36" subjects_affected="32" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Acute sinusitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Chronic sinusitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Fungal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Gingivitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="304"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Kidney infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Labyrinthitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Laryngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Localised infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="304"/>
                <counts group_id="E2" events="15" subjects_affected="13" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Oropharyngeal candidiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Otitis media acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Paronychia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Sweat gland infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="304"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arthropod bite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Chest injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Joint injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Meniscus injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Skin laceration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Thermal burn</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Hyperinsulinaemic hypoglycaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Type 2 diabetes mellitus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Vitamin D deficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Costochondritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Musculoskeletal stiffness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="153" subjects_affected="115" subjects_at_risk="304"/>
                <counts group_id="E2" events="116" subjects_affected="94" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="304"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Rotator cuff syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Spinal osteoarthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Synovial cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Tendon disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Tendonitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Tenosynovitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Squamous cell carcinoma of skin</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Focal dyscognitive seizures</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="178" subjects_affected="127" subjects_at_risk="304"/>
                <counts group_id="E2" events="145" subjects_affected="111" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Post herpetic neuralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Post polio syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Tension headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="304"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Panic attack</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Chromaturia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Urine odour abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Bartholin's cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Scrotal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Scrotal swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Bronchospasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="304"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Increased upper airway secretion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Nasal polyps</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Paranasal sinus discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Pharyngeal erythema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Pleuritic pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Pulmonary fibrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Pulmonary mass</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Sinus congestion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Sleep apnoea syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Sputum discoloured</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Sputum increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dandruff</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Dermal cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Photosensitivity reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Pruritus allergic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Psoriasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Skin lesion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="304"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Peripheral venous disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="304"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="302"/>
              </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/NCT03281876
org study id: 207489
secondary id: 2017-000880-34
nct id: NCT03281876
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to test if the vaccine is working well in COPD patients aged 40
      to 80 years old to reduce episodes of worsening symptoms ("exacerbations") and to gather
      further information on safety and immune response.

      In the current study, COPD patients with a history of acute exacerbations will receive 2
      doses of the investigational vaccine or placebo intramuscularly according to a 0, 2 month
      vaccination schedule, in addition to standard care.

      The effect of vaccination against two pathogens known to cause exacerbations (Non-typeable
      Haemophilus influenza [NTHi] and Moraxella catarrhalis [Mcat]) will be evaluated at
      pre-defined timepoints (scheduled study visits).

      In addition to the scheduled study visits, additional study visit(s) and/ or phone contact(s)
      will take place for each acute exacerbation of COPD occurring from first vaccination up to
      study conclusion.
The purpose of this Phase IIB proof-of-concept (POC) study in moderate to very severe COPD
      patients (i.e. GOLD grade 2, 3 and 4) aged 40 to 80 years with a history of moderate or
      severe acute exacerbations of COPD (AECOPD) in the previous 12 months is to evaluate whether
      the NTHi-Mcat vaccine can reduce the frequency of AECOPD in this population and to assess the
      vaccine's safety, reactogenicity and immunogenicity.

      Several formulations of a vaccine containing the NTHi antigens (low or high formulation)
      either non-adjuvanted or combined with different adjuvants (aluminium [Al], adjuvant system)
      were already evaluated in two previous Phase I clinical trials (NTHI-002 in healthy adults
      aged 18 - 40 years and NTHI-003 in current and former healthy smokers of 50-70 years old).
      The investigational vaccines were well-tolerated, with an acceptable safety and
      reactogenicity profile. These studies allowed the dose selection of the NTHi antigens (low
      formulation) and the adjuvant system currently evaluated for the first time in moderate and
      severe COPD patients aged 45 - 81 years in the Phase II study NTHI-004.

      The safety, reactogenicity and immunogenicity of different formulations of the NTHi-Mcat
      investigational vaccine have been evaluated in the Phase I study in healthy adults aged 19 -
      40 years and in current and former smokers aged 50 - 70 years (study NTHI MCAT-001). Based on
      results obtained up to 30 days post-Dose 2 from this study, the adjuvanted formulation
      containing NTHi proteins PD and PE-PilA and of UspA2 has been selected for evaluation in the
      current NTHI MCAT-002 study. Placebo will be used as a control. The NTHi-Mcat investigational
      vaccine and placebo will be given on top of standard of care to subjects in the respective
      study groups.

      In the current study, moderate, severe and very severe COPD patients (i.e. GOLD grade 2, 3
      and 4) with a history of AECOPD will receive 2 doses of the NTHi-Mcat investigational vaccine
      or placebo intramuscularly (IM) according to a 0, 2 month vaccination schedule, in addition
      to standard care.

      Scheduled study visits, during which the effect of immunisation against NTHi and Mcat will be
      evaluated, will take place at pre-defined timepoints.

      In addition to the scheduled study visits, ad hoc AECOPD-driven study visit(s) and/ or phone
      contact(s) will take place for each AECOPD occurring from first vaccination up to study
      conclusion:

        -  An AECOPD visit will be scheduled as soon as possible after the onset of the AECOPD
           symptoms (maximum 96 hours after the onset of the symptoms).

        -  Follow-up visit(s) and/or phone call(s) will take place to determine the end of the
           AECOPD.

      Rationale for the protocol amendment:

        -  CD8+ T cell component was removed from the secondary endpoint, but kept in the
           exploratory/tertiary endpoint. Previous clinical studies have shown that the
           investigational NTHi and NTHi-Mcat vaccines do not induce CD8+ T cell responses. This
           was observed in all studies performed with the NTHi vaccine and seen in the interim
           analysis of NTHi Mcat-001 study.

        -  An exclusion criterion was updated to clarify that only subjects with clinically
           significant respiratory diseases other than COPD (e.g. clinically significant lung
           fibrosis, clinically significant pulmonary embolism) need to be excluded from study
           participation.

        -  The polymerase chain reaction (PCR) assay for sputum samples was not designed to
           discriminate amongst Haemophilus influenzae (Hi) serotypes. Results from AERIS
           epidemiological study [Wilkinson, 2017] showed that more than 99% of these bacteria
           would be Non-Typeable Haemophilus influenzae (NTHi). Therefore, the protocol was updated
           to clarify that the presence of Hi bacteria in sputum during exacerbation will be used
           to determine AECOPD associated to NTHi.

        -  The list of potential immune mediated diseases was updated (effective June 30th 2017).

        -  The 87% confidence interval (CI) was removed from all secondary analyses. This
           confidence interval will only be maintained for the primary analysis because the 95% CIs
           are underpowered for this study. All other sensitivity analyses on different cohorts
           will be described using 95% CIs. As the primary objective will have both 87% and 95%,
           the sensitivity analyses can be interpreted with 95% CIs.

        -  A Full-Analysis Set (FAS) that corresponds to an intent-to-treat analysis was added. The
           FAS will include all randomized subjects who will receive at least 1 vaccine
           administration and, as per intention-to-treat principle, a subject in the FAS will be
           analysed "as randomized" (i.e. according to the vaccine a subject was planned to receive
           irrespectively of his/her real exposure).

        -  Cut-off values for anti-PE, anti-PilA and anti-UspA2 antibody ELISAs were updated
           following the re-set up of the assays.

        -  Additional minor updates were based on the scientific and operational experience gained
           from current COPD studies.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Phase IIB, randomised, observer-blind, placebo-controlled, multi-centric study with two parallel groups.
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Data will be collected in an observer-blind manner. By observer-blind, it is meant that during the course of the study, the vaccine recipient and those responsible for the evaluation of any study endpoint (e.g. safety, reactogenicity and efficacy) will all be unaware of whether vaccine or placebo was administered. Each study site is responsible for having a blinding plan. To work in an observer-blind manner, vaccine preparation and administration will be done by authorised medical personnel who will not participate in any of the study clinical evaluation assays. Two teams of study personnel will hence be set up:
A team of unblinded personnel (responsible for the preparation and the administration of the vaccines)
A team of blinded personnel (responsible for the clinical evaluation of the subjects).
measure: Rate of Moderate and Severe AECOPD (Any Cause)-Analysis (87% Confidence Interval [CI]), Post-dose 2 and Lasting for 1 Year
time frame: From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
description: Efficacy of the investigational vaccine was measured by the rate of moderate and severe AECOPD from 1-month post dose 2 up to study end (i.e. rate expressed per year and calculated as the total number of events over the follow-up exposure time). The CIs of the rate is computed using a model which accounts for repeated events. Anthonisen criteria used to detect potential AECOPD: Worsening of 2 or more of the following major symptoms for at least 2 consecutive days: dyspnoea, sputum volume, sputum purulence, OR Worsening of any major symptom together with any of the following minor symptoms for at least 2 consecutive days: sore throat, cold, fever without other cause, increased cough, increased wheeze. Moderate AECOPD requires treatment with systemic corticosteroids and/ or antibiotics. Severe AECOPD requires hospitalization. Confirmation of any AECOPD was as per investigator's judgement.
measure: Rate of Moderate and Severe AECOPD (Any Cause) -Analysis (95% CI), Post-dose 2 and Lasting for 1 Year
time frame: From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
description: Efficacy of the investigational vaccine was measured by the rate of moderate and severe AECOPD from 1-month post dose 2 up to study end (i.e. rate expressed per year and calculated as the total number of events over the follow-up exposure time). The CIs of the rate is computed using a model which accounts for repeated events. Anthonisen criteria used to detect potential AECOPD: Worsening of 2 or more of the following major symptoms for at least 2 consecutive days: dyspnoea, sputum volume, sputum purulence, OR Worsening of any major symptom together with any of the following minor symptoms for at least 2 consecutive days: sore throat, cold, fever without other cause, increased cough, increased wheeze. Moderate AECOPD requires treatment with systemic corticosteroids and/ or antibiotics. Severe AECOPD requires hospitalization. Confirmation of any AECOPD was as per investigator's judgement.
measure: Number of Subjects Reported With Each Solicited Local Adverse Event (AE)
time frame: During the 7-day follow-up period (the day of vaccination + 6 days) after each vaccination administered approximately at Day 1 and Day 61
description: Assessed solicited local symptoms were pain, redness and swelling
measure: Number of Subjects Reported With Each Solicited General AE
time frame: During the 7-day follow-up period (the day of vaccination + 6 days) after each vaccination administered approximately at Day 1 and Day 61
description: Assessed solicited general symptoms were Chills, fatigue, fever [defined as (oral cavity or axillary) temperature equal to or above (≥) 37.5 degrees Celsius (°C)], gastrointestinal symptoms [nausea, vomiting, diarrhoea and/or abdominal pain], headache and myalgia.
measure: Number of Subjects Reported With Any Unsolicited Adverse Event (AE)
time frame: During the 30-day follow-up period (the day of vaccination + 29 days) after each vaccination administered approximately at Day 1 and Day 61
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 any solicited symptoms.
measure: Number of Subjects Reported With Any Potential Immune-mediated Diseases (pIMDs)
time frame: From first vaccination (Day 1) up to Study end (at Day 451)
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.
measure: Number of Subjects Reported With Any Serious Adverse Event (SAE)
time frame: From first vaccination (Day 1) up to Study end (at Day 451)
description: SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity
measure: Rate of Moderate and Severe AECOPD in Vaccinated and Control Subjects, One Year Follow up Starting 1 Month Post Dose 2, by 3 Months Period
time frame: During following periods: from 0 to 3 months, from 3 to 6 months, from 6 to 9 months, from 9 to 12 months (observation starting 1 month post-Dose 2)
description: The rates of AECOPD were expressed per year and calculated as the total number of events over the follow-up exposure time. The CIs of the rate was computed using a model which accounts for repeated events. The severity of AECOPD can be graded according to the intensity of medical intervention required. Moderate AECOPD= requires treatment with systemic corticosteroids and/or antibiotics. Severe AECOPD= requires hospitalization. The intention of the analysis of the Rate during 3, 6 and 9 months observation starting 1 month post-Dose 2 was to report the rate by 3 months period, so for the periods: 0-3, 3-6, 6-9, 9-12 months.
measure: Rate of Any AECOPD Case in Vaccinated and Control Subjects, One Year Follow up Starting 1 Month Post Dose 2, by 3 Months Period
time frame: During following periods: from 0 to 3 months, from 3 to 6 months, from 6 to 9 months, from 9 to 12 months, 0-12 months (observation starting 1 month post-Dose 2)
description: The rates of any AECOPD were expressed per year and calculated as the total number of events over the follow-up exposure time. The CIs of the rate was computed using a model which accounts for repeated events. The intention of the analysis of the Rate during 3, 6, 9 and 12 months observation starting 1 month post-Dose 2 was to report the rate by 3 months period, so for the periods: 0-3, 3-6, 6-9, 9-12 and 0-12 months.
measure: Exacerbation Rate of Any AECOPD Cases, Classified by Severity, One Year Follow up Starting 1 Month Post Dose 2, by 3 Months Period
time frame: During following periods: from 0 to 3 months, from 3 to 6 months, from 6 to 9 months, from 9 to 12 months (observation starting 1 month post-Dose 2)
description: The exacerbation rate of any AECOPD by severity is the average number of exacerbations for each subject: It is calculated proportionally to the follow-up time per subject and then scaled to the period considered. Mean and standard deviation of the exacerbation rate are given for each period considered. The severity of AECOPD can be graded according to the intensity of medical intervention required. Mild = can be controlled with an increase in dosage of regular medications. Moderate AECOPD= requires treatment with systemic corticosteroids and/or antibiotics. Severe AECOPD= requires hospitalization. The intention of the analysis of the Rate during 3, 6 and 9 months observation starting 1 month post-Dose 2 was to report the rate by 3 months period, so for the periods: 0-3, 3-6, 6-9, 9-12 months.
measure: Number of Subjects With First Moderate or Severe AECOPD
time frame: From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
description: Number of subjects with first occurrence of moderate or severe episode of AECOPD was reported, in order to compute time to first occurrence and derive the hazard rate using Cox's proportional hazard regression model.
measure: Number of Subjects With First AECOPD of Any Severity
time frame: From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
description: Number of subjects with first occurrence of any episode of AECOPD of any severity was reported, in order to compute time to first occurrence and derive the hazard rate using Cox's proportional hazard regression model.
measure: Number of Subjects With First AECOPD Classified by Severity
time frame: From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
description: Number of subjects with first occurrence of any episode of AECOPD classified by severity was reported, in order to compute time to first occurrence and derive the hazard rate using Cox's proportional hazard regression model.
measure: Number of Days With Moderate and Severe AECOPDs
time frame: From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
description: The length of each AECOPD was tabulated and presented via descriptive statistics (mean, Standard Deviation) and expressed in Days.
measure: Number of Days With AECOPDs of Any Severity
time frame: From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
description: The length of each AECOPDs was tabulated and presented via descriptive statistics (mean, Standard Deviation).
measure: Number of Days With AECOPDs Classified by Severity
time frame: From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
description: The length of each AECOPDs by severity was tabulated and presented via descriptive statistics (mean, Standard Deviation).
measure: Rate of Non-Typeable Haemophilus Influenzae (NTHi)-Associated and/ or Moraxella Catarrhalis (Mcat)-Associated Moderate and Severe AECOPD
time frame: From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
description: The rates of AECOPD were expressed per year and calculated as the total number of events over the follow-up exposure time. The CIs of the rate was computed using a model which accounts for repeated events. Respiratory pathogens NTHi and Mcat was determined by Polymerase chain reaction (PCR) analysis in sputum samples.
measure: Rate of NTHi-associated and/ or Mcat-associated AECOPD of Any Severity
time frame: From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
description: The rates of AECOPD of any severity were expressed per year and calculated as the total number of events over the follow-up exposure time. The CIs of the rate was computed using a model which accounts for repeated events. Respiratory pathogens NTHi and Mcat was determined by polymerase chain reaction (PCR) analysis in sputum samples.
measure: Exacerbation Rate of Any NTHi-associated and/ or Mcat-associated AECOPD Cases, Classified by Severity
time frame: From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
description: The exacerbation rate of any AECOPD by severity is the average number of exacerbations for each subject: it is calculated proportionally to the follow-up time per subject, and then scaled to the period considered. Mean and standard deviation of the exacerbation rate are given for the period considered. Respiratory pathogens NTHi and Mcat was determined PCR analysis in sputum samples
measure: Number of Subjects With First Moderate or Severe NTHi-associated and/or Mcat-associated AECOPD
time frame: From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
description: Number of subjects with first occurrence of moderate or severe NTHI-associated and/or Mcat-associated AECOPD was reported,in order to compute time to first occurrence and derive the hazard rate using Cox's proportional hazard regression model. Respiratory pathogens NTHi and Mcat was determined PCR analysis in sputum samples.
measure: Number of Subjects With First NTHi-associated and/or Mcat-associated AECOPD of Any Severity
time frame: From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
description: Number of subjects with first occurrence of NTHI-associated and/or Mcat-associated AECOPD of any severity was reported,in order to compute time to first occurrence and derive the hazard rate using Cox's proportional hazard regression model. Respiratory pathogens NTHi and Mcat was determined PCR analysis in sputum samples.
measure: Number of Subjects With First NTHi-associated and/or Mcat-associated AECOPD, Classified by Severity
time frame: From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
description: Number of subjects with first occurrence of NTHI-associated and/or Mcat-associated AECOPD classified by severity was reported, in order to compute time to first occurrence and derive the hazard rate using Cox's proportional hazard regression model. Respiratory pathogens NTHi and Mcat was determined PCR analysis in sputum samples.
measure: Number of Days With Moderate and Severe NTHi-associated and Mcat-associated AECOPD
time frame: From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
description: The length of each NTHi associated and/or Mcat associated AECOPDs was tabulated and presented via descriptive statistics (mean, Standard Deviation).
measure: Number of Days With NTHi-associated and/or Mcat-associated AECOPDs of Any Severity
time frame: From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
description: The length of each NTHi associated and/or Mcat associated AECOPDs was tabulated and presented via descriptive statistics (mean, Standard Deviation).
measure: Number of Days With NTHi-associated and/or Mcat-associated AECOPD, Classified by Severity
time frame: From 1-month post-Dose 2 (at Day 91) up to study end (at Day 451)
description: The length of each NTHi associated and/or Mcat associated AECOPDs was tabulated and presented via descriptive statistics (mean, Standard Deviation).
measure: Anti-PD Antibody Concentrations as Measured by the Enzyme-Linked Immunosorbent Assay (ELISA)
time frame: At Day 1, Day 31, Day 61, Day 91, Day 271 and at Day 451
description: Anti-Protein D (PD) antibody concentrations as determined by ELISA, and expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EU/mL). For anti-PD antibodies, the cut-off of the assay is 153 ELISA Units per millilitre (EU/mL.)
measure: Anti-PE Antibody Concentrations as Measured by ELISA
time frame: At Day 1, Day 31, Day 61, Day 91, Day 271 and at Day 451
description: Anti-Protein E (PE) antibody concentrations as determined by ELISA and expressed as GMCs in EU/mL For Anti-PE antibodies, the cut-off of the assay is 16 EU/mL.
measure: Anti-PilA Antibody Concentrations as Measured by ELISA
time frame: At Day 1, Day 31, Day 61, Day 91, Day 271 and at Day 451
description: Anti-Type IV pilus assembly protein (PilA) antibody concentrations as determined by ELISA, and expressed as GMCs in EU/mL. For Anti-PilA antibodies, the cut-off of the assay is 8 EU/mL.
measure: Anti-UspA2 Antibody Concentrations as Measured by ELISA
time frame: At Day 1, Day 31, Day 61, Day 91, Day 271 and at Day 451
description: Anti-ubiquitous surface protein A2 of Moraxella catarrhalis (UspA2) aantibody concentrations as determined by ELISA, and expressed as GMCs in EU/mL. For Anti-UspA2 antibodies, the cut-off of the assay is 28 EU/mL.
measure: Frequency of PD Specific Cluster of Differentiation (CD)4+ T-cells Expressing at Least 2 Markers Among CD40L, IL2, TNF-Alpha, IFN-Gamma, IL-13 and IL-17 Using Background Reduced Frequency Data
time frame: At Day 1, Day 91, Day 271 and at Day 451
description: The ICS staining assay was used to assess cell-mediated immunogenicity (CMI) responses. After Peripheral blood mononuclear cell (PBMC) stimulation with the relevant antigen, the frequency of PD specific CD4+ T-cells expressing selected combination of cytokines such as interleukine-2, 13, 17 (IL-2, IL-13, IL-17), interferon-gamma (IFN-γ), tumour necrosis factor-alpha (TNF-α) and cluster of differentiation 40 ligand (CD40L) are evaluated by flow cytometry and expressed as mean and standard deviation.
measure: Frequency of PE Specific (CD)4+ T-cells Expressing at Least 2 Markers Among CD40L, IL2, TNF-Alpha, IFN-Gamma, IL-13 and IL-17 Using Background Reduced Frequency Data
time frame: At Day 1, Day 91, Day 271 and at Day 451
description: The ICS staining assay was used to assess CMI responses. After PBMC stimulation with the relevant antigen, the frequency of PE specific CD4+ T-cells expressing selected combination of cytokines such as (IL-2, IL-13, IL-17), IFN-γ, TNF-α and CD40L are evaluated by flow cytometry and expressed as mean and standard deviation.
measure: Frequency of PilA Specific CD4+ T-cells Expressing at Least 2 Markers Among CD40L, IL2, TNF-Alpha, IFN-Gamma, IL-13 and IL-17 Using Background Reduced Frequency Data
time frame: At Day 1, Day 91, Day 271 and at Day 451
description: The ICS staining assay was used to assess CMI responses. After PBMC stimulation with the relevant antigen, the frequency of PilA specific CD4+ T-cells expressing selected combination of cytokines such as IL-2, IL-13, IL-17, IFN-γ, TNF-α and CD40L are evaluated by flow cytometry and expressed as mean and standard deviation.
measure: Frequency of UspA2 Specific CD4 + T-cells Expressing at Least 2 Markers Among CD40L, IL2, TNF-Alpha, IFN-Gamma, IL-13 and IL-17 Using Background Reduced Frequency Data
time frame: At Day 1, Day 91, Day 271 and at Day 451
description: The ICS staining assay was used to assess CMI responses. After PBMC stimulation with the relevant antigen, the frequency of UspA2 specific CD4+ T-cells expressing selected combination of cytokines such as IL-2, IL-13, IL-17, IFN-γ, TNF-α and CD40L are evaluated by flow cytometry and expressed as mean and standard deviation.
arm group label: GSK3277511A Group
arm group type: Experimental
description: Healthy males and females, 40 to 80 years of age, who received two doses of the adjuvanted GSK3277511A investigational vaccine containing surface protein D (PD), protein E- type IV pilus assembly protein (PE-PilA,) and ubiquitous surface protein A2 (UspA2) at Day 1 and Day 61.
arm group label: CONTROL Group
arm group type: Placebo Comparator
description: Healthy males and females, 40 to 80 years of age, who received two doses of placebo vaccine at Day 1 and Day 61.
intervention type: Biological
intervention name: NTHi Mcat investigational vaccine (GSK3277511A)
description: Two doses administered intramuscularly at Day 1 and Day 61 in the deltoid region of the non-dominant arm.
arm group label: GSK3277511A Group
intervention type: Biological
intervention name: Placebo
description: Two doses administered intramuscularly at Day 1 and Day 61 in the deltoid region of the non-dominant arm.
arm group label: CONTROL Group
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
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country: Belgium
country: Canada
country: France
country: Germany
country: Italy
country: Spain
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Respiration Disorders
mesh term: Respiratory Tract Diseases
sharing ipd: Yes
ipd description: IPD for this study will be made available via the Clinical Study Data Request site.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study
ipd access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
ipd url: https://clinicalstudydatarequest.com
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